Caplin Sterils gets USFDA nod for Eye Drop for reduction of elevated intraocular pressure
Chennai: Caplin Steriles Limited, a Subsidiary Company of Caplin Point Laboratories Limited, has been granted final approval by 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.
The product is 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.
Medical Dialogues team had earlier reported that Caplin Steriles had been granted final approval by the USFDA for its ANDA Difluprednate Ophthalmic Emulsion, 0.05% (Eye drops).
Read also: USFDA approves Caplin Steriles eye drop
Caplin Steriles Limited, a Subsidiary of Caplin Point Laboratories Limited, is a fast growing sterile product manufacturing company that is approved by several regulatory agencies such as US FDA, EU-GMP, ANVISA and INVIMA. Caplin Steriles Limited, has developed and filed 46 ANDAs in USA on its own and with partners, with 34 approvals so far. The Company is also working on a portfolio of 40+ simple and complex Injectable and Ophthalmic products, that it intends to file over the next 4 years. The company also has multiple products filed with several approvals in non-US markets such as Mexico, Australia, Canada, South Africa etc.
