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Archive for October, 2007

FDA announces revisions to three ED drug labels

Wednesday, October 31st, 2007

The FDA has approved labeling changes for erectile dysfunction drugs in the class that includes tadalafil (Cialis), vardenafil (Levitra), and sildenafil citrate (Viagra), to display more prominently the potential risk of sudden hearing loss and to guide consumers on what to do if they experience sudden problems with their hearing. (Source: UrologyTimes – Sexual Dysfunction)

MI in Young Women Induced by Appetite Suppressants

Wednesday, October 31st, 2007

Malaysian doctors report two cases of MI in women under 40, which they say appear to be linked to use of the appetite suppressants phentermine and sibutramine. Heartwire (Source: Medscape Cardiology Headlines)

Hypnosis Effective with Smokers, Study Says

Wednesday, October 31st, 2007

A new study concludes that hypnotherapy is more effective than nicotine replacement therapy (NRT) in getting hospitalized patients to quit smoking after discharge. (Source: Alcohol, Tobacco and Other Drugs News)

Wednesday, October 31st, 2007

Nature Reviews Drug Discovery 6, 860 (2007). doi:10.1038/nrd2458 Pfizer’s Neurontin back in courtThe US Court of Appeals for the Federal Circuit has overturned an earlier district court decision that ruled that several generics manufacturers do not infringe on Pfizer’s patent (US 6,054,482) for Neurontin (gabapentin), a widely used drug for treating seizures (Source: Nature Reviews Drug Discovery)

Barr Receives Tentative Approval For A Generic Version Of Mirapex(R) Tablets, 0.125mg, 0.25mg, 0.5mg, 1mg And 1.5mg

Wednesday, October 31st, 2007

Barr Pharmaceuticals, Inc. (NYSE: BRL) announced that its subsidiary, Barr Laboratories, Inc., has received tentative approval from the U.S. Food and Drug Administration (FDA) for its generic version of Boehringer Ingelheim Pharmaceuticals, Inc.’s Mirapex(R) (Pramipexole Dihydrochloride) Tablets, 0.125mg, 0.25mg, 0.5mg, 1mg and 1.5mg. The Company believes that it is the first to file an Abbreviated New Drug Application (ANDA) with a paragraph IV certification for Mirapex. [click link for full article] (Source: Parkinson’s Disease News From Medical News Today)

FDA announces revisions to three ED drug labels

Tuesday, October 30th, 2007

The FDA has approved labeling changes for erectile dysfunction drugs in the class that includes tadalafil (Cialis), vardenafil (Levitra), and sildenafil citrate (Viagra), to display more prominently the potential risk of sudden hearing loss and to guide consumers on what to do if they experience sudden problems with their hearing. (Source: UrologyTimes – Sexual Dysfunction)

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The US FDA has approved changes to the US labels of the erectile dysfunction therapies Cialis [tadalafil], Levitra [vardenafil] and Viagra [sildenafil]

Tuesday, October 30th, 2007

(Source: Reactions)

Celexa/Lexapro MDL Plaintiffs Ordered To Produce Update On Computer Imaging Process

Monday, October 29th, 2007

ST. LOUIS – Plaintiffs in the Celexa and Lexapro multidistrict litigation were ordered Oct. 19 to provide defendants with an update by Nov. 20 on the status of the imaging process for computers that were used by decedents within one year of their deaths (In re: Celexa and Lexapro Products Liability Litigation, MDL Docket No. 1736, E.D. Mo.; See November 2006, Page 16). Full story on lexis.com (Source: LexisNexis® Mealey’s™ Antidepressant Drugs Legal News)

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Hypnotherapy achieves high post-hospital smoking cessation rates

Sunday, October 28th, 2007

Hospital patients who receive hypnotherapy after discharge are more likely to quit smoking than patients who use other smoking cessation techniques, preliminary study findings suggest. (Source: MedWire News – Respiratory)

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FDA warns about ’stay awake drug’ Provigil

Sunday, October 28th, 2007

The U.S. Food and Drug Administration (FDA) has issued a warning in connection with the drug Provigil because of dangerous side effects. (Source: News-Medical News Feed)

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