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Alembic Pharma receives USFDA Approval for Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2%.

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Capital Market

On 02 May 2019

Alembic Pharmaceuticals announced that the Company has received 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 US$ 62 million for twelve months ending December 2018 according to IQVIA.

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First Published: May 02 2019 | 4:29 PM IST

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