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 ?
M2 EQUITYBITES-January 23, 2015-Nevro announces approvable letter from US FDA for Senza Spinal Cord Stimulation System
M2 PHARMA-January 23, 2015-Nevro announces approvable letter from US FDA for Senza Spinal Cord Stimulation System
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.
The company received an approvable letter from the agency for this indication in January.
An approvable letter indicates that the FDA is prepared to approve the application, once conditions specified in the letter are met to the agency's satisfaction.
Shire plc has received an approvable letter from the U.
National Research Center for Women & Families President Diane Zuckerman noted Wood's involvement with Mentor and Inamed's silicone breast implant applications, adding that she had met with Wood to discuss FDA's July approvable letter to Mentor.
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
M2 PHARMA-January 23, 2015-Nevro Receives Approvable Letter from FDA for Senza Spinal Cord Stimulation System