Prospective, multi-center, open-label study to evaluate the effectiveness and safety of chlordiazepoxide in mild to moderate Alcohol withdrawal syndrome patients using CIWA-Ar scale in Deaddiction centers

Start Date10 Jul 2025

Sponsor / Collaborator

Abbott Healthcare Pvt Ltd.

IRCT20220211053992N45

/ RecruitingNot ApplicableIIT

In vivo fasted-state bioequivalence study of Chlordiazepoxide 10 mg Tablets manufactured by Mehrdarou Pharmaceutical Co. compared to innovator product

Start Date20 Nov 2024

Sponsor / Collaborator

Tabriz University of Medical Sciences

100 Clinical Results associated with Chlordiazepoxide

100 Translational Medicine associated with Chlordiazepoxide

100 Patents (Medical) associated with Chlordiazepoxide

4,460

Literatures (Medical) associated with Chlordiazepoxide

01 Jul 2026·PHARMACOLOGY BIOCHEMISTRY AND BEHAVIOR

Acute chlordiazepoxide increases risky choice in rats and repeated administration attenuates this effect

Article

Author: Anderson, Karen G ; Galdieri, Devin A ; Mahoney, Carson C ; Nolder, Katya A

Risky choice is a defining feature of many psychological disorders and maladaptive behavior. There is evidence that benzodiazepines, a class of drugs that act on the GABA system, may increase risky choice. Long-term use of these medications is common, but relatively little is known about how repeated/chronic use of benzodiazepines affects risky decision making. The present study examined effects of acute and repeated chlordiazepoxide, a prototypic benzodiazepine, on probability discounting in eight male Sprague-Dawley rats. The probability-discounting task involved choices between a single food pellet with guaranteed delivery and three food pellets with decreasing probabilities of delivery across each experimental session. Risky choice was operationally defined as choice for the larger, uncertain reinforcer over the smaller, certain reinforcer. During baseline, responding was sensitive to the programmed contingencies, and larger-reinforcer choice decreased as the probability of delivery decreased. Acute administration of chlordiazepoxide (1.0-30.0 mg/kg) dose-dependently increased risky choice and trial omissions. Tolerance to chlordiazepoxide's effects on these outcomes was observed after repeated 10.0 mg/kg administration. The results of the present study indicate that acute chlordiazepoxide can increase risky choice in a probability-discounting task and that tolerance to this effect develops after chronic exposure to the drug. Limitations of the present study are discussed, as are directions for future research on benzodiazepines and risky choice.

01 Apr 2026·JHEP Reports

Safety and effectiveness of phenobarbital vs. benzodiazepines for severe alcohol withdrawal in alcohol-associated liver disease in the ICU

Article

Author: Govalan, Rajalakshmi ; Hao, Shengchen ; Kenes, Michael T ; McSparron, Jakob I ; Tapper, Elliot B

BACKGROUND & AIMS:

Severe alcohol withdrawal syndrome (SAWS) in patients with alcohol-associated liver disease (ALD) presents management challenges due to altered drug metabolism and increased toxicity. While benzodiazepines remain standard therapy, concerns about drug shortages, over-sedation, hepatic encephalopathy, and respiratory depression have prompted interest in phenobarbital as an alternative.

METHODS:

We conducted a retrospective cohort study using the MIMIC-IV database (2008-2019) comparing phenobarbital and benzodiazepines in patients in the intensive care unit (ICU) with ALD and SAWS. Patients receiving either drug as the initial sedative were identified, and outcomes were analyzed using inverse probability of treatment weighting to balance baseline characteristics. Outcomes included in-hospital mortality, need for mechanical ventilation, time on ventilator, ICU length of stay (LOS), and hospital LOS. Subgroup analyses compared phenobarbital with short-acting (lorazepam) and long-acting (diazepam, chlordiazepoxide) benzodiazepines.

