Dr Reddy's gets USFDA nod for Ondansetron

Dr Reddy's Laboratories Ltd today got the final approval for Ondansetron Hydrochloride, the generic equivalent of the blockbuster drug `Zofran', from the US Food and Drug Administration (USFDA), as well as a 6-month marketing exclusivity.

The Hyderabad based pharma major announced that the USFDA has granted final approval for its Abbreviated New Drug Application (ANDA) for Ondansetron Hydrochloride Tablets in dosages of 4mg, 8mg, 16mg and 24mg.

Marketing exclusivity

As the first company to file an ANDA containing a paragraph IV certification for this product, the company has also been awarded a 180-day period of marketing exclusivity, a press release from the company said.

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