Navigation Links
FDA Approves First Generic Versions of Ambien for Insomnia

The U.S. Food and Drug Administration (FDA) today approved the first generic versions of Ambien (zolpidem tartrate) immediate-release tablets.// Zolpidem (ZOLE-pi-dem) tartrate is a sedative-hypnotic drug indicated for the short-term treatment of insomnia.

"The FDA’s Office of Generic Drugs ensures that generic drugs are safe and effective for the American public through a rigorous scientific and regulatory process," said Gary J. Buehler, director, Office of Generic Drugs. "This approval offers Americans more alternatives when choosing their prescription drugs."

Zolpidem tartrate tablets in formulations of five milligrams and 10 milligrams are manufactured by multiple generic drug companies in the United States. The following 13 manufacturers have received FDA approval for zolpidem tartrate tablets: Mylan Pharmaceuticals Inc., TEVA Pharmaceuticals USA, Roxane Laboratories Inc., Watson Laboratories Inc., Ranbaxy Laboratories Ltd., Dr. Reddy’s Laboratories Ltd., Apotex Inc., Synthon Pharmaceuticals Inc., Genpharm Inc., Mutual Pharmaceutical Company Inc., Caraco Pharmaceutical Laboratories Ltd., Carlsbad Technology Inc., and Lek Pharmaceuticals.

In March, FDA requested that all manufacturers of sedative-hypnotic drug products, a class of drugs used to induce and/or maintain sleep, strengthen their product labeling to include stronger language concerning potential risks. These risks include severe allergic reactions and complex sleep-related behaviors, which may include sleep-driving. Sleep driving is defined as driving while not fully awake after ingestion of a sedative-hypnotic product, with no memory of the event.

According to the online magazine Drug Topics, in 2006, Ambien was the 13th highest selling brand name drug. The sanofi-aventis (formerly Sanofi-Synthelabo, Inc.) patent for zolpidem tartrate expired on April 21, 2007.

The FDA’s Office of Generic Drugs (OGD) reviews and decides on approval of generic drug applications.

Source: Generef.com
SM
'"/>




Related medicine news :

1. FDA Approves Contraceptive Ring
2. FDA Approves New HIV Drug, Viread
3. FDA Approves Birth Control Skin Patch
4. FDA Approves New Arthritis Drug, Bextra
5. FDA Approves Elidel Cream for Eczema
6. FDA Approves New Anti-Clotting Drug
7. FDA Approves New surgery Treatment for Farsightedness
8. FDA Approves Anti-Cancer Cell Drug - Zevalin
9. FDA Approves Remodulin for Pulmonary Hypertension
10. World Health Organisation Takes a Historic Decision and Approves Treaty to Discourage Smoking
11. World Health Organisation Takes a Historic Decision and Approves Treaty to Discourage Smoking
Post Your Comments:
*Name:
*Comment:
*Email:


(Date:8/18/2017)... ... August 18, 2017 , ... With over 16,000 active patients, ... replacement therapy and integrative medicine, has become a frontrunner for people seeking help ... menopause, andropause, thyroid disorder and adrenal insufficiencies. , Founded in 2003 by ...
(Date:8/18/2017)... ... August 18, 2017 , ... 800response, the leading provider ... announced today the launch of a redesigned corporate website, 800response.com . ... responsive design, and an enhanced search directory for businesses and advertising agencies to ...
(Date:8/18/2017)... ... ... Our Imaginations: The Infinite God”: shows the importance of God in living a happy ... author, Mark Lawrence, born in Michigan, the author has lived in various communities and ... of God is that I have to be more mindful of feminine qualities to ...
(Date:8/18/2017)... ... ... “Prompted By Love”: a love story thrown into doubt by untimely news. “Prompted ... Nettles has devoted her life to ministry since the age of 12 when she ... however, not fulfilled until 2014 when "The Color of Roses" was published. After ...
(Date:8/17/2017)... ... August 17, 2017 , ... Shared ... and considered extremely effective, very effective, or effective by 85% of respondents, according ... NEJM Catalyst Insights Reports are based on surveys of the NEJM Catalyst Insights ...
Breaking Medicine News(10 mins):
(Date:8/17/2017)... LOS ANGELES , Aug. 17, 2017 ... by CBMJ – Canna Broadcast Media, today reveals its leading ... that Isodiol International Inc., a global cannabis innovator specializing in ... platinum sponsor of the conference. MassRoots, Rambridge™ and The Green ... Signal Bay Inc. and Namaste Vapes™ as silver sponsors. ...
(Date:8/15/2017)... Inc., the creator of the drug Truveta for the treatment ... IPO. The United States spends approximately ... prescription epilepsy drug being $450.00-$1200.00 for a one month supply. ... AXIUM PHARMACEUTICALS, INC ... is the fact that Americans spent $42 billion on anxiety medications last ...
(Date:8/10/2017)... 10, 2017  Physical Rehabilitation Network (PRN), acquired the long-standing ... Lakewood, Colorado . The reputable clinic will continue to ... DPT with his staff of four clinicians. Lipkin received his ... brings over 10 years of experience with a strong background ... PT marks the 10th PRN clinic in and around the ...
Breaking Medicine Technology: