Levomilnacipran Hydrochloride

NEW YORK, Sept. 23, 2022 /PRNewswire/ -- One of the key trends in the progesterone market is the rise in research and development of progesterone drugs. Various players are expanding their research to develop new formulations of the existing female infertility drugs due to the significant unmet demand. For instance, MVT-602 targets the kisspeptin system to stimulate reproductive hormones. It can effectively treat many reproductive disorders such as PCOS and hypothalamic amenorrhea (HA). Continue Reading Technavio has announced its latest market research report titled Global Progesterone Market 2022-2026 The progesterone market size is expected to grow by USD 1.23 billion. In addition, the growth momentum of the market will accelerate at a CAGR of 12.96% during the forecast period, according to Technavio. Get a comprehensive report summary describing the market size and forecast along with research methodology. The FREE sample report is available in PDF format The increasing prevalence of breast cancer is driving the progesterone market growth. However, factors such as stringent regulations may challenge the market growth during the forecast period. Progesterone Market: Type Landscape By type, the market has been segmented into synthetic progesterone and natural progesterone. The synthetic progesterone segment will be the largest contributor to market growth during the forecast period. Synthetic progesterone drugs help regulate the monthly menstrual cycle. Therefore, the advantages of synthetic progesterone will accelerate the market growth during the forecast period. Progesterone Market: Geographic Landscape By geography, the market has been segmented into North America, Europe, Asia, and Rest of World (ROW). North America is going to have lucrative growth during the forecast period. About 43% of the market's overall growth is expected to originate from North America. The US and Canada are the key countries for the progesterone market in North America. The growth of the region is attributed to factors such as the rising prevalence of kidney, breast, or uterine cancer types and the rising population of menopausal women. Some Key Companies and their Offerings AbbVie Inc., Alkem Laboratories Ltd., Aquatic Group, Bionpharma Inc., Blubell Pharma Group, Cadila Pharmaceuticals Ltd., Caesar and Loretz GmbH, Cipla Ltd., Dr. Reddys Laboratories Ltd., Estrellas Life Sciences Pvt. Ltd., Fagron NV, Glenmark Pharmaceuticals Ltd, Hikma Pharmaceuticals Plc, Intas Pharmaceuticals Ltd., Kiama Lifesciences, Lupin Ltd., Organon and Co., PROCAPS S.A, Teva Pharmaceutical Industries Ltd., Virtus Pharmaceuticals LLC, among others, are the main players in the market. The key offerings of some of these vendors are listed below: Alkem Laboratories Ltd. - The company offers ULTIGEST SR 200MG TAB as medication for a hormone prescribed for replacement therapy in women who have passed menopause. Aquatic Group - The company offers injection I.P Luteum Depot as progesterone drugs. Bionpharma Inc. - The company manufactures progesterone drugs. Blubell Pharma Group - The company offers BELGEST 500 and BELGEST N under the injection section as progesterone. Cadila Pharmaceuticals Ltd. - The company offers ALGEST SR 400MG tab as progesterone drugs, which are made using milk-making glands to help in the menstrual cycle. This report provides a full list of key vendors, their strategies, and the latest developments. Request a FREE PDF Sample Now What our Reports Offer Market share assessments for the regional-level and country-level segments Strategic recommendations for the new entrants Covers market data for 2021, 2022, until 2026 Market trends (opportunities, drivers, threats, challenges, investment opportunities, and recommendations) Strategic recommendations in key business segments based on the market estimations Competitive landscaping mapping the key common trends Company profiling with financials, detailed strategies, and recent developments Supply chain trends mapping the latest technological advancements