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Glenmark Receives FDA Approval for Anti-Malaria Tablets

by Kathy Jones on  January 19, 2011 at 9:02 PM Drug News   - G J E 4
The US Food and Drug Administration (FDA) has given its nod for the marketing of anti-malaria tablets, atovaquone and proguanil hydrochloride in the country, Glenmark Pharmaceuticals said.
 Glenmark Receives FDA Approval for Anti-Malaria Tablets
Glenmark Receives FDA Approval for Anti-Malaria Tablets
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The drug marker revealed that its US subsidiary, Glenmark Generics, has received the permission from the FDA to market the anti-malarial tablets in the US and added that the company will be marketing it under 250mg and 100 mg variants.

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The approval comes after the company said that it had settled a lawsuit with GlaxoSmithKline in April 2010 which gives it the royalty license to market atovaquone/proguanil 250mg/100mg tablets, which are generic variants of GSK's Malarone tablets.

"Glenmark believes that it is entitled to 180 days of exclusivity with respect to its atovaquone/proguanil 250mg/100mg tablets as the first generic to file an ANDA for the product", Glenmark said in a statement.



Source: Medindia
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