HOME >> MEDICINE >> NEWS
FDA approved ROZEREM (ramelteon)

LINCOLNSHIRE, Ill., July 22 Takeda Pharmaceuticals North America, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for ROZEREMTM (ramelteon) 8-mg tablets for the treatment of insomnia characterized by difficulty with sleep onset. The FDA approval allows physicians to prescribe ROZEREM for long-term use in adults.

ROZEREM is the first and only prescription sleep medication that has shown no evidence of abuse and dependence and, as a result, has not been designated as a controlled substance by the U.S. Drug Enforcement Administration (DEA). With the exception of ROZEREM, all other prescription medications indicated for insomnia are classified as Schedule IV controlled substances by the DEA. Additionally, ROZEREM is the first prescription insomnia medication with a new therapeutic mechanism of action in 35 years, and will be available for patients by late September.

"People with insomnia are not only affected by their sleeplessness at night; insomnia's impact is also in how they feel and function the next day," said Thomas Roth, Ph.D., director of the Sleep Disorders and Research Center, Detroit, Mich. "Current therapies often used for insomnia work by broadly inhibiting the activity of neurons in the brain. Ramelteon treats insomnia by specifically affecting the activity of neurons in an area of the brain involved in the sleep-wake process, and has been shown to carry no risks of abuse, withdrawal, or dependency, and negligible risk for next-day 'hangover' effects."

"ROZEREM represents an exciting new option in sleep medicine that we anticipate can help millions of people who live with sleepless nights and sluggish days," said Yasuchika Hasegawa, president and chief operating officer of Takeda. "The approval of ROZEREM marks a major milestone for Takeda as we seek to bring innovative therapies to patients in a variety of therapeutic areas."

ROZEREMTM<
'"/>


22-Jul-2005


Page: 1 2

Related medicine news :

1. Did drug reps encourage doctors to prescribe gabapentin for nonapproved uses?
2. NIH scientists honored for FDA-approved cervical cancer vaccine breakthrough
3. Previously approved drugs may be helpful in fatal pediatric disorder
4. Shires DAYTRANA(TM) transdermal patch approved by FDA for treatment of ADHD
5. Higher dose formulation of FOSRENOL approved to reduce serum phosphorus in esrd patients
6. GlaxoSmithKlines Havrix now approved for use in children aged 12 months and older
7. Cedars-Sinais live donor liver transplant program receives unos-approved designation
8. Many drugs prescribed for chronic insomnia are not approved for that purpose
9. Sildenafil (Viagra) approved for treatment of pulmonary arterial hypertension (PAH) as Revatio
10. ROZEREM (ramelteon) shown to be effective in a first-night-effect model of transient
11. ROZEREM (ramelteon) showed significant reduction in time to fall asleep

Post Your Comments:
*Name:
*Comment:
*Email:


(Date:3/20/2020)... ... 20, 2020 , ... CommunityMed Urgent Care , based in Dallas, has ... room lets patients present online, complete registration paperwork (including the latest COVID screening) provide ... and get signaled that their clean exam room is ready. All of this ...
(Date:3/20/2020)... ... March 21, 2020 , ... The Healthcare ... for a day of live discussion and learning online. Experts will provide helpful ... whistleblower laws, the role of boards, fraud, waste and abuse, and privacy and ...
(Date:3/19/2020)... ... March 19, 2020 , ... For weeks, SignatureCare Emergency Center has been preparing ... week, it announced that while we are still short of some critical safety equipment, ... for our preparedness measures to be complete. , The Houston, TX based company said ...
(Date:3/19/2020)... ... 2020 , ... As confirmed cases of COVID-19 rapidly increase in the United ... global humanitarian organization, Project HOPE’s mandate is always to respond where the need is ... President and CEO of Project HOPE. “We will be supporting America’s health workers as ...
(Date:3/19/2020)... (PRWEB) , ... March 19, 2020 , ... “We wanted ... efficient manner,” said Dr. Viral Patel, Founder of Radish Health. “A reliable at home ... care and peace of mind they need in the comfort of their own home, ...
Breaking Medicine News(10 mins):
(Date:3/20/2020)... ... , ... New Alliance Academy provides its students with the life skills and ... interested in pursuing tertiary studies to achieve their goal. One of the most frequently ... a good chance of progressing into college. , New Alliance Academy is proud to ...
(Date:3/19/2020)... SILVER SPRING, Md. (PRWEB) , ... March 19, ... ... Tufts Medical Center in Boston; Cleveland Clinic in Cleveland; ... Jewish Health in Denver have received accreditation as PHA Centers of Comprehensive ...
(Date:3/16/2020)... (PRWEB) , ... March 16, 2020 , ... In the ... telemedicine and messaging platform, today announced it is ramping efforts to help the containment ... engagement solutions that integrates with any practice management or EMR system. , “Our ...
Breaking Medicine Technology:
Cached News: