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Glenmark Pharma gets FDA approval to market generic malaria drug

Glenmark Pharmaceuticals has received US Food and Drug Administration approval for marketing atovaquone amd proguanil hydrochloride tablets to treat malaria.

Glenmark Pharma claims that its malaria drug is a generic version of GlaxoSmithKline (GSK’s) Malarone tablets, and will be marketed in strengths of 250mg and 100 mg.

Glenmark Pharma has resolved its patent litigation case with GSK regarding atovaquone amd proguanil hydrochloride tablets in April 2010.

As per the settlement of the dispute, Glenmark can market and distribute atovaquone/proguanil 250mg/100mg tablets under a royalty-bearing license from GSK in the 3rd quarter of calendar year 2011, or earlier under certain circumstances.