Caplin Steriles Limited, a subsidiary of Caplin Point Laboratories Limited, has achieved a milestone with the final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Ofloxacin Ophthalmic Solution USP 0.3 percent (eye drops). 

This approval marks the introduction of a generic therapeutic equivalent version of OCUFLOX Ophthalmic Solution by Allergan Inc.

Ofloxacin Ophthalmic Solution USP 0.3 percent is targeted for the treatment of eye infections, specifically those arising from conjunctivitis and corneal ulcers. Its approval opens avenues for patients seeking affordable yet effective solutions for these conditions.

Data from IQVIATM (IMS Health) indicates that Ofloxacin Ophthalmic Solution USP 0.3 percent generated approximately USD 52 million in sales within the United States for the 12-month period ending December 2023. 

With this approval, Caplin Steriles Limited strengthens its position in the pharmaceutical industry by expanding its portfolio of high-quality generic medications. The availability of generic Ofloxacin Ophthalmic Solution USP 0.3 percent offers healthcare providers and patients access to a cost-effective treatment option without compromising on quality.