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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...
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.
Read also: Covid-19: FDC launches first Favipiravir Oral Suspension Favenza in India
Ruchika Sharma joined Medical Dialogue as an Desk Editor for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751