FDA gives nod to first generic enoxaparin for DVT
The FDA has approved the first generic version of enoxaparin sodium injection (Lovenox), an anticoagulant drug used to prevent deep vein thrombosis (DVT).
Approved for use in 1993, Lovenox (Sanofi-Avantis) is made from heparin, a blood-thinning drug whose active ingredient is a naturally-derived complex mixture of sugar molecules.
For a generic drug to be approved by the FDA, the manufacturer must demonstrate it contains the same active ingredient as the brand name drug, according to the agency, which added that 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.
Use of enoxaparin can prevent DVT, a blood clot that forms in a vein deep in the body, especially in the lower leg or thigh—the prevention of which can prevent a pulmonary embolism, the FDA said.
Approval of generic enoxaparin sodium injection was granted to Sandoz Pharmaceuticals of Broomfield, Colo. 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.
The prescribing information for both Lovenox and its generic version includes a boxed warning that use of the drug in patients undergoing spinal/epidural anesthesia or spinal puncture increases the risk of spinal or epidural bleeding and hematoma, which may cause long-term or permanent paralysis.
Approved for use in 1993, Lovenox (Sanofi-Avantis) is made from heparin, a blood-thinning drug whose active ingredient is a naturally-derived complex mixture of sugar molecules.
For a generic drug to be approved by the FDA, the manufacturer must demonstrate it contains the same active ingredient as the brand name drug, according to the agency, which added that 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.
Use of enoxaparin can prevent DVT, a blood clot that forms in a vein deep in the body, especially in the lower leg or thigh—the prevention of which can prevent a pulmonary embolism, the FDA said.
Approval of generic enoxaparin sodium injection was granted to Sandoz Pharmaceuticals of Broomfield, Colo. 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.
The prescribing information for both Lovenox and its generic version includes a boxed warning that use of the drug in patients undergoing spinal/epidural anesthesia or spinal puncture increases the risk of spinal or epidural bleeding and hematoma, which may cause long-term or permanent paralysis.