Caplin Steriles gets USFDA approval for Ofloxacin ophthalmic solution
Drug Approval

Caplin Steriles gets USFDA approval for 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

  • By IPP Bureau | April 17, 2024

Caplin Steriles Limited (Caplin), 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), 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.

According to IQVIATM (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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