Related Reports Women's Health Therapeutics Market by Type and Geography - Forecast and Analysis 2022-2026: The women's health therapeutics market share is expected to increase by USD 30.35 billion from 2021 to 2026. Stem Cell Umbilical Cord Blood (UCB) Market by End-user and Geography - Forecast and Analysis 2022-2026: The stem cell umbilical cord blood (UCB) market share is expected to increase by USD 1.47 bn from 2021 to 2026. Browse Health Care Market Reports Table of Contents 1 Executive Summary 1.1 Market overview Exhibit 01: Executive Summary – Chart on Market Overview Exhibit 02: Executive Summary – Data Table on Market Overview Exhibit 03: Executive Summary – Chart on Global Market Characteristics Exhibit 04: Executive Summary – Chart on Market by Geography Exhibit 05: Executive Summary – Chart on Market Segmentation by Type Exhibit 06: Executive Summary – Chart on Incremental Growth Exhibit 07: Executive Summary – Data Table on Incremental Growth Exhibit 08: Executive Summary – Chart on Vendor Market Positioning 2 Market Landscape 2.1 Market ecosystem Exhibit 09: Parent market Exhibit 10: Market Characteristics 3 Market Sizing 3.1 Market definition Exhibit 11: Offerings of vendors included in the market definition 3.2 Market segment analysis Exhibit 12: Market segments 3.3 Market size 2021 3.4 Market outlook: Forecast for 2021-2026 Exhibit 13: Chart on Global - Market size and forecast 2021-2026 ($ million) Exhibit 14: Data Table on Global - Market size and forecast 2021-2026 ($ million) Exhibit 15: Chart on Global Market: Year-over-year growth 2021-2026 (%) Exhibit 16: Data Table on Global Market: Year-over-year growth 2021-2026 (%) 4 Five Forces Analysis 4.1 Five forces summary Exhibit 17: Five forces analysis - Comparison between 2021 and 2026 4.2 Bargaining power of buyers Exhibit 18: Chart on Bargaining power of buyers – Impact of key factors 2021 and 2026 4.3 Bargaining power of suppliers Exhibit 19: Bargaining power of suppliers – Impact of key factors in 2021 and 2026 4.4 Threat of new entrants Exhibit 20: Threat of new entrants – Impact of key factors in 2021 and 2026 4.5 Threat of substitutes Exhibit 21: Threat of substitutes – Impact of key factors in 2021 and 2026 4.6 Threat of rivalry Exhibit 22: Threat of rivalry – Impact of key factors in 2021 and 2026 4.7 Market condition Exhibit 23: Chart on Market condition - Five forces 2021 and 2026 5 Market Segmentation by Type 5.1 Market segments Exhibit 24: Chart on Type - Market share 2021-2026 (%) Exhibit 25: Data Table on Type - Market share 2021-2026 (%) 5.2 Comparison by Type Exhibit 26: Chart on Comparison by Type Exhibit 27: Data Table on Comparison by Type 5.3 Synthetic progesterone - Market size and forecast 2021-2026 Exhibit 28: Chart on Synthetic progesterone - Market size and forecast 2021-2026 ($ million) Exhibit 29: Data Table on Synthetic progesterone - Market size and forecast 2021-2026 ($ million) Exhibit 30: Chart on Synthetic progesterone - Year-over-year growth 2021-2026 (%) Exhibit 31: Data Table on Synthetic progesterone - Year-over-year growth 2021-2026 (%) 5.4 Natural progesterone - Market size and forecast 2021-2026 Exhibit 32: Chart on Natural progesterone - Market size and forecast 2021-2026 ($ million) Exhibit 33: Data Table on Natural progesterone - Market size and forecast 2021-2026 ($ million) Exhibit 34: Chart on Natural progesterone - Year-over-year growth 2021-2026 (%) Exhibit 35: Data Table on Natural progesterone - Year-over-year growth 2021-2026 (%) 5.5 Market opportunity by Type Exhibit 36: Market opportunity by Type ($ million) 6 Customer Landscape 6.1 Customer landscape overview Exhibit 37: Analysis of price sensitivity, lifecycle, customer purchase basket, adoption rates, and purchase criteria 7 Geographic Landscape 7.1 Geographic segmentation Exhibit 38: Chart on Market share by geography 2021-2026 (%) Exhibit 39: Data Table on Market share by geography 2021-2026 (%) 7.2 Geographic comparison Exhibit 40: Chart on Geographic comparison Exhibit 41: Data Table on Geographic comparison 7.3 North