04-Nov-2026 21:57:48
APLLTDGeneral news
ALEMBIC PHARMA : WINS USFDA FINAL APPROVAL FOR OLOPATADINE OPHTHALMIC SOLUTION
• Received USFDA final approval for ANDA of Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% (OTC) • Approved ANDA is therapeutically equivalent to reference listed drug Pataday Once Daily Relief, 0.7%, of Alcon Laboratories • Indicated for temporary relief of itchy eyes due to pollen, ragweed, grass, animal hair and dander • IQVIA pegs US market size for the product at US$20 million for 12 months ending September 2026 • ANDA developed in collaboration with Orbicular Pharmaceutical Technologies Pvt Ltd • Cumulative ANDA approvals now 248 (229 final and 19 tentative) from USFDA
Alembic Pharmaceuticals Ltd
Open attachment