Generic Malaria Drug Approval Granted to Glenmark Pharmaceuticals

The United States Food and Drug Administration (FDA) has granted Glenmark Pharmaceuticals final approval to sell a generic version of GlaxoSmithKline (GSK) malaria drug Malarone.

In April 2010, Glenmark settled a patent litigation with GlaxoSmithKline over atovaquone and proguanil hydrochloride 250 milligram/100mg tablets–the generic version of Malarone.

The Indian company can sell the generic tablets under a royalty-bearing license from GlaxoSmithKline in the third quarter of 2011, or earlier under certain circumstances.

KAM

Share