Caplin Steriles receives USFDA final approval for ANDA Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution

Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution is indicated for the reduction of elevated intraocular pressure

Caplin Steriles Limited (Caplin), a Subsidiary Company of Caplin Point Laboratories Limited, has been granted final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution (Eye drops), 0.2%/0.5% in 5mL, 10mL and 15mL fill presentation, a generic therapeutic equivalent version of the Reference Listed Drug (RLD) COMBIGAN, by Abbvie Inc.

Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution is indicated for the reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension. According to IQVIATM (IMS Health), Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution had US sales of approximately $242 million for the 12-month period ending December 2024.