US FDA issues action letter for Teva's generic Lovenox; grants orphan status for BioSante vaccine

Global generic drug major Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced yesterday that it has received correspondence from the US Food and Drug Administration regarding the company’s Abbreviated New Drug Application for generic Lovenox (enoxaparin sodium) injection.

Lovenox, an anti-coagulant, is one of French drug major Sanofi-Aventis’ biggest selling drugs, generated 2009 sales of $3.9 billion. The firm has tried to prevent a copy version being approved by the FDA but has failed to do so, as the agency last year cleared a biosimilar version of the drug for Sandoz and Momenta Pharmaceutical (The Pharma Letter July 26, 2010).

The receipt of this action letter, called a Minor Deficiency letter, indicates that the FDA has completed its review of the ANDA including the company's responses to key questions during the review process. Prior to potential final product approval, the Office of Generic Drugs requires responses to a short list of questions, which Teva says it intends to respond to in the near future.