Dr Reddys, Ranbaxy Receive US FDA Nod For Nefazodone

Hyderabad, New Delhi, Sept 17: | Updated: Sep 18 2003, 05:30am hrs
Dr Reddys Laboratories Ltd (Dr Reddys), has obtained approval from US Food and Drug Administration (US FDA) for Nefazodone Hydrochloride tablets 50, 100, 150, 200 and 250 mg enabling the company to market in the Northern American markets. The product will be marketed through the companys alliance partner, Par Pharmaceuticals, Dr Reddys, in a release, said.

In an yet another development, Ranbaxy Laboratories has also received approval from the US Food and Drug Administration (US FDA) to market Nefazodone Hydrochloride tablets in 50mg, 100mg, 150mg, 200mg and 250mg strengths. Ranbaxy has also launched of Rosuvas, a statin prescribed to reduce cholestrol levels, in the domestic market.

Nefazoxone Hydroch-loride is the AB-rated generic equivalent of Bristol Myers Squibbs Serzone. According to IMS 2002, the product had annual US brand sales of about $261 million.

Meanwhile, Dr Reddys has, so far, obtained approvals for 12 Abbreviated New Drug Applications (ANDAs) and marketed in the US markets, while about 24 ANDAs are awaiting approvals from US FDA. Out of which about 17 ANDAs are patent challenges, eight are first-to-market opportunities. The company has filed about 14 ANDAs during the current fiscal; out of which 10 are paragraph IV.

Rosuvas will compete in the Rs 150 crore statin market growing at 23 per cent annually. The market in India currently has four molecules, Atorvastatin, Simvastatin, Pravastatin and Lovastatin.