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Regulatory Bodies & Rulings
Wockhardt antibiotic gets USFDA nod
Our Bureau
Mumbai, Aug. 31
Wockhardt Ltd has received approval from the United States Food and Drug Administration (USFDA) for marketing Cefotaxime sodium (1g) injection in the US market. Wockhardt's US subsidiary, Wockhardt USA Inc, will soon launch the cephalosporin antibiotic in the US, Wockhardt told the Bombay Stock Exchange.
Cefotaxime sodium is the generic version of Sanofi Aventis Claforan injection and is a broad-spectrum antibiotic used in treating a variety of infections. "This is our second approval for sterile cephalosporins, and our sixth approval in the last eight months," said Wockhardt's Chairman Mr Habil Khorakiwala. Cefotaxime sodium is manufactured at the bulk-drug facility at Ankleshwar and the injection is manufactured at the sterile formulation plant at Waluj. Wockhardt currently markets 14 products in the US. Wockhardt shares closed marginally higher at Rs 367 on the BSE.
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