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
"While we have drafted our responses to questions in the not approvable letter received in September, we feel it is in our best interest to meet with FDA before submission of the official response," said Gene Cartwright, CEO of Guided Therapeutics.
Pfizer submitted a new drug application to the Food and Drug Administration in 2006, and in 2007 got an "approvable letter" that asked for more information.
J&JPRD received an Approvable Letter for the ceftobiprole filing in March 2008, which J&JPRD responded to in August 2008.
But, instead of accelerated approval, the FDA handed back an approvable letter asking for data from the ongoing trial, which was demoted from Phase IV to Phase III.
This filing is in addition to the response that Eurand submitted in August 2008 to the FDA's questions relating to the manufacture of EUR-1008 in its June 2008 approvable letter.
of Brussels, received a not approvable letter from the Food and Drug Administration for this indication in late July, although the agency is still considering the drug's use as an add-on therapy for partial-onset seizures.
SURFAXIN(r), the company's lead product from its KL-4 SRT pipeline, is the subject of an Approvable Letter from the FDA for the prevention of Respiratory Distress Syndrome in premature infants.
The FDA has issued an approvable letter for Wyeth's first-in-class antibiotic TYGACIL (tigecycline) for the treatment of adult patients with community-acquired pneumonia (CAP).
The extended release formulation of guanfacine (Intuniv, manufactured by Shire), can be dosed once a day, and the FDA has issued an approvable letter for this formulation.
DOR BioPharma, Ewing, NJ, announced the company received a not approvable letter from the FDA for its lead product orBec (oral beclomethasone dipropionate, or oral BDP) for the treatment of acute gastrointestinal Graft-Versus-Host-Disease.