Home Brand News Alembic Pharmaceuticals receives USFDA Approval for Pramipexole Dihydrochloride

Alembic Pharmaceuticals receives USFDA Approval for Pramipexole Dihydrochloride

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Extended-Release Tablets, 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3 mg, 3.75 mg, and 4.5
mg.

Alembic Pharmaceuticals Limited today announced that the Company has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application
(ANDA) Pramipexole Dihydrochloride Extended-Release Tablets, 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3 mg, 3.75 mg, and 4.5 mg.

The approved ANDA is therapeutically equivalent to the  reference listed drug product (RLD) Mirapex ER Tablets, 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3 mg, 3.75 mg, and 4.5 mg, of Boehringer lngelheim Pharmaceuticals, Inc. (Boehringer).
Pramipexole dihydrochloride extended-release tablets are indicated for the treatment of Parkinson’s disease.
Pramipexole Dihydrochloride Extended-Release Tablets, 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3 mg, 3.75 mg, and 4.5 mg have an estimated market size of US$ 38.6 million for twelve months ending December 2017 according to IQVIA.
Alembic has a cumulative total of 84 ANDA approvals (71 final approvals and 13 tentative approvals) from USFDA.

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