America - Market size and forecast 2021-2026 Exhibit 42: Chart on North America - Market size and forecast 2021-2026 ($ million) Exhibit 43: Data Table on North America - Market size and forecast 2021-2026 ($ million) Exhibit 44: Chart on North America - Year-over-year growth 2021-2026 (%) Exhibit 45: Data Table on North America - Year-over-year growth 2021-2026 (%) 7.4 Europe - Market size and forecast 2021-2026 Exhibit 46: Chart on Europe - Market size and forecast 2021-2026 ($ million) Exhibit 47: Data Table on Europe - Market size and forecast 2021-2026 ($ million) Exhibit 48: Chart on Europe - Year-over-year growth 2021-2026 (%) Exhibit 49: Data Table on Europe - Year-over-year growth 2021-2026 (%) 7.5 Asia - Market size and forecast 2021-2026 Exhibit 50: Chart on Asia - Market size and forecast 2021-2026 ($ million) Exhibit 51: Data Table on Asia - Market size and forecast 2021-2026 ($ million) Exhibit 52: Chart on Asia - Year-over-year growth 2021-2026 (%) Exhibit 53: Data Table on Asia - Year-over-year growth 2021-2026 (%) 7.6 Rest of World (ROW) - Market size and forecast 2021-2026 Exhibit 54: Chart on Rest of World (ROW) - Market size and forecast 2021-2026 ($ million) Exhibit 55: Data Table on Rest of World (ROW) - Market size and forecast 2021-2026 ($ million) Exhibit 56: Chart on Rest of World (ROW) - Year-over-year growth 2021-2026 (%) Exhibit 57: Data Table on Rest of World (ROW) - Year-over-year growth 2021-2026 (%) 7.7 US - Market size and forecast 2021-2026 Exhibit 58: Chart on US - Market size and forecast 2021-2026 ($ million) Exhibit 59: Data Table on US - Market size and forecast 2021-2026 ($ million) Exhibit 60: Chart on US - Year-over-year growth 2021-2026 (%) Exhibit 61: Data Table on US - Year-over-year growth 2021-2026 (%) 7.8 Germany - Market size and forecast 2021-2026 Exhibit 62: Chart on Germany - Market size and forecast 2021-2026 ($ million) Exhibit 63: Data Table on Germany - Market size and forecast 2021-2026 ($ million) Exhibit 64: Chart on Germany - Year-over-year growth 2021-2026 (%) Exhibit 65: Data Table on Germany - Year-over-year growth 2021-2026 (%) 7.9 UK - Market size and forecast 2021-2026 Exhibit 66: Chart on UK - Market size and forecast 2021-2026 ($ million) Exhibit 67: Data Table on UK - Market size and forecast 2021-2026 ($ million) Exhibit 68: Chart on UK - Year-over-year growth 2021-2026 (%) Exhibit 69: Data Table on UK - Year-over-year growth 2021-2026 (%) 7.10 Canada - Market size and forecast 2021-2026 Exhibit 70: Chart on Canada - Market size and forecast 2021-2026 ($ million) Exhibit 71: Data Table on Canada - Market size and forecast 2021-2026 ($ million) Exhibit 72: Chart on Canada - Year-over-year growth 2021-2026 (%) Exhibit 73: Data Table on Canada - Year-over-year growth 2021-2026 (%) 7.11 France - Market size and forecast 2021-2026 Exhibit 74: Chart on France - Market size and forecast 2021-2026 ($ million) Exhibit 75: Data Table on France - Market size and forecast 2021-2026 ($ million) Exhibit 76: Chart on France - Year-over-year growth 2021-2026 (%) Exhibit 77: Data Table on France - Year-over-year growth 2021-2026 (%) 7.12 Market opportunity by geography Exhibit 78: Market opportunity by geography ($ million) 8 Drivers, Challenges, and Trends 8.1 Market drivers 8.2 Market challenges 8.3 Impact of drivers and challenges Exhibit 79: Impact of drivers and challenges in 2021 and 2026 8.4 Market trends 9 Vendor Landscape 9.1 Overview 9.2 Vendor landscape Exhibit 80: Overview on Criticality of inputs and Factors of differentiation 9.3 Landscape disruption Exhibit 81: Overview on factors of disruption 9.4 Industry risks Exhibit 82: Impact of key risks on business 10 Vendor Analysis 10.1 Vendors covered Exhibit 83: Vendors covered 10.2 Market positioning of vendors Exhibit 84: Matrix on vendor position and classification 10.3 Alkem Laboratories Ltd. Exhibit 85: Alkem Laboratories Ltd. - Overview Exhibit 86: Alkem Laboratories Ltd. - Business segments Exhibit 87: Alkem Laboratories Ltd. - Key news Exhibit 88: Alkem Laboratories Ltd. - Key