 "US FDA grants approval to Strides Shasun’s antibacterial drug metronidazole")
Bangalore-based Strides Shasun Limited yesterday received approval from the US Food & Drug Administration (FDA) for anti-bacterial drug metronidazole tablet (250 mg and 500 mg). The product received approval in 17 months under the new GDUFA regime. Strides Shasun is expected to launch the product immediately.
Metronidazole tablet is indicated for treatment of wide variety of infections caused by particular types of bacteria and parasites.
The US market for metronidazole tablets 250 mg and 500 mg is approximately $ 50 million, according to IMS data. The product will be manufactured at the company’s oral dosage facility at Bangalore and marketed by Strides in the US market.
