UNIMED's MARINOL NDA WILL BE RESUBMITTED after the company meets with FDA to discuss the agency's withdrawal of an "approvable letter" for the drug, the company announced in a Nov. 7 press release. Unimed President and CEO Paul Bollenbacher said that the company plans "to move quickly to resubmit the application and satisfy all of their [FDA's] requirements." The company said FDA withdrew the July 31 "approvable letter" for Marinol (dronabinol-THC) because "of certain deficiencies related to two clinical tests which were viewed as pivotol to the agency's ability to judge Marinol as safe and effective." Bollenbacher commented that he was "absolutely dumbfounded by the FDA's decision, since the company has submitted additional data, including labeling information, to the FDA in August." Unimed filed an NDA for Marinol in June 1981. The drug, used to control vomiting and nausea associated with chemotherapy, has been distributed by the Natl. Cancer Institute (NCI) for the last four years. Approximately 800 hospitals, 2,600 doctors, and 25,000 cancer patients have participated in NCI's free THC distribution program, Unimed stated. Unimed has at least two other drugs in clinicals, an anticancer agent Spiro-32 spiro-germanium), and Serc (betahistamine HCI) for the treatment of cerebrovascular disease. The company said it has not been pursuing studies of its L-alpha-acetyl-methadol, a long-acting drug for use in controlled withdrawal from morphine-type addiction, "because of some problems with safety raised by FDA."
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.’
England’s Court of Appeal has upheld a Competition Appeal Tribunal’s 2023 finding that Advanz and its former owner Cinven abused their dominant position in the UK market for liothyronine tablets by charging prices that were many orders of magnitude higher than the benchmark for fair pricing.
Linerixibat, GSK's treatment for cholestatic pruritus in patients with primary biliary cholangitis, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
US FDA critics have long decried the practice of using informal communications to convey regulatory expectations as podium policy. In the Makary era, the phrase may need to be updated because the agency now seems to be specializing in policy by podcast.
