Alembic Pharma gets USFDA nod for Pramipexole Dihydrochloride extended-release tablets
The approval from the United States Food and Drug Administration (USFDA) is for the company's abbreviated new drug application (ANDA) for Pramipexole Dihydrochloride extended-release tablets, in the strengths of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3 mg, 3.75 mg, and 4.5 mg, Alembic Pharmaceuticals said in a filing to BSE.
New Delhi: Drug firm Alembic Pharmaceuticals said it has received approval from the US health regulator for Pramipexole Dihydrochloride extended-release tablets used for the treatment of Parkinson's disease.
The approval from the United States Food and Drug Administration (USFDA) is for the company's abbreviated new drug application (ANDA) for Pramipexole Dihydrochloride extended-release tablets, in the strengths of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3 mg, 3.75 mg, and 4.5 mg, Alembic Pharmaceuticals said in a filing to BSE.
The approved product is a therapeutic equivalent to the reference listed drug product (RLD) Mirapex ER tablets, of Boehringer Ingelheim Pharmaceuticals Inc.
The company currently has a total of 84 ANDA approvals (71 final approvals and 13 tentative approvals) from USFDA, it added.
Alembic Pharmaceuticals Ltd. is an Indian multinational pharmaceutical company headquartered in Vadodara city of Gujarat. Alembic Pharmaceuticals Ltd. is involved in the manufacture of pharmaceutical products, pharmaceutical substances and intermediates.
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