Glenmark gets tentative USFDA nod for epilepsy drug
The company will market the product after receiving a final approval of Lacosamide Oral Solution.
Glenmark Pharmaceuticals said it has received a tentative approval from the US health regulator for its generic version of Vimpat Oral Solution, used in the treatment of epilepsy.
"Glenmark Pharmaceuticals Inc, USA has been granted tentative approval by the US Food and Drug Administration (USFDA) for its Lacosamide Oral solution, 10 Mg/mL, the generic version of Vimpat Oral Solution, 10 Mg/mL of UCB, Inc," it said in a BSE filing.
The company will market this product upon receiving final approval of Lacosamide Oral solution, 10 Mg/mL.
"The patent listed in the Orange Book for Vimpat Oral Solution, 10 Mg/mL is scheduled to expire on March 17, 2022," it added.
According to IMS Health sales data for the 12 months to January 2016, Vimpat has annual sales of around $55.4 million, Glenmark said.
The company's current portfolio consists of 108 products authorised for distribution in the US marketplace and 61 Abbreviated New Drug Applications (ANDA) pending approval with the USFDA.
Glenmark Pharmaceuticals shares were trading at Rs 783.95, down Rs 27.15 or 3.35% lower.