Alembic Pharmaceuticals receives USFDA Approval for Azelastine Hydrochloride Ophthalmic Solution, 0.05%.

Deepthi | Myequity news | Date : 22-03-2019 11:25:00 IST

Alembic Pharmaceuticals Limited has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Azelastine Hydrochloride Ophthalmic Solution, 0.05%. The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Optivar Ophthalmic Solution, 0.05%, of 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%, has an estimated market size of US$ 8.5 million for twelve months ending December 2018 according to IQVIA.


About Alembic Pharmaceuticals Limited

Alembic Pharmaceuticals Limited, a vertically integrated research and development pharmaceutical company, has been at the forefront of healthcare since 1907. Headquartered in India, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world. Alembic's state of the art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA.


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