FDA's LIST OF DRUGS MARKETED WITHOUT APPROVED NDAs includes one group of 2,400 products dominated by "grandfather" drugs originally marketed before 1938. The largest of three categories making up a list of 5,150 drugs, the "grandfathered" products represent almost half of all drugs marketed without approved NDAs. The grandfather drugs include such items as digitalis, codeine, atropine, thyroid and phenobarbital. FDA prepared the 1,524-page list of unapproved products in response to a request by Rep. Weiss (D-NY) as a follow-up to his May 4 House hearing on E-Ferol, the injectable vitamin E product that was linked to a series of fatalities in premature infants. The second largest category of Rx drugs marketed without an approved NDA are products under DESI review, an estimated 1,800. FDA emphasized "it should be noted that the list of drugs found in this category will be changing rapidly as the future final determinations of efficacy are made . . . and subsequent enforcement class actions are taken." An estimated 950 products don't fall under FDA's DESI review or the grandfather exemption, FDA noted. "Many of these are believed to be products for which no NDA or ANDA is required at all, and therefore, are not subject to the drug listing requirements." For example, FDA said, "more than 400 are Rx biologicals that have been approved under FDA's licensing mechanism rather than the NDA or ANDA mechanisms." Other products in the category "include those which are marketed either as Rx or OTC drugs pending completion of the ongoing review of OTC drugs, certain oral vitamin products for which the food/drug status is still under review, and products which are medical diagnostics." FDA explained that the computer-generated list was compiled from unapproved products contained in the agency's drug listing files as of June 1984. "Because of a time-lag with respect to the reporting of NDA approvals to the system, some recently approved products may be listed as unapproved," the agency said. In addition, "there is often a time-lag between firm's discontinuance of a marketed product and the date that product is delisted from FDA's files." FDA estimated the list is "approximately 95% accurate."
Join thousands of industry professionals who rely on Pink Sheet for daily insights
Already a subscriber?
Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.
We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.
A new pilot aims to take Brazil closer to ‘digital transformation.’
The reductions across medical product programs in the agency’s budget request include hundreds of positions funded by user fees, which may foreshadow its upcoming user fee restructuring strategy.
A new research ethics review system for multi-site clinical trials in Canada is expected to help improve study start-up times, avoid unnecessary duplication and boost the country’s competitiveness on a global stage.
A European Medicines Agency official provided an overview and update of the support the EMA offers developers of innovative products and discussed, among other things, its Innovation Task Force, Quality Innovation Group and a scientific advice pilot for clinical trials.
