"This approval offers people more alternatives when choosing their prescription drugs," said Gary J. Buehler, director of the FDA's Office of Generic Drugs.
Zolpidem tartrate tablets in formulations of 5 milligrams and 10 milligrams are manufactured by a variety of generic drug companies in the United States. The following 13 manufacturers have received FDA approval for zolpidem tartrate tablets: Mylan Pharmaceuticals Inc.; TEVA Pharmaceuticals USA; Roxane Laboratories Inc.; Watson Laboratories Inc.; Ranbaxy Laboratories Ltd.; Dr Reddys Laboratories Ltd.; Apotex Inc.; Synthon Pharmaceuticals Inc.; Genpharm Inc.; Mutual Pharmaceutical Company Inc.; Caraco Pharmaceutical Laboratories Ltd.; Carlsbad Technology Inc.; and Lek Pharmaceuticals, the FDA said in a statement.
Warning over side effectsIn March, the FDA requested that all manufacturers of sedative-hypnotic drug products - a class of drugs used to induce and/or maintain sleep - strengthen their product labelling to include stronger warnings about potential risks. Those risks include severe allergic reactions and complex sleep-related behaviours, which may include sleep-driving. Sleep driving is defined as driving while not fully awake after taking a sedative-hypnotic drug, with no memory of the event.
According to the online magazine Drug Topics, in 2006, Ambien was the 13th best selling brand name drug. The sanofi-aventis (formerly Sanofi-Synthelabo, Inc.) patent for zolpidem tartrate expired on April 21, the FDA said. – (HealthDayNews)
Read more:Sleep Centre
April 2007