LONDON and PITTSBURGH, Dec. 4, 2014 /PRNewswire/ — Mylan Inc. (MYL) today announced that its subsidiary Mylan Laboratories Limited has received tentative approval from the U.S. Food and Drug Administration (FDA) for its New Drug Applications (NDAs) for two dosages of abacavir/lamivudine tablets for oral suspension for the treatment of HIV-1 infection in paediatric patients. This is the first version of abacavir/lamivudine with scoring to allow for dose adjustment and is also flavoured. The FDA’s tentative approval through the President’s Emergency Plan for AIDS Relief (PEPFAR) programme means the formulations meet all of the agency’s quality, safety and efficacy standards.
http://finance.yahoo.com/news/mylan-receives-tentative-fda-approval-162900788.html
