New and Generic Drug Approvals

New and Generic Drug Approvals

August 6, 2015

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Asmanex Hfa	mometasone furoate	Aerosol, Metered;Inhalation	Merck Sharp Dohme	Manufacturing Change or Addition
Bio-Tropin	somatropin recombinant	Injectable;Injection	Ferring	Manufacturing Change or Addition
Climara	estradiol	Film, Extended Release;Transdermal	Bayer Hlthcare	Manufacturing Change or Addition
Commit	nicotine polacrilex	Troche/Lozenge;Oral	Glaxosmithkline Cons	Labeling Revision
Dulera	formoterol fumarate; mometasone furoate	Aerosol, Metered;Inhalation	Merck Sharp Dohme	Manufacturing Change or Addition
Nicoderm Cq	nicotine	Film, Extended Release;Transdermal	Sanofi Aventis Us	Labeling Revision
Solu-Medrol	methylprednisolone sodium succinate	Injectable;Injection	Pharmacia and Upjohn	Manufacturing Change or Addition
Varithena	polidocanol	Solution;Intravenous	Provensis	Manufacturing Change or Addition
Zomacton	somatropin recombinant	Injectable;Injection	Ferring	Manufacturing Change or Addition

 

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