CDER New August 6, 2015

What's New on the FDA Drugs Site

August 5, 2015

• Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Prescription Drugs Guidance for Industry (PDF - 304KB)
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• Drug Trials Snapshots:
  • REXULTI: For the treatment of major depressive disorder 
  • REXULTI: For the treatment of schizophrenia
• Drugs@FDA Data Files (updated)
• National Drug Code Directory
• Paragraph IV Patent Certifications (updated)

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New and Generic Drug Approvals

August 4, 2015

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Auryxia	ferric citrate	Tablet;Oral	Keryx Biopharms	Manufacturing Change or Addition
Depocyt	cytarabine	Injectable, Liposomal;Injection	Pacira Pharms Inc	Manufacturing Change or Addition
Gelnique	oxybutynin chloride	Gel;Transdermal	Actavis Labs Ut Inc	Manufacturing Change or Addition
Gilenya	fingolimod	Capsule;Oral	Novartis	Labeling Revision
Mozobil	plerixafor	Solution;Subcutaneous	Genzyme	Labeling Revision
Phenergan	promethazine hydrochloride	Suppository;Rectal	Delcor Asset Corp	Manufacturing Change or Addition
Phenergan	promethazine hydrochloride	Suppository;Rectal	Delcor Asset Corp	Manufacturing Change or Addition
Prozac Weekly	fluoxetine hydrochloride	Capsule, Delayed Rel Pellets;Oral	Lilly	Labeling Revision
Vascepa	icosapent ethyl	Capsule;Oral	Amarin Pharms	Manufacturing Change or Addition

 

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— Thursday, August 6, 2015 — Add Comment