Caplin Steriles gets USFDA approval for Tranexamic Acid Injection

Caplin Steriles, Wholly Owned Subsidiary of Caplin Point Laboratories 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, 1000 mg/10ml (100 mg/mL) vial, a generic therapeutic equivalent version of Cyklokapron Injection, 100 mg/ml, of Pharmacia & Upjohn Company.

Tranexamic Acid Injection is administered in patients with hemophilia for short-term use (two to eight days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.

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