Alembic Gets US Approval for Parkinson's Drug | CORPORATE ETHOS

Alembic Gets US Approval for Parkinson’s Drug

By: | January 3, 2019
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Alembic Pharmaceuticals Limited has 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 tentativeapprovals) from USFDA.