FDA Approvals - Ranbaxy Receives Tentative Approval From Us FDA To Market Risperidone
Ranbaxy Receives Tentative Approval From Us FDA To Market Risperidone Oral Solution (Medical News Today)
Ranbaxy Laboratories Limited (RLL) announced today that the Company has received tentative approval from the U.S. Food and Drug Administration (US FDA) to manufacture and market Risperidone Oral Solution, 1 mg/mL. Risperdal (risperidone) is indicated for the treatment of schizophrenia. Total annual market sales for risperidone oral solution were $66 million (IMS - MAT: March 2006). [click link
Mylan sees no further pain-patch approvals from FDA this year (Market Watch)
SAN FRANCISCO (MarketWatch) -- Mylan Laboratories Inc. no longer expects any additional generic versions of Ortho-McNeil's Duragesic pain patch to gain regulatory approval during fiscal 2007, the drugmaker said Monday.
No more skin patches for 2007, but Mylan EPS in place (bizjournals.com via Yahoo! Finance)
Mylan Laboratories Inc. said it "no longer anticipates additional generic transdermal fentanyl approvals," for the remainder of its fiscal 2007, but said it won't revise its earnings projections.