Schering-Plough Drug Gets FDA OK

Updated with recent stock moves.

KENILWORTH, N.J. (TheStreet) -- In a big coup for drug maker Schering-Plough(SGP Quote), the company announced on Friday that the Food and Drug Administration approved the tablet Saphris, which is meant to treat patients with schizophrenia and manic or mixed episodes linked to bipolar disorder.

In a press release, the company noted that the approval marks the first time a psychotropic drug has been given the thumbs up for both issues simultaneously. Schering-Plough also noted that Saphris is expected to hit the U.S. market during the fourth quarter of this year.

Schering-Plough first brought Saphris into the fold after it acquired Organon BioSciences back in November 2007. It also marks the first U.S. approval that's come out of that acquisition.

"Schizophrenia and bipolar I disorder are complex medical conditions that can present clinical challenges for the physician," Dr. Steven G. Potkin, lead author of a Saphris schizophrenia study, said in a statement.

"Having a new FDA-approved treatment such as Saphris is important in these serious conditions because physicians need options to help manage their patients' symptoms," Dr. Roger S. McIntyre, lead author of a Saphris bipolar study, said in a statement.

Schering-Plough shares were slipping 21 cents, or 0.8%, at $26.90 after the opening bell.

Last week, Schering-Plough and Merck(MRK Quote) shareholders approved a $41.1 billion merger.

Merck shares were also down, losing 28 cents, or 0.9%, at $30.70.

In other FDA approval news, on Thursday Amegen's(AMGN Quote) osteoporosis drug denosumab got partial backing from an FDA advisory panel.

-- Reported by Sung Moss in New York