New and Generic Drug Approvals

By Global Compliance Seminar

December 16, 2014

FDA has announced a list of new and generic drug approvals.  The list is shown below.

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Chg Scrub chlorhexidine gluconate Solution;Topical Ecolab Manufacturing Change or Addition
Cida-Stat chlorhexidine gluconate Solution;Topical Ecolab Manufacturing Change or Addition
Diastat diazepam Gel;Rectal Valeant Pharms North Labeling Revision
Diastat Acudial diazepam Gel;Rectal Valeant Pharms North Labeling Revision
Diclegis doxylamine succinate; pyridoxine hydrochloride Tablet, Delayed Release;Oral Duchesnay Labeling Revision
Primaxin cilastatin sodium; imipenem Powder;Intravenous Merck Labeling Revision
Somatuline Depot lanreotide acetate Injectable;Subcutaneous Ipsen Pharma Supplement
Wellbutrin bupropion hydrochloride Tablet;Oral Glaxosmithkline Labeling Revision
Wellbutrin Sr bupropion hydrochloride Tablet, Extended Release;Oral Glaxosmithkline Labeling Revision

2014 December FDA New and Generic Drug Approvals
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