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(26 Feb 2025, 19:15)

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


Caplin Steriles (Caplin), a subsidiary company of Caplin Point Laboratories 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 IQVIA (IMS Health), Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution had US sales of approximately $242 million for the 12-month period ending December 2024.


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