Orphan Medical responds to FDA
Executive Summary
Orphan Medical's Xyrem (sodium oxybate) will be distributed through a single mail-order pharmacy under a risk management plan proposed in the company's Oct. 9 response to FDA's July 2 "approvable" letter for the narcoleptic cataplexy treatment (1"The Pink Sheet" July 9, p. 18). Orphan's response includes respiratory data from an earlier trial in place of a pre-approval study on respiratory-compromised patients (2"The Pink Sheet" Sept. 3, In Brief). Company's risk management program also calls for a prescription registry and special Xyrem prescribing pads; FDA has six months to act on the response
You may also be interested in...
Orphan Medical Xyrem safety data
Safety data on Orphan Medical's Xyrem (sodium oxybate) in respiratory-compromised patients may be collected post-approval if FDA accepts submission of data on that patient population from an earlier trial, Orphan says. A July 2 "approvable" letter for the narcolepsy treatment indicated that a study would be required before approval. Orphan plans to file the additional data in mid-November and expects a six-month review
Orphan Medical Xyrem FDA Study Request Could Delay Launch Until Mid-2002
Orphan Medical's launch for its narcoleptic cataplexy treatment Xyrem could be delayed until mid-2002 by an FDA request for a study of respiratory-compromised patients.
Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011