HMR's Anzemet "Approvable" In USA
Hoechst Marion Roussel has received approvable letters from the US Foodand Drug Administration for the oral and intravenous formulations of Anzemet (dolasetron mesylate). This follows submission of a New Drug Application to the FDA last year (Marketletter April 22, 1996).
Anzemet will be indicated for the prevention of nausea and vomiting in patients undergoing chemotherapy. The intravenous formulation will also be indicated for the prevention and treatment of postoperative nausea and vomiting (PONV), while the oral formulation will be indicated for the prevention of PONV only.
Anzemet is a 5-HT3 receptor antagonist, and will compete with Glaxo Wellcome's Zofran (ondansetron) and SmithKline Beecham's Kytril (granisetron) which are already on the market for the same indications. A spokeswoman for HMR said that although Anzemet did have some differentiating factors from the competitors, the company was still in negotiation with the FDA with regard to final labeling. Anzemet is already approved in the UK, its first market, and Australia.
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