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Yaz Approved for PMDD Symptoms

[ Price : $8.95]

FDA approves Berlex Yaz oral contraceptive for treating PMDD emotional and physical symptoms.

Another Consent Decree $ans Penalty

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Although FDA has fought in court to retain its authority to seek financial remedies (disgorgement of profits and restitution), rec...

Panel Backs Tighter Potency Specs on Levothyroxine

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An FDA joint advisory panel recommends tighter potency specifications for levothyroxine sodium products.

Novartis Issues Gleevec Heart Warning

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Novartis says its Gleevec may be associated with increased risk of decreased heart function.

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites ALK-Abello, IVF Michigan, Berkline, Medtronic Vascular, and Optimal Wellness Cen...

Bar Code Label Guidance Out

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CDER and CBER issue a guidance with answers to 24 typical questions on implementing bar codes on drug and biologics labels.

FDA OKs Axcans H. Pylori Eradicator

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FDA approves Axcan Pharmas NDA for Pylera, indicated for eradicating ulcer-causing Helicobacter pylori.

FDA Regains Lead on Personal Reimportation Enforcement

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FDA resumes its lead enforcement role on personal drug reimportation involving mailed prescription drugs coming from Canadian phar...

Medtronic Plans for Drug Stent Approval in 2007

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Medtronic says it expects to gain FDA approval for its Endeavor drug-eluting coronary stent in 2007.

UK Drug Industry Group Suspends Merck Unit

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The Association of the British Pharmaceutical Industry suspends Mercks UK business unit for violating its drug promotion code of p...