offerings Exhibit 89: Alkem Laboratories Ltd. - Segment focus 10.4 Aquatic Group Exhibit 90: Aquatic Group - Overview Exhibit 91: Aquatic Group - Product / Service Exhibit 92: Aquatic Group - Key offerings 10.5 Bionpharma Inc. Exhibit 93: Bionpharma Inc. - Overview Exhibit 94: Bionpharma Inc. - Product / Service Exhibit 95: Bionpharma Inc. - Key offerings 10.6 Blubell Pharma Group Exhibit 96: Blubell Pharma Group - Overview Exhibit 97: Blubell Pharma Group - Product / Service Exhibit 98: Blubell Pharma Group - Key offerings 10.7 Cadila Pharmaceuticals Ltd. Exhibit 99: Cadila Pharmaceuticals Ltd. - Overview Exhibit 100: Cadila Pharmaceuticals Ltd. - Business segments Exhibit 101: Cadila Pharmaceuticals Ltd. - Key offerings Exhibit 102: Cadila Pharmaceuticals Ltd. - Segment focus 10.8 Estrellas Life Sciences Pvt. Ltd. Exhibit 103: Estrellas Life Sciences Pvt. Ltd. - Overview Exhibit 104: Estrellas Life Sciences Pvt. Ltd. - Product / Service Exhibit 105: Estrellas Life Sciences Pvt. Ltd. - Key offerings 10.9 Intas Pharmaceuticals Ltd. Exhibit 106: Intas Pharmaceuticals Ltd. - Overview Exhibit 107: Intas Pharmaceuticals Ltd. - Product / Service Exhibit 108: Intas Pharmaceuticals Ltd. - Key offerings 10.10 PROCAPS S.A Exhibit 109: PROCAPS S.A - Overview Exhibit 110: PROCAPS S.A - Product / Service Exhibit 111: PROCAPS S.A - Key offerings 10.11 Teva Pharmaceutical Industries Ltd. Exhibit 112: Teva Pharmaceutical Industries Ltd. - Overview Exhibit 113: Teva Pharmaceutical Industries Ltd. - Business segments Exhibit 114: Teva Pharmaceutical Industries Ltd. - Key news Exhibit 115: Teva Pharmaceutical Industries Ltd. - Key offerings Exhibit 116: Teva Pharmaceutical Industries Ltd. - Segment focus 10.12 Virtus Pharmaceuticals LLC Exhibit 117: Virtus Pharmaceuticals LLC - Overview Exhibit 118: Virtus Pharmaceuticals LLC - Product / Service Exhibit 119: Virtus Pharmaceuticals LLC - Key offerings 11 Appendix 11.1 Scope of the report 11.2 Inclusions and exclusions checklist Exhibit 120: Inclusions checklist Exhibit 121: Exclusions checklist 11.3 Currency conversion rates for US$ Exhibit 122: Currency conversion rates for US$ 11.4 Research methodology Exhibit 123: Research methodology Exhibit 124: Validation techniques employed for market sizing Exhibit 125: Information sources 11.5 List of abbreviations Exhibit 126: List of abbreviations About Us Technavio is a leading global technology research and advisory company. Their research and analysis focus on emerging market trends and provide actionable insights to help businesses identify market opportunities and develop effective strategies to optimize their market positions. With over 500 specialized analysts, Technavio's report library consists of more than 17,000 reports and counting, covering 800 technologies, spanning across 50 countries. Their client base consists of enterprises of all sizes, including more than 100 Fortune 500 companies. This growing client base relies on Technavio's comprehensive coverage, extensive research, and actionable market insights to identify opportunities in existing and potential markets and assess their competitive positions within changing market scenarios. Contact Technavio Research Jesse Maida Media & Marketing Executive US: +1 844 364 1100 UK: +44 203 893 3200 Email: [email protected] Website: SOURCE Technavio

Get the latest biotech news where you want it. Sign up for the free GenePool newsletter today! Forest Laboratories and Pierre Fabre Laboratories Announce FDA Approval of FETZIMA™ for the Treatment of Major Depressive Disorder in Adults NEW YORK & CASTRES, France--(BUSINESS WIRE)-- Forest Laboratories, Inc. (FRX) and Pierre Fabre Laboratories announced today that FETZIMA™ (levomilnacipran extended-release capsules), a once-daily serotonin and norepinephrine reuptake inhibitor (SNRI), discovered by Pierre Fabre Laboratories and co-developed by Forest Laboratories, Inc. was approved by the U.S. Food and Drug Administration (FDA) for the treatment of Major Depressive Disorder (MDD) in adults. Major Depressive Disorder, also