RESULTS:

Among 763 phenobarbital-treated and 2,863 benzodiazepine-treated patients, in-hospital mortality was similar (4.5% vs. 5%; odds ratio 0.88, 95% CI 0.64-1.21). Phenobarbital was associated with reduced mechanical ventilation (32.7% vs. 39.3%; odds ratio 0.82, 95% CI 0.74-0.91), and shorter ICU LOS (3.6 vs. 4.1 days; p = 0.02) with comparable hospital LOS. When stratified by benzodiazepine type, benefits were driven by improved outcomes vs. short-acting benzodiazepines (lower mortality, ventilation, and LOS). In patients with decompensated cirrhosis or MELD-Na >14, phenobarbital demonstrated similar mortality (19% vs. 18.9%) and comparable ICU and ventilatory outcomes.

CONCLUSIONS:

In this first large cohort of patients with severe liver disease, phenobarbital showed comparable mortality, respiratory, and ICU outcomes to benzodiazepines in ALD patients with severe alcohol withdrawal. These results support phenobarbital as a viable alternative in this high-risk population, warranting prospective trials to validate the findings.

IMPACT AND IMPLICATIONS:

This is the first large study to evaluate phenobarbital vs. benzodiazepines for severe alcohol withdrawal specifically in patients with alcohol-associated liver disease, a population often excluded from prior research. This study provides important evidence showing that phenobarbital yields comparable respiratory and mortality outcomes to benzodiazepines in critically ill patients with alcohol-associated liver disease. These findings are important for hepatologists, intensivists, and hospital clinicians who face therapeutic uncertainty and safety concerns regarding benzodiazepine use in this group. Establishing phenobarbital as a viable alternative could help inform future clinical guidelines and support safer, evidence-based management of withdrawal in patients with advanced liver disease.

01 Mar 2026·CNS DRUGS

Safety and Efficacy of Monoamine Oxidase Inhibitors in Patients Who Use Psychoactive Substances: Potential Drug Interactions and Substance Use Disorder Treatment Data

Review

Author: Gillman, Peter Kenneth ; Barnett, Brian S ; Rached, Gaëlle ; Nguyen, Christine ; Van den Eynde, Vincent ; Fiani, Dimitri ; Campana, Anna

Monoamine oxidase inhibitors (MAOIs) remain an important option for patients with treatment-resistant depression (TRD) and other psychiatric conditions, despite potentially serious drug-drug interactions and associated dietary tyramine restrictions. However, they are rarely prescribed in patients with comorbid substance use disorders (SUDs) due to concerns about potential drug interactions and limited research in these populations. This narrative review investigates the use of MAOIs in patients who use psychoactive substances, exploring potential interactions while summarizing the relatively scant literature on using MAOIs as treatments for SUDs. It synthesizes data from 219 peer-reviewed publications investigating MAOI/psychoactive substance interactions or the use of MAOIs to treat SUDs or psychiatric conditions in patients with comorbid SUDs, including 20 randomized controlled trials, 18 non-randomized interventional trials, 32 observational studies/case series, 56 case reports, 85 preclinical studies, and 8 reviews, with publication years spanning from 1955 to 2025. Data from 28 non-peer-reviewed user-submitted reports from drug use/harm reduction forums are also included. Suspected cases of serotonin toxicity have been reported for MAOIs in combination with amphetamine, dextromethorphan, 3,4-methylenedioxymethamphetamine (MDMA), meperidine (pethidine), methadone, and tramadol. Hypertensive urgency/emergency has been reported for MAOIs in combination with alcohol (varieties containing significant amounts of tyramine), amphetamine, cocaine, dextroamphetamine, khat, methamphetamine, and psilocybin mushrooms. Other notable adverse events associated with MAOIs in combination with psychoactive substances include agitation (4-bromo-2,5-dimethoxyphenethylamine [2C-B] 5-methoxy-N,N-dimethyltryptamine [5-Meo-DMT]), N,N-dimethyltryptamine [DMT]), delirium/confusion (DMT, propoxyphene, and tramadol), edema (chlordiazepoxide), intracranial hemorrhage (amphetamine, khat, and methamphetamine), mania/psychosis (DMT), rhabdomyolysis (5-MeO-DMT, DMT, and propoxyphene), and sedation/stupor/loss of consciousness (amobarbital, amphetamine, cocaine, dextroamphetamine, and propoxyphene). Fatalities have been reported for MAOIs in combination with 5-MeO-DMT, amphetamine, dextroamphetamine, dextromethorphan (in overdose), MDMA, methamphetamine, meperidine, and tramadol (in overdose). Based on our findings, some substances, such as alcoholic beverages containing significant tyramine quantities (uncommon today), amphetamines, opioids with significant serotonergic reuptake inhibition, and some hallucinogens such as the empathogen/entactogen MDMA, can pose potentially fatal risks in combination with MAOIs. However, MAOI treatment of patients who use alcoholic beverages low in tyramine, caffeine, cannabis, nicotine, sedatives, some (primarily classic) hallucinogens, and some other substances can likely be appropriately managed with careful monitoring, although psychoactive substance dose and route of administration are important safety considerations. While there was initially hope MAOIs might effectively treat some SUDs, there are no robust human data to support their efficacy in this context. Given growing levels of substance use and an increasing number of novel illicit compounds being produced, more research on MAOI safety in patients with psychiatric conditions and comorbid psychoactive substance use/misuse is essential to determining their appropriateness in this complex patient population.

