Alembic Pharma receives USFDA approval for ophthalmic drug

Alembic Pharmaceuticals Limited received approval from the USFDA for azelastine hydrochloride ophthalmic solution, 0.05%, the company informed on Friday.

The US Food & Drug Administration (USFDA) gave its nod for the Abbreviated New Drug Application (ANDA) azelastine hydrochloride ophthalmic solution, 0.05%. The approved ANDA is therapeutically equivalent to the US reference listed drug (RLD), Optivar ophthalmic solution, 0.05%, manufactured by Mylan Specialty L.P. (Mylan). Azelastine hydrochloride ophthalmic solution 0.05% is indicated for the treatment of itching of the eye, associated with allergic conjunctivitis.

Azelastine hydrochloride ophthalmic solution, 0.05%, had an estimated market size of US$ 8.5 million for 12-months ending December 2018, according to IQVIA.

Alembic now has a total of 89 ANDA approvals (76 final approvals and 13 tentative approvals) from the USFDA.

Alembic Pharmaceuticals Limited is one of the leading research and development pharma company. It is principally engaged in the manufacturing and selling of Active Pharmaceutical Ingredients and Formulations.

On Friday, at 11:55 hours, the stock of Alembic Pharma was trading at per share price of Rs. 537.00, down by Rs. 2.95 or 0.26 per cent on BSE.