Teva receives FDA action letter for generic Lovenox
JERUSALEM — Teva on Tuesday confirmed its receipt of an action letter from the Food and Drug Administration for its generic blood-thinning drug.
The drug maker said the FDA sent a minor deficiency letter, which indicated the regulatory agency completed its review of the abbreviated new drug application for generic Lovenox (enoxaparin sodium) injection, as well as Teva's responses to key questions during the review process. Prior to potential final product approval, Teva also needs to respond to questions posed by the Office of Generic Drugs, which the drug maker said it will answer in the near future.
Lovenox, designed to treat deep vein thrombosis, is made by Sanofi-Aventis.