Last Updated on October 11, 2024 by The Health Master
Glenmark Pharmaceuticals has received a second tentative approval by the United States Food & Drug Administration (USFDA) for Saxagliptin Tablets, 2.5 mg and 5 mg.
Saxagliptin Tablets is the generic version of Onglyza Tablets, 2.5 mg and 5 mg, of AstraZeneca AB.
Glenmark’s first tentative approval letter for Saxagliptin Tablets, 2.5 mg and 5 mg was received on June 12, 2017.
According to IQVIA sales data for the 12-month period ending December 2022, the Onglyza Tablets, 2.5 mg and 5 mg market achieved annual sales of approximately $122.3 million*.
Glenmark’s current portfolio consists of 179 products authorised for distribution in the US marketplace and 46 ANDAs pending approval with the USFDA.
USFDA gives tentative nod for these two generic drugs
USFDA gives nod for Aflibercept injection to treat infants with prematurity issue
USFDA gives nod for generic Lenalidomide capsules
USFDA gives approval for Glycopyrrolate Injection USP
USFDA gives approval for Diclofenac Sodium Topical Solution USP
USFDA approves this anemia drug for patients on dialysis
NPPA proposes ceiling price of 26 more scheduled formulations
USFDA issues Form 483 with 8 observations to Cipla for Pithampur facility
Medical Device alert: USFDA classifies recall of these devices as most serious
Govt asks Pharma Industry to go for QR code instead of SMS Code
E-pharmacies under radar: Govt to initiate stern action
New guidelines for Blood Centres / Banks on bulk transfers: Maharashtra
FDA Haryana: Medical store sealed, drugs being sold at prices higher than MRP
Dissolution test: Importance in Pharma Industry
Updated list of Medical Device Testing Laboratories (MDTLs)
Latest Notifications regarding Pharmaceuticals
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon:
