Neuroscience
From the company's press release:
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Anthony H. Risser | neuroscience | neuropsychology | brain
- Fda: Insomnia Drug Approval
From the FDA: For Immediate Release: Nov. 23, 2011 FDA approves first insomnia drug for middle-of-the-night waking followed by difficulty returning to sleep [snippet] The U.S. Food and Drug Administration today approved Intermezzo (zolpidem tartrate sublingual...
- Fda Approves Invega (paliperidone)
An FDA Press Release: FOR IMMEDIATE RELEASE P06-208 December 20, 2006 Media Inquiries: Press Office, 301-827-6242 Consumer Inquiries: 888-INFO-FDA FDA Approves New Drug for Schizophrenia The Food and Drug Administration (FDA) today approved Invega (paliperidone)...
- Business World: New Insomnia Meds, Including Takeda's Ramelteon (rozerem, Tak-375)
A brief overview to some of the anticipated insomnia medications trending from this year to next, this is from a recent Reuters report, as published on the International Herald Tribune website:New entries shake insomnia market's slumber Reuters ...
- Business World: Guilford Pharm's Gliadel
A company press release regarding a treatment for brain tumors: Guilford Pharmaceuticals Announces Orphan Drug Designation for GLIADEL(R) Wafer; Market Exclusivity for GLIADEL(R) Extends Until 2010 BALTIMORE, Sept. 27 /PRNewswire-FirstCall/ -- Guilford...
- Cymbalta And Diabetic Peripheral Neuropathy
The Food and Drug Administration (FDA) today announced its approval of this medication as a treatment for a common neurological complication of diabetes. From the press release: FDA Approves Drug for Neuropathic Pain Associated With Diabetes Today...
Neuroscience
Business World: Takeda's Ramelteon (Rozerem, TAK-375)
From the company's press release:
Takeda Receives Approval from the Food and Drug Administration for ROZEREM™ (ramelteon)[ ... Read the full press release ... ]
Osaka, Japan, July 23, 2005 - Takeda Pharmaceutical Company Limited (“Takeda”) today announced that its US based global research and development organization, Takeda Global Research & Development Center Inc. has received an approval from the U.S. Food and Drug Administration (FDA) for ROZEREM (ramelteon), 8 mg tablets for the treatment of insomnia. ROZEREM is the first and only prescription sleep medication not designated as a controlled substance by the U.S. Drug Enforcement Administration (DEA). Takeda Pharmaceuticals North America, Inc. will market ROZEREM in the US market.
ROZEREM has a unique therapeutic mechanism of action as compared to existing insomnia treatments because it selectively targets two receptors in the brain's suprachiasmatic nucleus (SCN). The SCN is known as the body's "master clock" because it regulates 24-hour or "circadian" rhythms, including the sleep-wake cycle.
Takeda discovered ramelteon in 1996, and the ROZEREM New Drug Application (NDA), submitted in September 2004, was based on data collected from Takeda’s extensive clinical research program, including recently completed clinical studies with more than 4,200 patients.
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Anthony H. Risser | neuroscience | neuropsychology | brain
- Fda: Insomnia Drug Approval
From the FDA: For Immediate Release: Nov. 23, 2011 FDA approves first insomnia drug for middle-of-the-night waking followed by difficulty returning to sleep [snippet] The U.S. Food and Drug Administration today approved Intermezzo (zolpidem tartrate sublingual...
- Fda Approves Invega (paliperidone)
An FDA Press Release: FOR IMMEDIATE RELEASE P06-208 December 20, 2006 Media Inquiries: Press Office, 301-827-6242 Consumer Inquiries: 888-INFO-FDA FDA Approves New Drug for Schizophrenia The Food and Drug Administration (FDA) today approved Invega (paliperidone)...
- Business World: New Insomnia Meds, Including Takeda's Ramelteon (rozerem, Tak-375)
A brief overview to some of the anticipated insomnia medications trending from this year to next, this is from a recent Reuters report, as published on the International Herald Tribune website:New entries shake insomnia market's slumber Reuters ...
- Business World: Guilford Pharm's Gliadel
A company press release regarding a treatment for brain tumors: Guilford Pharmaceuticals Announces Orphan Drug Designation for GLIADEL(R) Wafer; Market Exclusivity for GLIADEL(R) Extends Until 2010 BALTIMORE, Sept. 27 /PRNewswire-FirstCall/ -- Guilford...
- Cymbalta And Diabetic Peripheral Neuropathy
The Food and Drug Administration (FDA) today announced its approval of this medication as a treatment for a common neurological complication of diabetes. From the press release: FDA Approves Drug for Neuropathic Pain Associated With Diabetes Today...