New and Generic Drug Approvals

December 4, 2014

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Acuvail	ketorolac tromethamine	Solution/Drops;Ophthalmic	Allergan	Labeling Revision
Idamycin	idarubicin hydrochloride	Injectable;Injection	Pharmacia and Upjohn	Labeling Revision
Idamycin Pfs	idarubicin hydrochloride	Injectable;Injection	Pharmacia and Upjohn	Labeling Revision
Jakafi	ruxolitinib phosphate	Tablet;Oral	Incyte Corp	Efficacy Supplement with Clinical Data to Support
Lastacaft	alcaftadine	Solution/Drops;Ophthalmic	Allergan	Labeling Revision
Mozobil	plerixafor	Solution;Subcutaneous	Genzyme	Labeling Revision
Pamidronate Disodium	pamidronate disodium	Injectable;Injection	Eurohlth Intl	Labeling Revision
Vizamyl	flutemetamol f-18	Injectable;Intravenous	Ge Healthcare	Labeling Revision

 

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