Dr. Reddy's Laboratories Announces its Launch of Saxagliptin and Metformin Hydrochloride Extended-Release Tablets in the U.S.
Glenmark Pharmaceuticals on Tuesday said it has received approval from the US health regulator to market a generic diabetes drug in the American market. nnnRead more at: nhttps://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/glenmark-gets-usfda-nod-to-market-generic-diabetes-drug/articleshow/102302377.cms?utm_source=contentofinterest&utm_medium=text&utm_campaign=cppst
Glenmark gets USFDA nod to market generic diabetes drug
Drug firm Glenmark said it has received approval from the US health regulator to market a generic medication to treat diabetes in the American market. Glenmark Pharmaceuticals Inc, USA, a unit of the company, has received tentative approval from the US Food & Drug Administration (US FDA) for Saxagliptin Tablets in strengths of 2.5 mg and 5 mg, the Mumbai-based drug maker said in a statement.
Glenmark PharmaceuticalsNSE 0.81 % on Wednesday said it has received tentative approval from the US health regulator for its generic Dapagliflozin and Saxagliptin anti-diabetes tablets. The approval granted by the United States Food and Drug Administration (USFDA) to Glenmark Pharmaceuticals Inc., USA, is for the strength of 10 mg/5 mg tablets, the generic version of Qtern tablets of the same strength of AstraZenecaNSE -0.38 % AB, the company said in a statement.
AstraZeneca Pharma India Limited has announced that it has received import and market permission in Form 45 (Marketing Authorization) from the Drugs Controller General of India (DCGI) for FDC of dapagliflozin 10mg + saxagliptin 5mg film coated tablets.
AstraZeneca, a global, science-led biopharmaceutical company, announced that Qtrilmet (metformin hydrochloride, saxagliptin and dapagliflozin) modified-release tablets have been recommended for marketing authorisation in the European Union for the treatment of adults with type-2 diabetes (T2D).
Xospata leads latest CHMP recommendations
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on Friday recommended the approval of three new medicines, including one orphan product, and recommended extending the indication for eight other drugs.
Teva Pharms USA’s Generic Saxagliptin Receives Tentative Approval in the US