Sandoz first to receive FDA approval for Lovenox generic
SILVER SPRING, Md. The Food and Drug Administration has approved the first generic version of a Sanofi-Aventis injected drug used to treat deep vein thrombosis, the agency said Friday.
The FDA approved generic enoxaparin sodium, a version of Sanofi’s Lovenox, developed under a collaboration between Momenta Pharmaceuticals and Sandoz, the generics division of Swiss drug maker Novartis.
Notably, because of the complexity of Lovenox, derived from heparin, the generic version’s approval required a number of complex analytical tests and a clinical study, according to the FDA.
“Sandoz is the first company to launch generic enoxaparin sodium in the U.S., delivering on our strategy of being first-to-market with key products, and underscoring our leadership in differentiated products,” Sandoz global head Jeff George said. “We welcome the FDA decision to approve our enoxaparin application and are now looking forward to significantly increasing patient and payer access to this vital medicine by providing a high-quality, more affordable version.”
Lovenox had U.S. sales of $2.7 billion in 2009, according to Sanofi financial data.