FDA Holds Back Approval of Teva’s Generic Lovenox
February 15, 2011
The FDA has dealt Teva Pharmaceutical Industries a setback in its effort to win approval of a generic version of Sanofi-Aventis’ blood thinner Lovenox, telling the company it needs more information before it can approve its application. The agency’s Office of Generic Drugs (OGD) sent Teva a minor deficiency letter, in which it asked the company to respond to “a short list of questions,” Teva said Jan. 25, adding that it intends to respond to the questions in the near future. A spokeswoman for Teva declined to elaborate on what information the agency is seeking from the company.