known as depression, is a common debilitating disorder in which feelings of sadness and other symptoms interfere with a person’s ability to work, sleep, study, eat, and enjoy once-pleasurable activities. MDD affects almost 16 million adults in the United States every year, with a range of severity from mild to severe. In the placebo-controlled, pivotal Phase III studies of adult patients with MDD, statistically significant and clinically meaningful improvement in depressive symptoms (primary endpoint) was demonstrated across three FETZIMA dosage strengths of 40, 80, and 120 mg once daily compared with placebo as measured by the Montgomery Åsberg Depression Rating Scale (MADRS) total score (primary endpoint). FETZIMA also demonstrated superiority over placebo as measured by improvement in the Sheehan Disability Scale (SDS) functional impairment total score (secondary endpoint). “Because people respond differently to different medications, Forest Laboratories is dedicated to bringing a range of treatment possibilities to adults living with MDD, as part of our growing mental health portfolio,” said Howard Solomon, Chairman, Chief Executive Officer and President of Forest Laboratories. “The approval of FETZIMA fulfills that commitment to the millions of people living with MDD.” "We are proud that another product stemming from Pierre Fabre’s research has received approval in the United States. This marketing authorisation represents a key milestone for our laboratory, and it confirms our choice to make neuropsychiatry a strategic axis of our R&D efforts, next to oncology and dermatology ", said Frédéric Duchesne, President Pharmaceutical Division, Pierre Fabre Laboratories. The most common adverse reactions (incidence =5% and at least twice the rate of placebo) in the placebo-controlled trials were nausea, constipation, hyperhidrosis, heart rate increased, erectile dysfunction, tachycardia, vomiting, and palpitations. Rates of adverse events were generally consistent across doses (40-120 mg); the only dose-related adverse events (greater than 2% overall incidence) were urinary hesitation and erectile dysfunction. “As many people with MDD struggle to find a treatment that works for them, FETZIMA provides patients and physicians with an additional option for treating this serious disease,” said Michael Liebowitz, MD, Professor of Clinical Psychiatry at Columbia University. Forest Laboratories Inc. expects FETZIMA to be available to wholesalers in the 4th calendar quarter 2013. Data Highlights The efficacy of FETZIMA was demonstrated in three positive double-blind Phase III studies comprising two fixed-dose studies and one flexible-dose study that compared FETZIMA to placebo in adults with MDD. A total of more than 1,600 adult patients received a once-daily dose of either FETZIMA (40, 80, 120mg) or placebo in the three studies. In each study, the primary endpoint was change from baseline to endpoint in the Montgomery Åsberg Depression Rating Scale (MADRS) total score and the secondary endpoint was change from baseline to endpoint in the Sheehan Disability Scale (SDS) total score. In all three studies, statistically significant improvement was seen for the FETZIMA group compared with placebo on both the primary and secondary endpoints using both the mixed-effects model for repeated measures (MMRM) and last-observation-carried-forward (LOCF) analyses. Primary Endpoint MADRS (Reduction in depressive symptoms) In all three studies, FETZIMA demonstrated superiority over placebo in the improvement of depressive symptoms as measured by the change from baseline to Week 8 in the MADRS total score. MADRS is a widely used, clinician-rated scale to assess the severity of 10 depressive symptoms. A total MADRS score of 35 or greater is suggestive of severe depression. The primary efficacy endpoint in the pivotal trials was change from baseline to week 8 in the total MADRS score. A 2-point difference between drug effect and placebo is generally considered to represent a clinically meaningful improvement in depressive symptoms. For