Famotidine

Zydus Lifesciences Ltd. has received final approval from the United States Food and Drug Administration (USFDA) to manufacture Ibuprofen and Famotidine tablets, 800 mg/26.6 mg. (USRLD: Duexis Tablets, 800 mg/26.6 mg). Ibuprofen and famotidine combination is indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers (gastric and/or duodenal ulcers), in patients who are taking ibuprofen for those indications. Ibuprofen and famotidine tablets will be produced at Zydus’ Ahmedabad facility. Ibuprofen and Famotidine tablets had annual sales of USD 3.6 mn in the United States (IQVIA MAT December 2024). The group now has 415 approvals and has so far filed 483 (as of December 31, 2024) ANDAs since the commencement of the filing process in FY 2003-04.

PHYRAGO™ Represents the First and Only Improved Version of SPRYCEL® That Can Be Safely Co-administered With Gastric Acid-Reducing Agents TAIPEI, TAIWAN / ACCESSWIRE / January 15, 2025 / Handa Pharmaceuticals, Inc. (\"Handa\") (6620.TWO) announced that its U.S. subsidiary, Handa Therapeutics, LLC (the \"Company\"), has acquired PHYRAGO™ (dasatinib) tablets, a U.S. Food and Drug Administration (\"FDA\") approved chronic myeloid leukemia treatment that was developed by Nanocopoeia, LLC. PHYRAGO™ is the first and only dasatinib product that can be co-administered with gastric acid-reducing agents. An estimated one-third of patients who require SPRYCEL® treatment may also take gastric acid-reducing agents1, which can reduce dasatinib\'s drug exposure by more than 40% when taken with a proton pump inhibitor and more than 60% when taken with an H2 receptor antagonist2.PHYRAGO™ was granted Orphan-Drug Designation and has received three (3) years of data exclusivity that will expire December 5, 2026. Should PHYRAGO™ be granted Orphan-Drug Exclusivity, it may be eligible for seven (7) years of exclusivity, until December 5, 2030. PHYRAGO™ is protected by several issued patents, including those listed in the FDA\'s Approved Drugs and Therapeutic Equivalents publication (the \"Orange Book\") that expire January 22, 2041.The Company is in the process of selecting a U.S. commercialization partner and expects PHYRAGO™ to be available to patients in Q1-2025.PHYRAGO™ is indicated for adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase and adult patients with Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) who no longer benefit from, or did not tolerate, other treatments.\"PHYRAGO™ represents a novel dasatinib formulation that delivers equivalent efficacy to SPRYCEL®, with the additional benefit of allowing patients to take dasatinib with gastric acid-reducing agents\", said Bill Liu, Chairman and CEO of Handa. \"Unlike SPRYCEL®, PHYRAGO™ allows concomitant use with a proton pump inhibitor or H2 receptor antagonist.\" The effect of co-administration of gastric acid-reducing agents on SPRYCEL® is significant. The SPRYCEL® label warns that the \"co-administration of SPRYCEL with a gastric acid-reducing agent may decrease the concentration of dasatinib. Decreased dasatinib concentrations may reduce efficacy. Do not administer H2 agonists or proton pump inhibitors with SPRYCEL.\"3The FDA approved PHYRAGO™ with a label that allows co-administration with gastric acid-reducing agents, stating that \"No clinically significant differences in the pharmacokinetics of PHYRAGO were observed following concomitant use with omeprazole (proton pump inhibitor) or famotidine (H2 receptor antagonist).\"4 and \"Avoid concomitant use of PHYRAGO with antacids. If concomitant use of an antacid cannot be avoided, administer the antacid at least 2 hours prior to or 2 hours after the dose of PHYRAGO.\"5According to Bristol Myers Squibb\'s annual report, net sales of SPRYCEL® in 2023 totaled $1.44 billion. For full prescribing information about PHYRAGO™, please visit www.phyrago.com.About Handa Pharmaceuticals, Inc.Handa is a specialty pharmaceutical company that focuses on developing high-quality medications that address significant unmet medical needs in oncology and neurology. Handa\'s leadership has a proven track record of building effective teams, high quality product portfolios and successful pharmaceutical businesses. For more information, please visit www.handapharma.com.Media Contact:Stephen D. Cary Senior Vice President[email protected]Tel: +1 510 354 3188Sources:IQVIA longitudinal prescription and medical claims data, January 2013-March 2021, identified 7,419 patients receiving dasatinib treatment of which 31.8% were concomitantly prescribed a proton pump inhibitor and/or H2 receptor antagonistSPRYCEL® Prescribing Information (Rev. 7/2024), Section 12.3, Pharmacokinetics - Drug Interaction Studies - Gastric Acid Reducing AgentsSPRYCEL® Prescribing Information (Rev. 7/2024), Section 7.1, Drug Interactions - Effect of Other Drugs on Dasatinib - Gastric Acid Reducing AgentsPHYRAGO™ Prescribing Information (Rev. 12/2024), Section 12.3, Pharmacokinetics - Drug Interaction Studies - Gastric Acid Reducing AgentsPHYRAGO™ Prescribing Information (Rev. 12/2024), Section 2.2, Dosage Modifications - AntacidsSOURCE: Handa Therapeutics, LLC.Related Documents: