New Delhi: Dr Reddy's Laboratories Ltd has finally cleared the hurdle for its Abbreviated New Drug Application (ANDA) for Ondansetron Hydrochloride tablets.
On Wednesday, Dr Reddy's Laboratories Ltd said that it has received final approval from the United States Food and Drug Administration (USFDA).
The firm has been awarded a 180-day period of marketing exclusivity. The company will commence the shipment of this product shortly.
Dr Reddy's is the first company to file an ANDA containing a paragraph IV certification for the product.
''We are obviously pleased with the final approval of our generic version of Zofran with 180-days of marketing exclusivity. With six product introductions to date in the current year, we are making good progress in building a sustainable base generics business with potential upsides in the US,'' company Vice-Chairman and Cheif Executive Officer (CEO) GV Prasad told UNI.
Dr Reddy's Ondansetron Hydrochloride Tablets are AB-rated generic equivalent of Glaxo SmithKline's Zofran tablets.
The product helps for the prevention of nausea and vomiting associated with cancer treatment.
As per data available with IMS, the brand product has annual sales of about $639 million.
Comments
0 comment