SCHERING-PLOUGH NITRO-DUR NITRO PATCH SUPPLEMENTAL NDAs APPROVED by FDA on April 4, making the nitroglycerin transdermal infusion system the first pre-1962 nitroglycerin product in a patch form to have fully approved NDAs. FDA asked manufacturers of nitro patches to submit NDAs for the DESI drugs in a Federal Register notice of July 15, 1993 ("The Pink Sheet" July 19, 1993, T&G-2). Nitro-Dur and Ciba/Summit's Transderm-Nitro were then deemed the "reference drugs."
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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.’
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