approvable การใช้

• In May, the FDA issued Roche an approvable letter for the product.
• We think it's approvable,"
• An agency committee found the drug was approvable.
• The drug went on approvable status from 1996.
• On December 2007, the FDA issued a not approvable letter for motexafin gadolinium.
• In the end, we think the product clearly shows a benefit and remains approvable.
• Its MS drug Copaxone won " approvable " status from the FDA this weekend.
• This began a fairly consistent nine-year struggle to develop an approvable plan for construction.
• Knoll has awaited approval since receiving an approvable letter from the agency in November of last year.
• AstraZeneca has said it received an FDA " approvable letter " for Crestor in July.
• In April 2007, the FDA issued Merck a " non-approvable letter " for etoricoxib.
• Currently, the FDA must send a " non-approvable " letter in such cases.
• The company received an initial more limited FDA approvable letter for its GenESA System in mid-May.
• This is a first step towards ultimately developing purified forms of cannabinoids that may be FDA-approvable.
• It received a letter in June from the FDA saying that drug was " approvable ."
• An approvable letter is a conditional approval of a product stipulating conditions that must be met before final marketing clearance.
• The panel will now discuss a series of questions before voting on whether the drug is " approvable ."
• The approvable letter comes just 17 days after an FDA advisory panel said thalidomide can be used safely in certain circumstances.
• The FDA's Internet site, www . fda . gov, has more information on its mifepristone approvable letter.
• An approvable letter usually indicates that the FDA is prepared to approve a drug but only once certain conditions are met.