DANBURY's MINOXIDIL ANDA APPROVAL IS FIRST GENERIC version of Upjohn's antihypertensive agent Loniten. The patent for Loniten expired in July 1985. FDA approved the generic oral minoxidil in 2.5 mg and 10 mg tablets on March 3 and the company began shipping the product March 6. Introduced in 1979, Loniten sales increased dramatically in 1983 and 1984 due to recompounding of the drug for use as an antibaldness treatment. Analysts' estimates of Loniten annual sales are in the $30 mil. range with well over half coming from the unapproved baldness use. Upjohn's NDA for the topical antibaldness drug Rogaine is to be reviewed by FDA's Dermatologic Drugs Advisory Committee March 16. Last April FDA directed its regional compliance offices to issue regulatory letters to approximately 50 firms, primarily hair and scalp treatment centers, that were understood to be promoting reformulated minoxidil for hair growth. In August 1985 the agency requested Upjohn to change minoxidil labeling to specifically caution against recompounding for hair regeneration.
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.
