CDER New July 25, 2013

What's New on the FDA Drugs Site

July 24, 2013

• Current Drug Shortages Index (updated)
  • Resolved Drugs: Ticlopidine Tablets (updated)
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• Drugs@FDA Data Files (updated)
• FDA Listing of Authorized Generic Drugs (updated)
• Guidance for Industry: 
  • Providing Submissions in Electronic Format – Postmarket Non-Expedited ICSRs Technical Questions and Answers (PDF - 104KB)
  • Pre-Launch Activities Importation Requests (PLAIR) (PDF - KB180)
• National Drug Code Directory 
• Notice to Industry: FDA Issues Draft Guidance for Pre-Launch Importation Requests (PLAIR)

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New and Generic Drug Approvals

July 23, 2013

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Clarinex	desloratadine	Tablet; Oral	Merck Sharp Dohme	Manufacturing Change or Addition
Conray	iothalamate meglumine	Injectable; Injection	Mallinckrodt	Manufacturing Change or Addition
Conray 43	iothalamate meglumine	Injectable; Injection	Mallinckrodt	Manufacturing Change or Addition
Cordran	flurandrenolide	Ointment; Topical	Aqua Pharms	Manufacturing Change or Addition
Cordran Sp	flurandrenolide	Cream; Topical	Aqua Pharms	Manufacturing Change or Addition
Edurant	rilpivirine hydrochloride	Tablet; Oral	Janssen Prods	Manufacturing Change or Addition
Epi E Z Pen Jr	epinephrine	Injectable; Intramuscular	Meridian Medcl Techn	Manufacturing Change or Addition
Epipen	epinephrine	Injectable; Intramuscular	Meridian Medcl Techn	Manufacturing Change or Addition
Epipen E Z Pen	epinephrine	Injectable; Intramuscular	Meridian Medcl Techn	Manufacturing Change or Addition
Epipen Jr.	epinephrine	Injectable; Intramuscular	Meridian Medcl Techn	Manufacturing Change or Addition
Gilotrif	afatinib	Tablet; Oral	Boehringer Ingelheim	Labeling Revision
Hylenex Recombinant	hyaluronidase recombinant human	Injectable; Injection	Halozyme Therap	Manufacturing Change or Addition
Pentasa	mesalamine	Capsule, Extended Release; Oral	Shire	Labeling Revision
Reclast	zoledronic acid	Injectable; Iv (Infusion)	Novartis	Manufacturing Change or Addition
Terazol 3	terconazole	Suppository; Vaginal	Janssen Pharms	Manufacturing Change or Addition
Terazol 3	terconazole	Cream; Vaginal	Janssen Pharms	Manufacturing Change or Addition
Terazol 7	terconazole	Cream; Vaginal	Janssen Pharms	Manufacturing Change or Addition

 

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