FDA nod for Orchid’s anti-bacterial drug

Orchid Chemicals has received the US Drug Regulator's approval for anti-bacterial tablets

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The approval is for Gemifloxacin Mesylate tablets in the strength of 320 mg

Chennai-based Orchid Chemicals and Pharmaceuticals has received approval from the United States Food and Drug Administration (US FDA) for generic anti-bacterial Gemifloxacin Mesylate tablets.

'The company has received approval from the United States Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Gemifloxacin Mesylate tablets in the strength of 320 mg,' the company said in a filing to BSE.

The approval is with 180 days of generic drug exclusivity, it added.

 

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