New Delhi: Drug firm Natco Pharma Tuesday said it has submitted an abbreviated new drug application (ANDA) with the US health regulator for the generic version of Bosentan 32 mg tablets for oral suspension. Bosentan 32 mg tablets are sold by Actelion Pharmaceuticals US, Inc under the brand name Tracleer, Natco Pharma said in a filing to the BSE. The company has filed the ANDA with Para IV certification with the US Food and Drug Administration (USFDA), it added.
"Natco believes that its ANDA is possibly the sole first-to-file based on the filing date. We further believe that our ANDA may be eligible for 180 days of marketing exclusivity at the time of potential launch of the product," the company said.
Tracleer is indicated for treatment of pulmonary arterial hypertension, it added.
Shares of Natco Pharma Tuesday closed at Rs 546.95 per scrip on the BSE, up 2.63 per cent from its previous close.