Approvable letter news from FiercePharma
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ALSO NOTED: Valeant to halve its workforce; Pharma testing mobile marketing waters;
> Valeant Pharmaceuticals said it will cut 130 jobs in the U.S. in Mexico, on top of the 1,250 positions set to go when the company sells off its European subsidiaries. Read more...
ALSO NOTED: Merck's Cordaptive fails to get U.S. approval; Medtronic sub faces FDA-imposed outage;
> In a blow to Merck's 2008 plans, the cholesterol candidate Cordaptive failed to get the FDA's OK; in a "not approvable letter," the agency asked for more data. Read more...
ALSO NOTED: Appeals court votes for FDA approval shield; Suicides rose as depression treatment fell;
> A federal appeals court backed the drug industry's arguments that it should be insulated from lawsuits over FDA-approved products, ruling 2-1 that antidepressant makers GlaxoSmithKline and Read more...
FDA nixes long-acting Zyprexa
Who at the FDA really cares what those advisory committees think? The FDA has Read more...
FDA shoots down Mevacor OTC
It's official: Merck's off-patent statin drug Mevacor can't go over-the-counter. About a month after Read more...
Sun copycat to cut $500M off Wyeth sales
Wyeth shouldn't be facing generic competition for Effexor XR until 2010. It already fought that battle in court, prevailing over patent challenges in 2005. But Sun Pharmaceuticals figured out how to Read more...
Indevus gets approvable letter
Indevus got a preliminary FDA nod on Valstar, its bladder cancer therapy. The drug had been taken off the market in 2002 because of "impurities" in the original formula; since then, the Read more...
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