Caplin Steriles gets USFDA approval for eye drops

Caplin Point Laboratories announced that its subsidiary, Caplin Steriles Limited, has received final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution (Eye drops), 0.2%/0.5% in 5mL, 10mL and 15mL fill presentation. The product is a generic therapeutic equivalent of Abbvie Inc.'s COMBIGAN, indicated for reducing elevated intraocular pressure in glaucoma or ocular hypertension patients. According to IQVIA (IMS Health), the brand product had US sales of approximately $242 million for the 12-month period ending December 2024. Caplin Steriles now has 34 ANDA approvals in the US, and is developing portfolio of complex injectable and ophthalmic products.