Word: fda
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Dates: during 2000-2009
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Your doctor will know whether he or she received doses from the lots in question. The Centers for Disease Control (CDC) and the Food and Drug Administration (FDA) are contacting all health care providers and asking them to return unused vaccines from these lots...
That expansion was partly in preparation for the launch of a potential blockbuster drug called Zelnorm, aimed at irritable bowel syndrome, for which there are few treatments. But the FDA, expressing concern about Zelnorm's side effects, rejected the application, asking for more data. In the short term, says Morgan Stanley analyst Duncan Moore, Novartis' prospects for robust growth depend heavily on the FDA's reversing its ruling on Zelnorm and approving an anti-inflammatory drug named Prexige, which Novartis plans to submit to the agency toward the end of this year...
Vasella points out that bringing a drug to market can take a decade and that the glacial pace of drug development and FDA approval puts companies under tremendous pressure to extend exclusive rights to their drugs. Better, he suggests, to grant a drug market exclusivity for a limited period that starts only after it obtains FDA approval...
...guidance of president Susan Arnold, who previously headed the company's beauty and personal-care division--a group that added more than $20 billion in sales to P&G's top line last year--P&G invested an additional $1.5 million in the project after the product got FDA over-the-counter clearance. Days later, P&G also signed a joint agreement to develop and distribute home-use antiaging devices with Syneron Medical Ltd., a $150 million medical-device maker in Yokneam, Israel, known for its patented "elos" technology, which combines bipolar radio frequency and light sources to combat...
...Sherif, president and CEO of Ageless Beauty, a beauty company based in Valencia, Calif., that markets Marvel-Minis, three separate light-based devices that are claimed to tackle acne (blue light), wrinkles (red) and sun spots (green). The brush-shaped tools ($225 each), which have not yet gotten the FDA's nod, went on sale at Nordstrom in April. "We ran out of stock in the first 30 days," boasts Sherif. "And I got phone calls from [potential partners and buyers] after just 20 days of being in business. Can you believe it?" Dee Rodriguez, president of Coastal Products International...