study 1, the mean baseline MADRS total score was 36 for all treatment groups. The LS mean difference from placebo in change from baseline was statistically significant at all three FETZIMA doses (-3.2 at 40 mg/day, -4.0 at 80 mg/day, and -4.9 at 120 mg/day). For study 2, the mean baseline MADRS total score was 31 for all treatment groups. The LS mean difference from placebo in change from baseline was statistically significant at both FETZIMA doses studied (-3.3 at 40 mg/day, -3.1 at 80 mg/day). For study 3, the mean baseline MADRS total score was 35 for all treatment groups. The LS mean difference from placebo in change from baseline was statistically significant for the FETZIMA dosing range studied (-3.1 at 40-120 mg/day). Secondary Endpoint SDS (Improvement in functional impairment) FETZIMA also demonstrated superiority over placebo as measured by improvement in the Sheehan Disability Scale (SDS) functional impairment total score. SDS is a validated scale that measures the extent that emotional symptoms disrupt patient functioning in 3 life domains: work/school, social life, and family life with each item scored from 0 (unimpaired) to 10 (highly impaired). About Major Depressive Disorder MDD is a serious medical condition often requiring treatment, affecting almost 16 million adults in the United States yearly or approximately 7.3% of the adult U.S. population. MDD, also known as depression, is a common debilitating disorder in which feelings of sadness and other symptoms occur nearly every day for at least two weeks and interfere with a person’s ability to work, sleep, study, eat, and enjoy once-pleasurable activities. Depression costs the U.S. an estimated $44 billion each year. Among all medical illnesses, MDD is a leading cause of disability in the U.S. The World Health Organization predicts depression will become the second leading cause of disability by the year 2020. About FETZIMA FETZIMA is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of Major Depressive Disorder (MDD). The recommended therapeutic dose range for FETZIMA is 40 mg to 120 mg once daily and can be taken with or without food. While the exact mechanism is unknown, it is thought to be related to the potentiation of serotonin and norepinephrine in the central nervous system, through inhibition of reuptake at serotonin and norepinephrine transporters. Non-clinical studies have shown that FETZIMA is a potent and selective serotonin and norepinephrine reuptake inhibitor. Levomilnacipran was licensed to Forest Laboratories Inc. by Pierre Fabre, in the U.S. and Canada. Pierre-Fabre will also be the active pharmaceutical ingredient (API) supplier. Visit FETZIMA.com for more information on this once-daily option for the treatment of MDD in adults. FETZIMA Indication and Usage FETZIMA is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of Major Depressive Disorder (MDD). FETZIMA is not approved for the management of fibromyalgia. Efficacy and safety of FETZIMA for the management of fibromyalgia have not been established. Important Safety Information WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older. In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber. FETZIMA is not approved for use in pediatric patients. Contraindications FETZIMA is contraindicated in patients with a hypersensitivity to levomilnacipran, milnacipran HCl, or to any excipient in the formulation. The use of MAOIs intended to treat psychiatric disorders with FETZIMA or within 7 days of stopping treatment with FETZIMA is contraindicated due to an increased risk of serotonin syndrome. The use of FETZIMA within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated. Starting FETZIMA in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated due to an increased risk of serotonin syndrome. Do not use FETZIMA in patients with uncontrolled narrow-angle glaucoma. Warnings and Precautions All patients being treated with antidepressants should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the first few months of treatment and when increasing or