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Articles for Regulatory

Kilitch Healthcare India Recalls Various Eye Drops In US For Safety Concerns

Kilitch Healthcare India is voluntarily recalling the eye drop products listed in the table below to the consumer level with all lots within expiry with expiration dates ranging from November 2023 to September 2025 for all the below-mentioned products

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FDA Expresses Concerns Over Merck's Chronic Cough Drug Efficacy Data, Expert Panel To Review

Reportedly, Merck had submitted additional data after the FDA rejected the drug in January of the previous year

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FDA Approves LetsGetChecked's At-home STI Test

The U.S. Food and Drug Administration (FDA) has granted marketing authorisation to LetsGetChecked for the Simple 2 Test, the first-ever diagnostic test for chlamydia and gonorrhoea with at-home sample collection

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Biocon Biologics Receives MHRA Approval For YESAFILI Biosimilar In The UK

In September, YESAFILI received marketing authorisation approval from the European Commission (EC) for the European Union (EU)

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Lupin Launches Generic Rocuronium Bromide Injection Following U.S. FDA Approval

Rocuronium Bromide Injection had estimated annual sales of USD 54 million in the U.S. according to IQVIA MAT, August 2023

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Lupin Gains Tentative FDA Approval For Generic Canagliflozin & Metformin Tablets

Canagliflozin plays a crucial role in reducing the risk of major adverse cardiovascular events, which encompasses cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke, in adults suffering from type 2 diabetes mellitus with established cardiovascular disease

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Glenmark Pharmaceuticals Receives FDA Approval For Fluphenazine Hydrochloride Tablets

Glenmark’s Fluphenazine Hydrochloride Tablets USP, 1 mg, 2.5 mg, 5 mg, and 10 mg, will be distributed in the U.S. by Glenmark Pharmaceuticals Inc., USA

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FDA Warns Of Hidden Drug Ingredients In Dr Ergin’s SugarMD Glucose Support

FDA laboratory analysis has uncovered that this product contains glyburide and metformin, both of which are active ingredients found in FDA-approved prescription medications designed for the treatment of type 2 diabetes

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