Gland Pharma Gets USFDA Approval for Olopatadine Ophthalmic Solution
Olopatadine Hydrochloride Ophthalmic Solution is indicated for the treatment of ocular itching associated with allergic conjunctivitis, a common allergic eye condition.
Hyderabad: Gland Pharma Limited has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% (OTC), the company informed stock exchanges on Tuesday.
The approved product is therapeutically equivalent to the reference listed drug Pataday Once Daily Relief, 0.7%, marketed by Alcon Laboratories Inc.
Olopatadine Hydrochloride Ophthalmic Solution is indicated for the treatment of ocular itching associated with allergic conjunctivitis, a common allergic eye condition.
In a regulatory filing made under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015, Gland Pharma stated that the USFDA approval allows the company to market the over-the-counter ophthalmic product in the United States market.
Gland Pharma, established in 1978 and headquartered in Hyderabad, is a generic injectable and ophthalmic-focused pharmaceutical company with operations across more than 60 countries, including the United States, Europe, Canada, Australia, and India. The company primarily operates under a business-to-business (B2B) model and has a strong presence in sterile injectables and ophthalmic formulations.
The company has a diversified portfolio covering vials, ampoules, pre-filled syringes, lyophilized products, oncology injectables, infusions, and ophthalmic solutions, and is also known for pioneering Heparin technology in India.
Gland Pharma stated that the approval aligns with its ongoing strategy to expand its ophthalmic product offerings in regulated markets, particularly the United States.
