Alembic Pharmaceuticals Limited has announced receiving tentative approval from the United States Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% (OTC). This approval positions the drug as therapeutically equivalent to Pataday Once Daily Relief Ophthalmic Solution by Alcon Laboratories.
The ophthalmic solution is designed to offer temporary relief from itchy eyes caused by allergens such as pollen, ragweed, grass, animal hair, and dander. This over-the-counter (OTC) product is aligned with stringent USFDA standards, ensuring its therapeutic efficacy and safety.
As per IQVIA data, Olopatadine Hydrochloride Ophthalmic Solution commands an estimated market size of USD 22 million for the 12 months ending September 2024. This highlights a significant opportunity in the OTC ophthalmic care segment.
Share price of Alembic Pharmaceuticals is trading higher at ₹1,100.65 up by 0.14%. The stock price has surged by 45% in CY2024.
With this recent addition, Alembic Pharmaceuticals now boasts a total of 219 ANDA approvals from the USFDA, including 192 final approvals and 27 tentative ones. This achievement underscores the company’s robust research and development capabilities and its commitment to global healthcare.
Established in 1907, Alembic Pharmaceuticals Limited is a vertically integrated pharmaceutical company headquartered in India. Renowned for its expertise in branded generics, the company serves global markets with a diverse range of pharmaceutical products. Its cutting-edge research and manufacturing facilities are accredited by regulatory authorities, including the USFDA.
Disclaimer: This blog has been written exclusively for educational purposes. The securities mentioned are only examples and not recommendations. It is based on several secondary sources on the internet and is subject to changes. Please consult an expert before making related decisions.
Published on: Dec 4, 2024, 2:45 PM IST
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