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CDER New July 16, 2015

FDA (U.S. Food and Drug Administration)

What's New on the FDA Drugs Site

July 15, 2015

New and Generic Drug Approvals

July 14, 2015

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Agrylin anagrelide hydrochloride Capsule;Oral Shire Llc Labeling Revision
Auryxia ferric citrate Tablet;Oral Keryx Biopharms Manufacturing Change or Addition
Bivalirudin bivalirudin Injectable; Injection Hospira Inc Approval
Levetiracetam In Sodium Chloride levetiracetam Injectable;Iv (Infusion) Hq Speciality Pharma Manufacturing Change or Addition
Lotensin benazepril hydrochloride Tablet;Oral Us Pharms Holdings I Manufacturing Change or Addition
Magnesium Sulfate In Dextrose 5% In Plastic Container magnesium sulfate Injectable;Injection Hospira Manufacturing Change or Addition
Miralax polyethylene glycol 3350 For Solution;Oral Bayer Healthcare Llc Manufacturing Change or Addition
Olopatadine Hydrochloride olopatadine hydrochloride Solution; Ophthalmic Barr Approval
Orbactiv oritavancin diphosphate Powder;Iv (Infusion) The Medicines Co Manufacturing Change or Addition
Pepcid Complete calcium carbonate; famotidine; magnesium hydroxide Tablet, Chewable;Oral Mcneil Cons Manufacturing Change or Addition
Potassium Chloride potassium chloride Solution;Oral Pharma-Med Inc Manufacturing Change or Addition
Tecfidera dimethyl fumarate Capsule, Delayed Release;Oral Biogen Idec Inc Manufacturing Change or Addition
Valcyte valganciclovir hydrochloride For Solution;Oral Hoffmann La Roche Manufacturing Change or Addition
Zerit stavudine Capsule;Oral Bristol Myers Squibb Manufacturing Change or Addition
Zontivity vorapaxar sulfate Tablet;Oral Merck Sharp Dohme Manufacturing Change or Addition


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