This article is more than 5 years old. Information may no longer be current.
FDA approves generic enoxaparin
Click Here to Manage Email Alerts
The FDA has approved a generic version of enoxaparin sodium, an anticoagulant used to prevent deep vein thrombosis.
Originally approved in 1993, enoxaparin (Lovenox, Sanofi-Aventis) is a form of heparin given by injection. The prescribing information for the brand-name drug and the new generic version includes a boxed warning that use of the drug in patients undergoing spinal/epidural anesthesia or spinal puncture increases the risk for spinal or epidural bleeding and hematoma, which may cause long-term or permanent paralysis.
For a generic drug to be approved by the FDA, the manufacturer, Sandoz Inc. of Broomfield, Colo., had to demonstrate that it contained the same active ingredient as the brand-name drug. The process can be more complex for a natural product such as enoxaparin.
“Before approving generic enoxaparin sodium injection, we expected, among other things, a series of sophisticated analytical tests and a study in healthy volunteers to assure that the drug would be as safe and effective as the brand-name product,” said Keith Webber, PhD, deputy director of the FDA’s Office of Pharmaceutical Science.
The generic product has been approved in the following strengths: 30 mg/0.3 mL, 40 mg/0.4 mL, 60 mg/0.6 mL, 80 mg/0.8 mL, 100 mg/mL, 120 mg/0.8 mL and 150 mg/mL.
Information about the marketing and availability of this generic drug can be obtained from the manufacturer. Before the approval, the FDA received a citizen petition questioning the approval criteria for generic enoxaparin sodium injection. After carefully reviewing the petition, the agency determined that current scientific evidence, precedent and the FDA’s legal authority establish a sound basis for the approval of generic enoxaparin sodium injection.
Follow HemOncToday.com
on Twitter.