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Granules India gets USFDA nod for sleep aid drug

The approved product is the generic equivalent of Aleve PM tablets of Bayer HealthCare LLC. The US Food and Drug Administration (USFDA) has approved the abbreviated new drug application (ANDA) for Naproxen Sodium and Diphenhydramine Hydrochloride tablets, 220 mg/25 mg (OTC), Granules said in a BSE filing.

PTI | New Delhi | Updated: 25-09-2020 12:22 IST | Created: 25-09-2020 12:14 IST
Granules India gets USFDA nod for sleep aid drug
Representative Image Image Credit: ANI

Drug firm Granules India on Friday said it has received the US health regulator's approval for Naproxen Sodium and Diphenhydramine Hydrochloride tablets, used for relief in occasional sleeplessness associated with minor aches and pains. The approved product is the generic equivalent of Aleve PM tablets of Bayer HealthCare LLC.

The US Food and Drug Administration (USFDA) has approved the abbreviated new drug application (ANDA) for Naproxen Sodium and Diphenhydramine Hydrochloride tablets, 220 mg/25 mg (OTC), Granules said in a BSE filing. Granules now has a total of 31 ANDA approvals from the USFDA (29 Final approvals and 2 tentative approvals).

Shares of Granules India were trading 3.33 per cent higher at Rs 372.60 apiece on BSE.


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