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FDA approval for generic antibiotic and arrhythmia drugs Posted 29/01/2016

Indian generics maker Glenmark Pharmaceuticals (Glenmark) has gained approval for a generic antibiotic, linezolid, and tentative approval for its generic arrhythmia drug dronedarone.

The US Food and Drug Administration (FDA) granted final approval for Glenmark’s linezolid tablets at a dose of 600 mg on 21 December 2015. The drug is a therapeutic equivalent of Pfizer’s subsidiary Pharmacia and Upjohn Company’s antibiotic Zyvox (linezolid).

Zyvox is used to treat different types of bacterial infections such as pneumonia, skin infections and infections that are resistant to other antibiotics. According to IMS Health, Zyvox tablets, 600 mg, had sales of approximately US$447.6 million for the 12-month period ending October 2015.

Glenmark also announced on 6 January 2016 that FDA had granted tentative approval for the company’s generic dronedarone tablets at a dosage of 400 mg. The drug is a generic version of arrhythmia drug Multaq (dronedarone), which is made by Sanofi-Aventis.

‘Tentative approval’ means that FDA has concluded that a drug product has met all required quality, safety and efficacy standards, but is not eligible for marketing in the US because of existing patent protections or exclusivities. Glenmark believes it is one of the first companies to have filed a substantially complete abbreviated new drug application (ANDA) containing a Paragraph IV certification for dronedarone and expects to be eligible for 180 days of generics exclusivity upon final FDA approval. Glenmark is involved in a patent litigation in the US District Court for Delaware, wherein Sanofi and Sanofi-Aventis have asserted their patents.

Multaq had sales of approximately US$425.7 million for the 12-month period ending November 2015.

Glenmark Pharma currently has 106 products authorized for distribution in the US and 62 ANDAs pending approval from FDA.

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Source: Glenmark, US FDA

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