decreasing the dose. Consider changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse or includes symptoms of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, mania, or suicidality that are severe, abrupt in onset, or were not part of the patient's presenting symptoms. Families and caregivers of patients being treated with antidepressants should be alerted about the need to monitor patients daily. Prescriptions for FETZIMA should be written for the smallest quantity of capsules consistent with good patient management, in order to reduce the risk of overdose. Serotonin Syndrome: The development of a potentially life-threatening serotonin syndrome has been reported with SNRIs and SSRIs both when taken alone, but especially when co-administered with other serotonergic agents (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John’s Wort) and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue). Symptoms of serotonin syndrome may include mental status changes (eg, agitation, hallucinations, delirium, and coma), autonomic instability (eg, tachycardia, labile blood pressure, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (eg, tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and/or gastrointestinal symptoms. If symptoms of serotonin syndrome occur, discontinue FETZIMA and initiate supportive treatment. If concomitant use of FETZIMA with other serotonergic drugs is clinically warranted, patients should be aware of a potential increased risk for serotonin syndrome, particularly during treatment initiation and dose increases. SNRIs, including FETZIMA, have been associated with increases in blood pressure. Blood pressure should be measured prior to initiating treatment and periodically throughout FETZIMA treatment. Pre-existing hypertension should be controlled before initiating treatment with FETZIMA. For patients who experience a sustained increase in blood pressure, discontinuation or other appropriate medical intervention should be considered. SNRIs including FETZIMA have been associated with an increase in heart rate. Heart rate should be measured prior to initiating treatment and periodically throughout FETZIMA treatment. Pre-existing tachyarrhythmias and other cardiac disease should be treated before starting therapy with FETZIMA. For patients who experience a sustained increase in heart rate, discontinuation or other appropriate medical intervention should be considered. SSRIs and SNRIs, including FETZIMA, may increase the risk of bleeding events, some serious. Concomitant use of aspirin, warfarin, NSAIDs and other anticoagulants may add to this risk. Mydriasis has been reported in association with SNRIs including FETZIMA; therefore, FETZIMA should be used with caution in patients with controlled narrow-angle glaucoma. Patients with raised intraocular pressure should be monitored. DO NOT use FETZIMA in patients with uncontrolled narrow-angle glaucoma. SNRIs, including FETZIMA, can affect urethral resistance. Caution is advised when using FETZIMA in patients prone to obstructive urinary disorders. Symptoms of mania/hypomania were reported in 0.2% of FETZIMA-treated patients and 0.2% of placebo-treated patients in clinical studies. As with all antidepressants, FETZIMA should be used cautiously in patients with a history or family history of bipolar disorder, mania or hypomania. Prior to initiating treatment with FETZIMA, patients should be adequately screened to determine if they are at risk for bipolar disorder. FETZIMA is not approved for use in treating bipolar depression. FETZIMA should be prescribed with caution in patients with a seizure disorder. Discontinuation symptoms, some serious, have been reported with discontinuation of serotonergic antidepressants such as FETZIMA. Gradual dose reduction is recommended, instead of abrupt discontinuation, whenever possible. Monitor patients when discontinuing FETZIMA. If intolerable symptoms occur following a dose decrease or upon discontinuation of treatment, consider resuming the previously prescribed dose and decreasing the dose at