Alembic Pharma gets USFDA approval for Acetazolamide Capsules

Alembic Pharmaceuticals has announced that it has received approval from US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Acetazolamide Extended-Release Capsules, 500 mg.

This ANDA is therapeutically equivalent to the listed drug product Diamox Sequels, 500 mg, of Teva Branded Pharmaceutical Products R&D Inc.

This drug is indicated for adjunctive treatment of chronic simple glaucoma, secondary glaucoma, and pre-operatively in acute angle-closure glaucoma where delay of surgery is desired in order to lower intraocular pressure.

The capsules are also indicated for the prevention or amelioration of symptoms associated with acute mountain sickness despite gradual ascent. The said capsules had an estimated market size of US$ 13.1 million for the 12 months ending December 2018.

Alembic Pharma has a cumulative total of 87 ANDA approvals, of which 74 have final approvals and 13 have tentative approvals from USFDA.

On Tuesday, the stock had closed at Rs. 538.60 per share. On Wednesday, it opened at Rs. 533.90 and made intra-day high of Rs. 545 in the morning trading session.