Novartis' Sandoz unit, and partner Momenta Pharmaceuticals announced that the FDA granted approval of

the first generic version of sanofi-aventis' Lovenox.

Novartis said that it will immediately begin shipments of its version of Lovenox, which last year recorded revenues of $2.7 billion.

The FDA explained that the approval process for a generic version of a product such as Lovenox can be "more complex." Deputy director of the FDA’s Office of Pharmaceutical Science, Keith Webber, explained, "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."

In related news, Teva, which is also seeking marketing approval for generic Lovenox, said it believes that it has demonstrated to regulators that its version of Lovenox meets their criteria and that Teva's pending marketing application is approvable. However, Teva shares dropped more than 8 percent over concerns that the FDA may now also approve a generic version of Teva's multiple sclerosis drug Copaxone.
 
IBI analyst Natali Gotlieb said that the FDA's decision may affect Copaxone because both drugs have a complex molecular structure.

Teva stated that "any potential generic version of Copaxone should be evaluated via pre-clinical and full-scale, placebo-controlled clinical trials with measured clinical endpoints in multiple sclerosis patients to establish safety, efficacy and immunogenicity in a real patient population."

However, approval of a generic version of Copaxone may take "a while" as its molecular structure is "more complicated than Lovenox,” added Gotlieb. “Teva is prepared for a decrease in the Copaxone sales and already included that in its guidance.”