Caplin Point Labs gets USFDA nod for anticoagulant injection

New Delhi, Jan 22: Drug firm Caplin Point Laboratories on Friday said its arm Caplin Steriles has received final nod from the US health regulator for its generic anticoagulant Argatroban injection.
Caplin Steriles has been granted final approval from the United States Food and Drug Administration (USFDA) for its abbreviated new drug application for Argatroban injection, 50 mg/50 ml (1 mg/ml), single-dose vial presentation, it said in a filing to BSE.
The product is a generic version of Hikma Pharmaceuticals’ Argatroban injection, it added.
Caplin has received a competitive generic therapy (CGT) grant for this abbreviated new drug application (ANDA) and is eligible for 180 days of CGT exclusivity for the product, the filing said.
“We’re excited to receive our first approval with CGT exclusivity from our pipeline. We will target launching the product within the shortest time possible,” Caplin Point Laboratories Chairman C C Paarthipan said.
According to IQVIA, Argatroban injection had US sales data of approximately USD 18 million for the 12-month period ended September 2020, the filing said.
“Argatroban is used as an anticoagulant for prophylaxis or treatment of thrombosis in patients with heparin-induced thrombocytopenia,” it added.