FDA Approves ARGATROBAN Injection (ANDA091665)

The U.S. Food and Drug Administration (FDA) granted approval for Abbreviated New Drug Application (ANDA) number ANDA091665 on June 30, 2014. The approved product is ARGATROBAN injection, a human prescription drug classified as an anti‑coagulant and direct thrombin inhibitor. It is supplied as a 250 mg/2.5 mL (100 mg/mL) injectable solution for intravenous administration. The application was submitted by PH HEALTH, with manufacturing by Par Health USA, LLC. The product is listed under the National Drug Code (NDC) 42023‑182‑89 and 42023‑182‑01.