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Home America

Alembic Pharma gets USFDA tentative nod for Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% (OTC)

by Nav Jeevan
5 months ago
in America, Breaking News, Business, Maharashtra, Mumbai, Pharma
Reading Time: 1 min read
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Alembic Pharma gets USFDA tentative nod for Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% (OTC)
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  • Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% (OTC) is used to temporarily relieve itchy eyes due to pollen, ragweed, grass, animal hair and dander

NE HEALTH BUREAU

MUMBAI, DEC 6

Alembic Pharmaceuticals Limited on Wednesday  announced that it has received Tentative Approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% (OTC). The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Pataday Once Daily Relief Ophthalmic Solution, 0.7%, of Alcon Laboratories, Inc. (Alcon) NDA – 206276.

Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% (OTC) is used to temporarily relieve itchy eyes due to pollen, ragweed, grass, animal hair and dander. Refer label for a detailed indication. Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% (OTC) has an estimated market size of US$ 22 million for twelve months ending September 2024 according to IQVIA.

Alembic has a cumulative total of 219 ANDA approvals (192 final approvals and 27 tentative approvals) from USFDA.

Tags: 0.7% (OTC)Alembic PharmaforgetsOlopatadine Hydrochloride Ophthalmic Solution USPtentative nodusfda
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