FDA APPROVES TEVA'S GENERIC PAXIL
Teva Pharmaceutical has received FDA approval to market a generic version of GlaxoSmithKline's (GSK) blockbuster antidepressant drug Paxil.
Teva received approval to manufacture its version of Paxil (paroxetine HCl) in 10-, 20-, 30- and 40-mg tablets, and said it expects to begin shipping the drug immediately.
Paxil remains a blockbuster for GSK, with sales of $1.93 billion in 2004, even after generic competition drove sales down 39 percent from 2003.
Apotex's launch of a Paxil generic in September 2003 spurred GSK to counter with an authorized generic of Paxil distributed by Par Pharmaceuticals. Par sales of paroxetine totaled $192.5 million in 2003. The FDA's policy of allowing such authorized generics prompted Israel-based Teva to sue the agency in August 2004, arguing such arrangements undercut the generic industry by circumventing the 180-day exclusivity period generic companies get when they are the first to challenge a patent. A federal appeals court ruled against Teva in June.