Alembic Pharma gets USFDA nod for Pramipexole Dihydrochloride

Pramipexole dihydrochloride extended-release tablets are indicated for the treatment of Parkinson's disease.

Jan 03, 2019 05:01 IST India Infoline News Service

Alembic Pharmaceuticals
Alembic Pharmaceuticals has received approval from the 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.

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 $38.6mn for twelve months ending December 2017, according to IQVIA data.

Alembic has a cumulative total of 84 ANDA approvals (71 final approvals and 13 tentative approvals) from USFDA.

Pramipexole dihydrochloride extended-release tablets are indicated for the treatment of Parkinson's disease.

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).

Alembic Pharmaceuticals Ltd is currently trading at Rs590 up by Rs9 or 1.55% from its previous closing of Rs581 on the BSE. The scrip opened at Rs580 and has touched a high and low of Rs593.35 and Rs580 respectively.

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