USFDA grants nod for Caplin Steriles Ofloxacin Ophthalmic Solution
Ofloxacin Ophthalmic Solution USP 0.3% is indicated for treatment of eye infections caused during the conditions of conjunctivitis and corneal ulcers.;
Chennai: Caplin Steriles Limited, 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) Ofloxacin Ophthalmic Solution USP 0.3% (eye drops).
The product is a generic therapeutic equivalent version of (RLD), OCUFLOX Ophthalmic Solution of Allergan Inc.
Ofloxacin Ophthalmic Solution USP 0.3% is indicated for treatment of eye infections caused during the conditions of conjunctivitis and corneal ulcers. Conjunctivitis, commonly known as "pink eye," is an inflammation or infection of the conjunctiva — the transparent membrane that covers the white part of the eye and lines the inside of the eyelids.
According to IQVIA (IMS Health), Ofloxacin Ophthalmic Solution USP 0.3% had US sales of approximately $52 million for the 12- month period ending December 2023.
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