According to the US FDA's approvable
letter, PMA's approval is subject to satisfaction of regulatory inspections and audits of manufacturing facilities, methods and controls for Senza to ensure compliance with the FDA's Quality System Regulation, as well as finalisation of the product's labeling with the FDA.
We are pleased that the FDA, after an intensive review of our submission for Mobi-C, has determined it to be approvable
based on the strength of the data provided in the premarket approval application (PMA).
letter indicates that the FDA has determined that the drug under review has the potential to be approved, but that certain issues need to be addressed or conditions must be met before it is fully approved.
The FDA does not announce or confirm when an approvable
letter has been sent to a company and does not provide information on the conditions outlined in these letters.
letter means that Sanofi-Aventis, the No.
First Ultrasound Device to Receive an Approvable
Letter for Breast Cancer Screening
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.
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.
Tap filed for approval in December 2004, and received the first approvable
letter in October 2005.
23, 2004, letter concluded that Extina was not approvable
because a clinical trial showed that the drug was no better than the placebo foam alone.
BARCELONA, Spain -- SALVAT announced today the submission of the response to the FDA Approvable
Letter for CETRAXAL[R] (Ciprofloxacin 0.
letter was issued the month after publication of data from a phase III clinical trial on tetrabenazine in what the authors said was the first multicenter, prospective, double-bind, placebo-controlled dose-finding study of tetrabenazine for treating chorea in HD.
In October 2004, Advanced Magnetics submitted a complete response to an approvable
letter received from the U.
Announced receipt of an approvable
letter from the FDA for a new formulation of its currently marketed antipsychotic drug FazaClo.
MGI PHARMA received an approvable
letter for Saforis from the U.