CIBA-GEIGY's ESTRADERM (ESTRODIAL) TRANSDERMAL PATCH for treatment of menopausal symptoms was approved by FDA Sept. 10. The product is available in dosages of 0.05 mg and 0.1 mg to be applied twice weekly. Estraderm is Ciba-Geigy's third transdermal patch product utilizing Alza's delivery system. Ciba's Transderm Scop (scopolamine) was the first transdermal product on the market, followed by three nitroglycerin patches, of which Transderm-Nitro is the market leader. Estraderm is the third drug class to be made available in a transdermal delivery system. Boehringer Ingelheim's antihypertensive Catapres (clonidine) is the only other product line besides nitroglycerin. Ciba-Geigy obtained approval for Estraderm two years after an NDA submission in August 1984. FDA's Fertility and Maternal Health Drugs Advisory Cmte. recommended it for approval last December. The transdermal estrogen product is currently in clinicals for osteoporosis.
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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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