Alembic Pharmaceuticals has received an approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2%. The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Pataday Ophthalmic Solution, 0.2%, of Novartis Pharmaceuticals Corporation. Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% is indicated for the treatment of ocular itching associated with allergic conjunctivitis.
Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% have an estimated market size of $62 million for twelve months ending December 2018 according to IQVIA.
Alembic now has a total of 93 ANDA approvals (81 final approvals and 12 tentative approvals) from USFDA.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.
