Alembic Pharmaceuticals Ltd announces USFDA Tentative Approval for Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% (OTC)

Alembic Pharmaceuticals Limited (Alembic) 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.

Shares of Alembic Pharmaceuticals Limited was last trading in BSE at Rs. 1100.40 as compared to the previous close of Rs. 1102.40. The total number of shares traded during the day was 2493 in over 383 trades.

The stock hit an intraday high of Rs. 1112.95 and intraday low of 1096.00. The net turnover during the day was Rs. 2751960.00.

Source : Equity Bulls

Keywords

AlembicPharmaceuticals INE901L01018 USFDA TentativeApproval ANDa OlopatadineHydrochloride OphthalmicSolution OTC