Apotex Corp. has announced that the FDA has given final approval to its Abbreviated New Drug Application (ANDA) for paroxetine HCl tablets. The drug is rated “AB,” which means that the FDA considers it therapeutically equivalent to its brand name counterpart, Paxil®, manufactured by GlaxoSmithKline (GSK). The drug will be available in strengths of 10, 20, 30, and 40 mg.
Apotex was the first generic drug manufacturer to challenge GSK’s patents covering Canadian Paxil® and the first to gain FDA approval for an AB-rated generic version of the popular drug.
Apotex submitted its ANDA for paroxetine HCl in March 1998 and continues to be in litigation with GSK regarding generic versions of several products.
GSK’s patent for Paxil® expires in 2006. In March 2003, it was ruled that its patent in the U.S. covering the hemi-hydrate form of Paxil® is valid but not infringed by Apotex’s rival product. Apotex plans to launch its generic version by 2005 at the latest.