approvable letter

approvable letter

An official communication from the Food & Drug Administration to a New Drug Application (NDA) sponsor which indicates the product can be approved after minor issues are resolved.
References in periodicals archive ?
to the FDA approvable letter for Once-A-Day LUVOX(R) CR (fluvoxamine maleate) Extended-Release Capsules.
An approvable letter indicates that the FDA has determined that the drug under review can be approved, but that certain issues need to be addressed or conditions must be met before it is fully approved.
In the July approvable letter, the FDA stated that the drug's manufacturer, Wyeth Pharmaceuticals, would have to provide more data about the potential for serious adverse cardiovascular and hepatic effects associated with the use of the desvenlafaxine for this indication, according to the company.
TSX: DDS, NASDAQ: DDSS) today announced that it has received a second approvable letter from the U.
Shire plc has received an approvable letter from the U.
This decision follows a number of meetings with the FDA since October 2004, when the Company received an Approvable Letter from the FDA for Riquent.
Vancouver, British Columbia, announced that its licensee Shire Pharmaceuticals Group plc, Basingstoke, UK, has received an approvable letter from the FDA for Fosrenol as a treatment for high phosphate levels in the blood, which occur in patients undergoing dialysis as a result of chronic kidney failure.
First Ultrasound Device to Receive an Approvable Letter for Breast Cancer Screening
Food and Drug Administration (FDA) has issued an approvable letter for Once-A-Day LUVOX(R) CR (fluvoxamine maleate) Extended-Release Capsules, for which Jazz Pharmaceuticals and Solvay Pharmaceuticals, Inc.
An approvable letter for a drug indicates that the FDA has determined that the drug should be approved, but that certain issues need to be addressed or conditions (such as an agreement to conduct postmarketing studies) must be met.
BARCELONA, Spain -- SALVAT announced today the submission of the response to the FDA Approvable Letter for CETRAXAL[R] (Ciprofloxacin 0.
The 2006 Approvable Letter requested that the company reanalyze data from certain preclinical and clinical studies to support approval of indiplon 5 mg and 10 mg capsules for sleep initiation and middle of the night dosing.