Caplin Labs gets USFDA nod for injection to prevent excessive blood loss

Caplin Point Laboratories on Thursday said its subsidiary Caplin Steriles has received final approval US health regulator for Tranexamic Acid Injection, used to prevent excessive blood loss from major trauma.

Caplin Steriles... has been granted final approval from the United States Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Tranexamic Acid injection USP in the strengths 1000mg/10ml (100mg/mL) vial, Caplin Point Laboratories said in a BSE filing.

The approved product is a generic therapeutic equivalent version of Cyklokapron injection, 100 mg/ml of Pharmacia and Upjohn Company.

Caplin Point Laboratories said Tranexamic Acid Injection is administered in patients with hemophilia for short-term use to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.

Quoting IQVIA (IMS Health) data, Caplin Point Laboratories said, Tranexamic Acid had US sales data of approximately USD 30 million for the 12 month period ending March 2019.

Caplin Steriles said it has developed and filed 11 ANDAs on its own and with partners, with 5 approvals so far.

"The company is also working on a portfolio of 35 simple and complex injectable and ophthalmic products, to be filed over the next four years," it added.

Shares of Caplin Point Laboratories were trading 3.42 per cent higher at Rs 428 apiece on BSE.