Sun Pharma asks for withdrawal of 28 drug applications
The company said one of its wholly-owned subsidiaries had sought the withdrawal of 28 ANDAs as the drugs were no longer marketed in the US.
Sun Pharmaceuticals informed the BSE on Tuesday one of its subsidiaries had requested the US Food and Drug Administration (USFDA) to withdraw 28 Abbreviated New Drug Applications (ANDAs) as they belonged to older drug products of erstwhile Ranbaxy Laboratories.
"This is to inform you that one of the Company's wholly-owned subsidiaries has voluntarily requested the USFdA to withdraw approval for 28 Abbreviated New Drug Applications (ANDAs). These older drug products belong to erstwhile Ranbaxy Laboratories and are not being marketed in the US since 2008," the notification read.
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 Pharma's shares were trading nearly flat, at Rs 632.00 apiece, down 20 paise from the previous close. The shares had however hit an intraday high of Rs 638.