Pharmaceutical Business review

US court grants plea to prevent sale of Enoxaparin by Watson, Amphastar

Enoxaparin, a generic equivalent to Sanofi-aventis’ Lovenox is a low molecular weight heparin used to treat deep vein thrombosis and prophylaxis in unstable angina and non-Q-wave myocardial infarction.

The US FDA has approved Amphastar’s Abbreviated New Drug Application (ANDA) for Enoxaparin Sodium Injection in the 30mg/mL, 40mg/mL, 60mg/mL, 80mg/mL,100mg/mL, 120mg/mL, 150mg/mL and 300mg/mL strengths.

The sole right to distribute Amphastar’s Enoxaparin in the US retail pharmacy channel is held by Watson.