Glenmark gets USFDA's tentative nod for Riluzone
Glenmark Generics, a subsidiary of Glenmark Pharmaceuticals, today said it has received tentative approval from the USFDA for generic version of Sanofi Aventis' neurological disease treatment drug Rilutek.
The US Food and Drugs Administration (USFDA) has given tentative approval for 50 mg tablets of Riluzone, the company said in a statement.
Based on the tentative approval, Glenmark Generics should be able to launch the product upon patent expiry in June 2013, it added.
Rilutek is used for treatment of amyotrophic lateral sclerosis, a nervous system disease that attacks nerve cells and the drug had generated a total sales of $47 million in the 12 months period ended March 2010, as per IMS Health.
Today's approval is the second tentative approval that the company has received this month, while it has got four final approvals in July from the USFDA.
Glenmark's current portfolio comprises 57 products, which could be sold in the US and has 50 abbreviated new drug applications (ANDAs) pending approval.