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by Therapeutic Category
FDA Approvals-Generic Drugs
Lamisil Tablets: FDA Approves First Generic Versions of Lamisil Tablets
Agency also approves over-the-counter terbinafine cream to treat athlete's foot
Date:
07/02/2007
, Publication:
FDA News
, Author:
FDA
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01662.html
Insomnia-FDA Approves First Generic Versions of Ambien (Zolpidem Tartrate) for the Treatment of Insomnia
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.
Date:
04/23/2007
, Publication:
FDA News
, Author:
FDA
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01616.html
Approved Drug-Electronic Orange Book-Search Approved Drug Products-
with Therapeutic Equivalence Evaluations, Current through February 2007
Date:
02/01/2007
, Publication:
FDA
, Author:
FDA
http://www.fda.gov:80/cder/ob/default.htm
Ondansetron-FDA Approves First Generic Ondansetron Tablets, Orally Disintegrating Tablets and Oral Solution
The economic benefits of FDA's generic drug approval program are significant because generic drug products, which are used to fill over 50 percent of all prescriptions...
Date:
12/27/2006
, Publication:
FDA News
, Author:
FDA
http://www.fda.gov/bbs/topics/NEWS/2006/NEW01539.html
Depressive Disorder FDA Approves First Generic Bupropion Hydrochloride Extended-Release Tablets
...approved the first generic version of Wellbutrin XL (Bupropion hydrochloride) Extended-Release Tablets, which are indicated for the treatment of major depressive disorder (MDD).
Date:
12/14/2006
, Publication:
FDA News
, Author:
FDA
http://www.fda.gov/bbs/topics/NEWS/2006/NEW01526.html
Gastroenterology-FDA Approves First Generic Ondansetron Injection
Ondansetron is indicated for the prevention of nausea and vomiting associated with emetogenic cancer chemotherapy (cancer therapy that causes vomiting) and prevention of postoperative nausea and vomiting...
Date:
11/22/2006
, Publication:
FDA News
, Author:
FDA
http://www.fda.gov/bbs/topics/NEWS/2006/NEW01513.html
Therapeutic Equivalence-FDA Approved Drug Products with Therapeutic Equivalence Evaluations
Orange Book
Date:
11/17/2006
, Publication:
FDA-CDER
, Author:
FDA
http://www.fda.gov/cder/orange/default.htm
Women-FDA Approves First Generic Metronidazole
Bacterial vaginosis is a condition in women that is characterized by vaginal discharge and results from an overgrowth of bacteria in the vagina
Date:
11/01/2006
, Publication:
FDA News
, Author:
FDA
http://www.fda.gov/bbs/topics/NEWS/2006/NEW01501.html
Gynecology-FDA Approves First Generic Metronidazole
...approved the first generic version of MetroGel-Vaginal (metronidazole vaginal gel), a treatment for bacterial vaginosis.
Date:
11/01/2006
, Publication:
FDA News
, Author:
FDA
http://www.fda.gov/bbs/topics/NEWS/2006/NEW01501.html
Anti-inflammatory-FDA Approves First Generic Meloxicam
Meloxicam is a widely-used nonsteroidal anti-inflammatory drug (NSAID)
Date:
07/19/2006
, Publication:
FDA News
, Author:
FDA
http://www.fda.gov/bbs/topics/NEWS/2006/NEW01412.html
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