News (Medical) associated with Chlordiazepoxide

23 Aug 2024

·pharma.economictimes.indiatimes.com

Govt bans 156 medicines including antibiotics, painkillers, multivitamins: Here is the full list

New Delhi: In a significant move aimed at safeguarding public health, the Indian government has banned 156 fixed-dose combination (FDC) drugs, including a variety of antibiotics, painkillers, multivitamins, and medications for treating fever and hypertension. This decision marks the largest crackdown on FDCs since 2016, when 344 such drugs were prohibited. The Union Ministry of Health and Family Welfare issued a gazette notification on Thursday, officially prohibiting the manufacture, sale, and distribution of the banned FDCs. The ban was based on the recommendations of an expert panel that reviewed a total of 324 FDCs. Impact on Pharmaceutical Industry The banned FDCs include popular combinations such as mefenamic acid and paracetamol injections, commonly used for pain relief and fever, and omeprazole magnesium with dicyclomine HCl, used to treat abdominal pain. The ban is expected to impact major pharmaceutical companies, including Sun Pharmaceuticals, Cipla, Dr. Reddy's Laboratories, Torrent Pharmaceuticals, and Alkem Laboratories. Fixed Dose Combinations Drug Banned List Here is a table listing all 156 banned Fixed Dose Combinations (FDCs) SN Fixed Dose Combination (FDC) 1 Amylase + Protease + Glucoamylase + Pectinase + Alpha Galactosidase + Lactase + Beta-Gluconase + Cellulase + Lipase + Bromelain + Xylanase + Hemicellulase + Malt diastase + Invertase + Papain 2 Antimony Potassium Tartrate + Dried Ferrous Sulphate 3 Benfotiamine + Silymarin + L-Ornithine L-aspartate + Sodium Selenite + Folic acid + Pyridoxine hydrochloride 4 Bismuth Ammonium Citrate + Papain 5 Cyproheptadine HCl + Thiamine HCl + Riboflavine + Pyridoxine HCl + Niacinamide 6 Cyproheptadine Hydrochloride + Tricholine Citrate + Thiamine Hydrochloride + Riboflavine + Pyridoxine Hydrochloride 7 Rabeprazole Sodium (As enteric coated tablet) + Clidinium Bromide + Dicyclomine HCl + Chlordiazepoxide 8 Fungal Diastase + Papain + Nux vomica Tincture + Cardamom Tincture + Casein Hydrolysed + Alcohol 9 Mefenamic Acid + Paracetamol Injection 10 Omeprazole Magnesium + Dicyclomine HCl 11 S-adenosyl methionine + Metadoxine + Ursodeoxycholicacid BP + L-Methylfolate Calcium eq. to L- Methylfolate + Choline bitartratee + Silymarin + L-ornithine Laspartate + Inositol + Taurine 12 Silymarin + Thiamine Mononitrate + Riboflavin + Pyridoxine HCl + Niacinamide + Calcium pantothenate + Vitamin B12 13 Silymarin + Pyridoxine HCl + Cyanocobalamin + Niacinamide + Folic Acid 14 Silymarin + Vitamin B6 + Vitamin B12 + Niacinamide + Folic acid + Tricholine Citrate 15 Sodium Citrate + Citric Acid Monohydrate Flavored with Cardamom Oil, Caraway Oil, Cinnamon Oil, Clove Oil, Ginger Oil + Alcohol 16 Sucralfate + Acelofenac 17 Sucralfate + Domperidone + Dimethicone 18 Sucralfate + Domperidone 19 Tincture Ipecacuanha + Tincture Urgenia + Camphorated Opium Tincture + Aromatic Spirit of Ammonia + Chloroform + Alcohol 20 Ursodeoxycholic Acid + Metformin HCl 21 Weak Ginger tincture + Aromatic Spirit of Ammonia + Peppermint Spirit + Chloroform + Sodium Bicarbonate + Compound Cardamom + Alcohol 22 Sucralfate + Pantoprazole Sodium + Zinc Gluconate + Light Magnesium Carbonate 23 Aloe + Vitamin E Soap 24 Povidone Iodine+ Metronidazole + Aloe 25 Azelaic acid + Tea Tree Oil + Salicylic acid + Allantoin + Zinc oxide + Aloe vera + Jojoba oil + Vitamin E + Soap noodles 26 Azithromycin + Adapalene 27 Calamine + Aloes + Allantoin 28 Calamine + Diphenhydramine Hydrochloride + Aloe + Glycerine + Camphor 29 Chlorphenesin + Zinc oxide + Starch 30 Clindamycin Phosphate + Zinc acetate 31 Gamma Benzene Hexachloride + Benzocaine 32 Glucosamine hydrochloride + Diacerein + Menthol + Camphor + Capsaicin 33 Hydroxyquinone 2.0%w/w + Octyl Methoxycinnamate 5.0% w/w + Oxybenzone 30 % w/w 34 Ketoconazole +Zinc Pyrithione +D-Panthenol +Tea Tree Oil +Aloes 35 Ketoconazole +Aloe vera+ Vitamin A Acetate 36 Ketoconazole +Aloes + ZPTO 37 Kojic Acid +Arbutin +Octinoxate +Vitamin E + Mulberry 38 Lornoxicam +capsaicin +menthol+ camphor 39 Lornoxicam + Thiocolchicoside +Oleum Lini +Menthol + Methyl salicylate 40 Menthol + Aloe vera Topical Spray 41 Menthol +Lignocaine HCl +Aloe vera gel +Clotrimazole +Diphenhydramine 42 Miconazole nitrate + Gentamicin + Fluocinolone Acetonide +Zinc Sulphate 43 Miconazole +Tinidazole 44 Minoxidil +Aminexil+ Alcohol 45 Minoxidil +Azelaic acid + saw palmetto 46 Minoxidil +Aminexil 47 Pine Bark extract+ Kojic acid +Sodium Ascorbyl Phosphate 48 Povidone Iodine +Tinidazole +Zinc sulphate 49 Povidone Iodine + Ornidazole + Dexpanthenol 50 Salicyclic acid +Aloe vera+ Allantoin +D-Panthenol 51 Silver sulphadiazine +Chlorhexidine Gluconate solution +Allantoin + Aloe vera gel +Vitamin E acetate 52 Sodium salicylate + Zinc gluconate + Pyridoxine HCl 53 Tetracycline + Colistin Sulphate 54 Clomiphene +Ubidecarenone 55 Combikit of Clomiphene Citrate + Estradiol Valerate 56 Flavoxate HCl +Ofloxacin 57 Clomiphene Citrate +N-Acetylcysteine 58 Primerose Oil +Cod liver oil 59 Sildenafil Citrate +Papaverine +L-Arginine 60 Tranexamic acid +Mefenamic acid + Vitamin K1 61 Divalproex Sodium +Oxcarbazepine 62 Divalproex Sodium + Levetiracitam 63 Ergotamine tartrate +Caffeine + Paracetamol +Prochlorperazine maleate 64 Piracetam + Ginkgo biloba extracts + Vinpocetin 65 Ginkgo biloba + methylcobalamin 66 Ginkgo biloba + methylcobalamin + Alpha lipoic acid +Pyridoxine HCl 67 Ginseng Extract +Dried extract of Ginkgo Biloba 68 Meclizine HCl+ Paracetamol + Caffeine 69 Nicergoline + Vinpocetine 70 Gamma Linolenic Acid + Methylcobalamin 71 Beclomethasone Dipropionate + Neomycin Sulphate + Clotrimazole + Lignocaine HCl 72 Boric acid+ Phenylephrine HCl + Naphazoline Nitrate + Menthol + Camphor 73 Naphazoline HCl + Chlorpheniramine Maleate + Zinc Sulphate + Hydroxy Propyl Methyl Cellulose 74 Chlorpheniramine Maleate + Naphazoline HCl + Zinc Sulphate + Sodium Chloride + Hydroxy Propyl Methyl Cellulose 75 Chlorpheniramine Maleate + Naphazoline HCl + Hydroxy Propyl Methyl Cellulose 76 Chlorpheniramine Maleate + Sodium Chloride + Boric Acid + Tetrahydrozoline HCl 77 Chlorpheniramine Maleate + Phenylephrine HCl + Antipyrine 78 Ketorolac Tromethamine + Chlorpheniramine Maleate + Phenylephrine HCl + Hydroxy Propyl Methyl Cellulose 79 Ketorolac Tromethamine + Flurometholone 80 Naphazoline HCl + Zinc Sulphate + Boric Acid + Sodium Chloride+ Chlorpheniramine Maleate 81 Naphazoline HCl + Hydroxy Propyl Methyl Cellulose + Boric Acid + Borax + Menthol + Camphor 82 Naphazoline HCl + Hydroxy Propyl Methyl Cellulose + Chlorpheniramine Maleate SN Fixed Dose Combination (FDC) 83 Diphenhydramine Hydrochloride + Phenylephrine Hydrochloride + Menthol + Camphor 84 Diphenhydramine Hydrochloride + Phenylephrine Hydrochloride + Sodium Chloride + Hydroxy Propyl Methyl Cellulose 85 Diphenhydramine Hydrochloride + Phenylephrine Hydrochloride + Sodium Chloride + Methylparaben 86 Methenamine + Sodium Benzoate + Benzyl Alcohol 87 Paracetamol + Phenylephrine Hydrochloride + Chlorpheniramine Maleate 88 Paracetamol + Phenylephrine Hydrochloride + Chlorpheniramine Maleate + Caffeine 89 Propoxyphene + Chlorpheniramine Maleate 90 Propoxyphene + Phenylephrine Hydrochloride + Chlorpheniramine Maleate 91 Propoxyphene + Diphenhydramine Hydrochloride + Phenylephrine Hydrochloride 92 Sodium Benzoate + Sodium Citrate + Citric Acid 93 Vitamin A Palmitate + Vitamin C + Vitamin E + Vitamin B6 + Vitamin B12 94 Vitamin A Palmitate + Vitamin C + Vitamin E + Niacinamide 95 Vitamin B6 + Vitamin B12 + Vitamin C 96 Vitamin B6 + Vitamin B12 + Niacinamide 97 Vitamin B12 + Vitamin B6 + Vitamin C + Folic Acid 98 Vitamin B12 + Vitamin B6 + Niacinamide + Folic Acid 99 Vitamin C + Vitamin E + Vitamin A + Niacinamide 100 Vitamin D + Calcium + Magnesium 101 Vitamin D + Calcium + Magnesium + Zinc 102 Calcium + Vitamin D + Vitamin K 103 Calcium + Vitamin D + Magnesium + Zinc 104 Calcium + Vitamin D + Vitamin K + Magnesium 105 Calcium + Vitamin D + Vitamin K + Magnesium + Zinc 106 Vitamin E + Vitamin A + Vitamin C + Niacinamide 107 Vitamin E + Vitamin A + Vitamin C + Folic Acid 108 Vitamin E + Vitamin A + Vitamin C + Biotin 109 Vitamin E + Vitamin A + Vitamin C + Vitamin B12 110 Vitamin E + Vitamin C + Folic Acid 111 Vitamin E + Vitamin C + Biotin 112 Vitamin E + Vitamin C + Vitamin B12 113 Vitamin E + Vitamin C + Zinc 114 Calcium + Vitamin D + Omega-3 Fatty Acids 115 Calcium + Vitamin D + Omega-3 Fatty Acids + Vitamin K 116 Calcium + Vitamin D + Omega-3 Fatty Acids + Vitamin K + Magnesium 117 Calcium + Vitamin D + Omega-3 Fatty Acids + Vitamin K + Zinc 118 Vitamin A + Vitamin C + Vitamin E + Beta-Carotene 119 Vitamin A + Vitamin C + Vitamin E + Beta-Carotene + Zinc 120 Vitamin C + Vitamin E + Beta-Carotene 121 Vitamin C + Vitamin E + Beta-Carotene + Zinc 122 Vitamin C + Vitamin E + Selenium 123 Vitamin D + Calcium + Vitamin K + Omega-3 Fatty Acids 124 Vitamin D + Calcium + Vitamin K + Omega-3 Fatty Acids + Magnesium 125 Vitamin D + Calcium + Vitamin K + Omega-3 Fatty Acids + Zinc 126 Vitamin D + Calcium + Vitamin K + Omega-3 Fatty Acids + Biotin 127 Vitamin D + Calcium + Omega-3 Fatty Acids + Vitamin K + Selenium 128 Vitamin E + Vitamin A + Vitamin C + Zinc 129 Vitamin E + Vitamin A + Vitamin C + Selenium 130 Vitamin E + Vitamin A + Vitamin C + Biotin 131 Vitamin E + Vitamin A + Vitamin C + Folic Acid + Niacinamide 132 Vitamin E + Vitamin C + Beta-Carotene + Zinc 133 Vitamin C + Vitamin E + Biotin + Folic Acid 134 Vitamin C + Vitamin E + Beta-Carotene + Folic Acid 135 Vitamin C + Vitamin E + Beta-Carotene + Selenium 136 Vitamin E + Vitamin C + Beta-Carotene + Biotin 137 Vitamin D + Calcium + Omega-3 Fatty Acids + Vitamin K + Biotin 138 Vitamin D + Calcium + Omega-3 Fatty Acids + Vitamin K + Selenium 139 Vitamin D + Calcium + Omega-3 Fatty Acids + Vitamin K + Vitamin B12 140 Vitamin D + Calcium + Omega-3 Fatty Acids + Vitamin K + Vitamin B6 141 Vitamin D + Calcium + Omega-3 Fatty Acids + Vitamin K + Folate 142 Calcium + Vitamin D + Magnesium + Vitamin K + Omega-3 Fatty Acids 143 Calcium + Vitamin D + Magnesium + Vitamin K + Biotin 144 Calcium + Vitamin D + Magnesium + Vitamin K + Selenium 145 Calcium + Vitamin D + Magnesium + Vitamin K + Vitamin B12 146 Calcium + Vitamin D + Magnesium + Vitamin K + Folate 147 Calcium + Vitamin D + Vitamin K + Omega-3 Fatty Acids + Vitamin B6 148 Calcium + Vitamin D + Vitamin K + Omega-3 Fatty Acids + Vitamin B12 149 Calcium + Vitamin D + Vitamin K + Omega-3 Fatty Acids + Folic Acid 150 Calcium + Vitamin D + Vitamin K + Omega-3 Fatty Acids + Biotin 151 Calcium + Vitamin D + Vitamin K + Omega-3 Fatty Acids + Selenium 152 Vitamin A + Vitamin C + Vitamin E + Omega-3 Fatty Acids 153 Vitamin A + Vitamin C + Vitamin E + Omega-3 Fatty Acids + Zinc 154 Vitamin A + Vitamin C + Vitamin E + Omega-3 Fatty Acids + Biotin 155 Vitamin A + Vitamin C + Vitamin E + Omega-3 Fatty Acids + Selenium 156 Vitamin A + Vitamin C + Vitamin E + Omega-3 Fatty Acids + Vitamin B12

