FDC gets USFDA nod for Ofloxacin Otic Solution

Mumbai: Pharma firm FDC Limited has recently announced that the company has received approval from the United States Food and Drug Administration (USFDA) for Ofloxacin Otic Solution, 0.3%.

"This is to inform you that, the Company has been granted ANDA approval by USFDA, for Ofloxacin Otic Solution, 0.3%," the company said in a BSE filing.

An abbreviated new drug application contains data which is submitted to FDA for the review and potential approval of a generic drug product. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, lower cost alternative to the brand-name drug it references.

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