Orphan Medical Xyrem

Xyrem (sodium oxybate) Information | FDA

https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/xyrem-sodium-oxybate-information

Xyrem ( sodium oxybate) Oral Solution is a prescription medicine approved by the U.S. Food and Drug Administration (FDA) with an orphan disease designation to treat …

F.D.A. Approves GHB, a ‘Date Rape’ Drug, for Rare Sleeping …

https://www.nytimes.com/2021/08/12/health/GHB-hypersomnia-sleep-FDA.html

In 1994, the F.D.A. approached a Minnesota drug company called Orphan Medical to investigate GHB as a treatment for narcolepsy. The government gives …

Sodium oxybate - Wikipedia

https://en.wikipedia.org/wiki/Sodium_oxybate

Drug Approval Package: Xyrem (Sodium Oxybate) NDA …

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-196_Xyrem.cfm

Drug Approval Package: Xyrem (Sodium Oxybate) NDA #21-196 Drug Approval Package FDA Home Drugs Drug Approvals and Databases Drugs@FDA …

Orphan Medical Xyrem Central Pharmacy Will List Prescribers …

https://pink.pharmaintelligence.informa.com/PS061022/Orphan-Medical-Xyrem-Central-Pharmacy-Will-List-Prescribers-Under-DEA-Rule

Orphan Medical Xyrem Planned sNDA Will Aim For First-Line Narcolepsy Claim Phase IIIb trial in excessive daytime sleepiness supports expanding label to include all of …

Orphanet: XYREM

https://www.orpha.net/consor/cgi-bin/OC_Exp.php?lng=EN&Expert=65862

Orphanet: XYREM Search Download dataset Homepage Orphan drugs Search Orphan designation Marketing authorization Marketing authorization with orphan designation All …

Orphan Medical’s Xyrem distributor :: Pink Sheet

https://pink.pharmaintelligence.informa.com/PS040380/Orphan-Medicals-Xyrem-distributor

Xyrem was approved July17 (1 Express Scripts Specialty Distribution Services will be sole distributor for Orphan Medical cataplexy therapy Xyrem (sodium …

Maker of Narcolepsy Drug Pleads Guilty in U.S. Case

https://www.nytimes.com/2007/07/14/business/14jazz.html

A subsidiary of Jazz Pharmaceuticals, a maker of the narcolepsy drug Xyrem, pleaded guilty yesterday in federal court in Brooklyn to felony charges of improperly …

ORPHAN MEDICAL, INC., EXHIBIT 99.1 TO FORM 8-K …

https://www.sec.gov/Archives/edgar/data/929548/000089710104001395/orphan043505_ex99-1.htm

The clinical portion of a second trial, EXCEEDS, will be completed in the coming weeks and Orphan Medical expects initial results of the trial by mid-September. EXCEEDS is …

ORPHAN MEDICAL, INC., EXHIBIT 99.1 TO FORM 8-K …

https://www.sec.gov/Archives/edgar/data/929548/000089710104001021/orphan042648_ex99-1.htm

Xyrem is currently the only approved medication for the treatment of cataplexy. Bill Houghton, M.D., Chief Medical & Scientific Officer, Orphan Medical, said, “This was a …