Drug Approval

27 Jul 2022

·endpts.com

Warning letter issued to New Jersey generics manufacturer over quality control issues

A generics manufacturer has received a warning letter from the FDA over several issues surrounding supervision and quality control. Bi-Coastal Pharma International’s drug manufacturing facility in Shrewsbury, New Jersey initially received a Form 483 earlier this year. But according to another letter dated June 30, the FDA has found some flagrant issues with the company’s responses. The letter initially stated that Bi-Coastal had failed to establish and follow written procedures around the handling of written and oral complaints for drug products. The FDA found that the company had not investigated a complaint about an adverse reaction after taking Chlordiazepoxide Hydrochloride (HCl) and Clidinium Bromide (Br), 5 mg/2.5 mg, which was discovered and distributed by the company. No investigation was initiated to evaluate the manufacturing and packaging of Chlordiazepoxide HCl and Clidinium Br, according to the letter. In addition, the FDA said Bi-Coastal didn’t attempt to obtain samples of the drug or more information from the complainant. Bi-Coastal said that its CMO was no longer in business and was unable to share the complaint with the CMO for further investigation. However, the FDA argues that as the product owner, Bi-Coastal is still responsible for ensuring control over outsourced activities. While the company said it would revise the process for handling complaints, the FDA found the response inadequate. Regulators also accused Bi-Coastal of failing to write down and follow procedures. No details of its interim controls were supplied to the FDA, or an evaluation of its agreements with the CMOs. The FDA also found that the QA manager lacked experience and training in quality assurance and the sciences, despite being responsible for overseeing CMOs and batch release. The manager was also “unaware of GMP stability testing and process validation requirements for drug products manufactured by CMOs.” In response, Bi-Coastal said its vice president and general manager will help ensure proper adherence to procedures while it finds a new manager. “This response is inadequate. You failed to provide evidence showing this individual is qualified to provide oversight of CGMP activities. In addition, you have not provided details as to how you will ensure the new quality assurance manager will have the appropriate combination of training, education, and experience to perform the job adequately,” the letter said. The company had 15 days from June 30 to respond to the FDA to fix these issues. If the issues remain unaddressed, the FDA may withhold the issuance of export certificates, or the approval of new applications or supplements until the company complies.

Generic Drug

100 Deals associated with Chlordiazepoxide

External Link

KEGG	Wiki	ATC	Drug Bank
D00267	Chlordiazepoxide	N05BA02	DB00475

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Epilepsy	China	Hubei Huazhong Pharmaceutical Co. Ltd.	01 Jan 1981
Sleep Initiation and Maintenance Disorders	China	Hubei Huazhong Pharmaceutical Co. Ltd.	01 Jan 1981
Mood Disorders	Japan	Takeda Pharmaceutical Co., Ltd.	01 Jun 1961
Muscle Spasticity	Japan	Maruishi Pharmaceutical Co., Ltd.	14 Mar 1961
Depressive Disorder	Japan	T’s Pharma Co., Ltd.	28 Feb 1961
Neurotic Disorders	Japan	T’s Pharma Co., Ltd.	28 Feb 1961
Anxiety Disorders	United States	Bausch Health Cos., Inc.	24 Feb 1960

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