First generic enoxaparin sodium injection gets FDA nod

Lovenox, an anti-coagulant or blood thinner, is manufactured by the German drug maker Sandoz and Momenta Pharmaceuticals Inc. of Cambridge, Mass.

Lovenox helps prevent deep vein thrombosis, the formation of clot in deep veins particularly in the lower leg or thigh, which can result in pulmonary embolism, a sudden potentially fatal blockage in a lung artery.

Drug pharmacology
The Enoxaparin trusses and quickens the activity of antithrombin III, thus intensifying the inhibition of coagulation factors Xa and IIa. The blood thinning effect of enoxaparin is directly related to its ability to inhibit factor Xa.

"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," Keith Webber, deputy director of the FDA's Office of Pharmaceutical Science said.

The approval criteria
Although Lovenox, the brand-name product enoxaparin sodium injection, is already being marketed in the USA since 1993, seeking a marketing approval for its generic version was difficult.

Lovenox is made from herparin, a naturally-derived mix of sugar molecules derived from pig intestines. Pharmacologically, herparin is too complex to be copied with precision by makers of generic version of the drug.

For a generic version to get marketing approval, the manufacturer needs to show that it contains the same active ingredient as the brand-name product.

"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," Keith Webber, deputy director of the FDA's Office of Pharmaceutical Science said.

The "current scientific evidence, precedent, and FDA's legal authority establish a sound basis for the approval of generic enoxaparin sodium injection," the response issued by the FDA read.

Drug marketing
Like Lovenox, its generic will also come with a boxed warning stating that the use of the drug can be risky in patients undergoing spinal/epidural anesthesia or spinal puncture.

The Lovenox therapy is known to increase the risk of spinal or epidural bleeding and bruising (hematoma), causing long-term or permanent paralysis.

The enoxaparin sodium injection will be available 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.