Drug Approval | January 16, 2025
Alembic announces USFDA final approval for Brexpiprazole Tablets
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Rexulti Tablets
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Rexulti Tablets
The fixed-dose combination of Abacavir 60 mg/Dolutegravir 5 mg/Lamivudine 30 mg tablets for oral suspension is a once-daily single-pill regimen
The approved product has an estimated market size of US$ 106 million for the twelve months ending October 2024, according to IQVIA
Sitagliptin and Metformin Hydrochloride Tablets, 50 mg/500 mg and 50 mg/1000 mg are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
The product will be marketed by Dr. Reddy's
This product will be manufactured at Lupin’s Nagpur facility in India
Fludrocortisone acetate tablets will be produced at the Group's manufacturing site at Moraiya, Ahmedabad
Granules now has a total of 67 ANDA approvals from the USFDA
Paliperidone extended-release tablets will be produced at the Group’s manufacturing site at SEZ, Ahmedabad
Cetirizine is used for relief of symptoms of hay fever and other allergic conditions
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