Exact(2)
The Food and Drug Administration must now weigh the panel's recommendation that it expand approval of Celebrex.
Last year, when Allergan asked the F.D.A. to expand approval to the not-so-obese (essentially doubling the potential patient pool), the request was based on a clinical trial of only 149 patients who had lap bands for one to two years.
Similar(53)
The company is seeking expanded approval of Targretin to treat non-small-cell lung cancer.
Johnson & Johnson won expanded approval to market Remicade, which it began selling in 1998, for patients who have been newly diagnosed with the crippling joint disorder rheumatoid arthritis.
In the study Allergan submitted to win the expanded approval, patients lost an average of 18 percent of their weight after a year.
He said that even if the F.D.A. expanded approval of the drug only for sleep apnea and shift work, rather than for all sleep disorders, the company would benefit.
Celgene shares rose 2.5% on Friday after the company received expanded approval of cancer treatment Thalomid.
The drug was patented in 1996 and approved for use in erectile dysfunction by the US Food and Drug Administration in 1998 (and expanded approvals were obtained for pulmonary hypertension in 2005).
The F.D.A. deadline of this Friday, the one that has now been extended until Dec. 17, is to decide on Genentech's application to expand the approval of Avastin for breast cancer, not to rescind it.
Trials using clinical outcome endpoints led to approval for 32% (44/137) of supplemental approvals for new indications, 30% (28/93) of modified indication approvals, and 22% (14/65) of expanded population approvals (P=0.29).
Nestlé's sales in China are about to expand significantly, pending approval from the Commerce Ministry to incorporate the Chinese operations of Pfizer, which would increase its market share in infant formula to 12 percent.
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