Alembic Pharma gets USFDA approval for Ophthalmic Solution

Alembic Pharmaceuticals Limited has received the final approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA), Travoprost Ophthalmic Solution USP 0.004 per cent.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Travatan Ophthalmic Solution 0.004 per cent, by Alcon Pharmaceuticals Limited (Alcon). Travoprost Ophthalmic Solution USP 0.004 per cent is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.

Open angle glaucoma is the most common type of glaucoma and usually happens to people over 50 years of age, whereas, ocular hypertension is when the pressure inside the eye (intraocular pressure or IOP) is higher than normal.

Earlier this month, Alembic’s joint venture, Aleor Dermaceuticals Limited, had received tentative approval from the USFDA for its ANDA, Diclofenac Sodium Topical Solution USP 2 per cent w/w.

Alembic has a cumulative total of 110 ANDA approvals (97 final approvals and 13 tentative approvals) from the USFDA.

On Tuesday, during the morning trading session, the stock of Alembic Pharma was up by 1.2 per cent at Rs 547 from its previous close of Rs 540.35 on BSE.