Receives FDA approval for its 4 mg polacrilex nicotine gum (ANDA 74-707) March 19. The Watson Pharmaceutical subsidiary also receives approval for a 2 mg version of the product (ANDA 74-507) March 15. SmithKline Beecham's Nicorette smoking cessation gum, the reference product, lost its Waxman/Hatch exclusivity Feb. 9, but launched a mint-flavored gum in January to stave off the private label competition ("The Tan Sheet" Jan. 18, p. 4). The Circa product is the first private label nicotine gum to be approved by the agency. Novopharm, Gumtech and Perrigo also are expected to market nicotine replacement gum in the future
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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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A new pilot aims to take Brazil closer to ‘digital transformation.’
While the first six months of the year saw eight new drugs targeting a range of diseases enter the European Medicines Agency’s priority medicines scheme, and three PRIME-designated treatments go on to win EU marketing approval, use of the accelerated assessment mechanism appears to be limited.
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The transparency initiative collects CRLs already made public in approval packages on its drugs@fda site to post on the openFDA public portal.
