DRL gets US nod for multiple dosages of Ondansetron
Pharmaceutical firm Dr Reddy's Laboratories Ltd has received approval from the US Food and Drug Administration to market Ondansetron Hydrochloride tablets in the US.
By PTI |
MUMBAI: Pharmaceutical firm Dr Reddy's Laboratories Ltd has received approval from the US Food and Drug Administration to market Ondansetron Hydrochloride tablets in the US.
The drug is used to prevent nausea associated with cancer treatment.
The approval is for multiple strengths of Ondansetron Hydrochloride tablets in 4mg, 8mg, 16mg and 24mg. The company's drug is a generic equivalent of GSK's Zofran tablets, DRL informed the Bombay Stock Exchange.
DRL has been awarded a 180-day period of marketing exclusivity and the company would commence the shipment of this product shortly, the statement said.
"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 in the medium term," DRL Vice-Chairman and Chief Executive Officer GV Prasad said in the statement.
Total annualised market sales for the branded drug is estimated at $639 million, the statement said.
The approval follows an order by the United States Court of Appeals denying Apotex's request that the FDA should not approve DRL's generic Zofran products.
The drug is used to prevent nausea associated with cancer treatment.
The approval is for multiple strengths of Ondansetron Hydrochloride tablets in 4mg, 8mg, 16mg and 24mg. The company's drug is a generic equivalent of GSK's Zofran tablets, DRL informed the Bombay Stock Exchange.
DRL has been awarded a 180-day period of marketing exclusivity and the company would commence the shipment of this product shortly, the statement said.
"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 in the medium term," DRL Vice-Chairman and Chief Executive Officer GV Prasad said in the statement.
Total annualised market sales for the branded drug is estimated at $639 million, the statement said.
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The approval follows an order by the United States Court of Appeals denying Apotex's request that the FDA should not approve DRL's generic Zofran products.
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