Caplin Point Laboratories’ arm gets USFDA’s final nod for Timolol Maleate Ophthalmic Solution

08 Aug 2024 Evaluate

Caplin Point Laboratories’ subsidiary -- Caplin Steriles (Caplin)  has been granted final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Timolol Maleate Ophthalmic Solution USP, 0.5% (Eye drops), a generic therapeutic equivalent version of the Reference Listed Drug (RLD) TIMOPTIC, from Bausch and Lomb Inc. 

Timolol Maleate Ophthalmic Solution USP, 0.5% (Eye drops) is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open angle glaucoma. According to IQVIA (IMS Health), Timolol Maleate Ophthalmic Solution USP, 0.5% had US sales of around $45 million for the 12-month period ending June 2024. 

Caplin Point Laboratories is engaged mainly in manufacturing a wide range of Ointments, Creams and other External application preparations in addition to the regular segments of pharmaceutical formulations.


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