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Drug Major, Sun Pharmaceuticals informed BSE on Tuesday that one of the Company’s wholly-owned subsidiaries has voluntarily requested the USFDA to withdraw approval for 28 Abbreviated New Drug Applications (ANDAs) ) as they belonged to older drug products of erstwhile Ranbaxy Laboratories and are not being marketed in the US since 2008.

According to the USFDA website, “An Abbreviated New Drug Application (ANDA) contains data which when submitted to FDA’s Center for Drug Evaluation and Research, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the American public.”

Sun Pharmaceuticals Industries Ltd is currently trading at Rs 632.1, down by Rs 0.1 or 0.02% from its previous closing of Rs 632.2 on the BSE.
 

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