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.
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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.
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