a more gradual rate. Advise patients that if they are treated with diuretics or are otherwise volume depleted, or are elderly, they may be at greater risk of developing hyponatremia while taking FETZIMA. Although no cases of hyponatremia resulting from FETZIMA treatment were reported in the clinical studies, hyponatremia has occurred as a result of treatment with SSRIs and SNRIs. FETZIMA should be discontinued in patients with symptomatic hyponatremia and appropriate medical intervention should be instituted. Adverse Reactions The most commonly observed adverse reactions in MDD patients treated with FETZIMA in placebo-controlled studies (incidence =5% and at least twice the rate of placebo) were: nausea, constipation, hyperhidrosis, heart rate increased, erectile dysfunction, tachycardia, vomiting, and palpitations. About Pierre Fabre Pierre Fabre Laboratories, the second largest independent pharmaceutical group in France, achieved a turnover of 1.98 billion Euros in 2012, with international sales accounting for 54%. Pierre Fabre has branches in 42 countries and its products are distributed in over 130 countries. Through the holding company Pierre Fabre Participations, 65% of Pierre Fabre SA is held by the Pierre Fabre Foundation, recognized as a public utility since 1999. In addition, thanks to an employee shareholding program set up in 2005, 90% of the company’s employees collectively have a 7 % shareholding interest. This original governance program ensures the independence and sustainability of the company. Their activities cover all aspects of healthcare, from prescription drugs and family health products to dermo-cosmetics. Pierre Fabre Laboratories employ some 10,000 people worldwide, 1,400 of whom are dedicated to R&D. Every year, the group allocates 20% of its drug revenues to R&D, focusing on three main areas: oncology, dermatology and neuropsychiatry. With brands including Avène, Glytone, A-Derma, Ducray, Galénic, Klorane, Naturactive, René Furterer or Pierre Fabre Oral Care, Pierre Fabre Laboratories are France’s market leaders when it comes to skin, hair and oral care products sold in the pharmacy channel. Avène is marketed in over 100 countries, and is the leading dermo-cosmetics brand in Europe, Japan and China. In prescription drugs, Pierre Fabre focuses on four therapeutic areas: oncology, dermatology, neuropsychiatry and women’s health. In oncology, Pierre Fabre achieves about 90% of its turnover outside its home country. In 2012, Pierre Fabre Laboratories was audited by the French certification group AFNOR at advanced level for its corporate social responsibility (CSR) performance. To learn more, visit About Forest Laboratories, Inc. Forest Laboratories' (FRX) longstanding global partnerships and track record developing and marketing pharmaceutical products in the United States have yielded its well-established central nervous system and cardiovascular franchises and innovations in anti-infective, respiratory, gastrointestinal and pain management medicine. Forest’s pipeline, the most robust in its history, includes product candidates in all stages of development across a wide range of therapeutic areas. The Company is headquartered in New York, NY. To learn more, visit Except for the historical information contained herein, this release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve a number of risks and uncertainties, including the difficulty of predicting FDA approvals, the acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, the timely development and launch of new products, and the risk factors listed from time to time in Forest Laboratories' Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and any subsequent SEC filings. Forest assumes no obligation to update forward-looking statements contained in this release to reflect new information or future events or developments. Contact: Forest Laboratories, Inc. Frank J. Murdolo, 212-224-6714 Vice President – Investor Relations media.relations@frx.com Help employers find you! Check out all the jobs and post your resume.