CDER New November 18, 2014

What's New on the FDA Drugs Site

November 17, 2014

• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• Drug Safety Communication: FDA reviews long-term antiplatelet therapy as preliminary trial data shows benefits but a higher risk of non-cardiovascular death
• FDA Drug Shortages: New and Updated
  • Ticarcillin disodium and clavulanate potassium (Timentin) Sterile Powder for Injection amp; Sterile Injection (Discontinuation)
• Manual of Policies and Procedures (MAPP) 6030.8 Rev.1 INDs: Exception From Informed Consent Requirements for Emergency Research (PDF - 283KB)
• National Drug Code Directory
• Orange Book (updated)
  • October 2014: Additions and Deletions to the Drug Product List (PDF - 142KB)
  • Orange Book Current Cumulative Supplement (PDF - 1.4MB)
  • Orange Book Data Files (compressed) (ZIP - 592KB)
• Sixth Annual Report on Delays in Approvals of Applications related to Citizen Petitions and Petitions for Stay of Agency Action for Fiscal Year 2013 (PDF - 2MB)

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New and Generic Drug Approvals

November 14, 2014

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Androgel	testosterone	Gel, Metered;Transdermal	Abbvie	Labeling Revision
Androgel	testosterone	Gel;Transdermal	Abbvie	Labeling Revision
Avastin	bevacizumab	Vial; Intravenous	Genentech	Efficacy Supplement with Clinical Data to Support
Campath	alemtuzumab	Vial; Intravenous	Ilex Pharmaceuticals	Labeling Revision
Flovent Hfa	fluticasone propionate	Aerosol, Metered;Inhalation	Glaxo Grp Ltd	Labeling Revision
Fycompa	perampanel	Tablet;Oral	Eisai Inc	Labeling Revision
Obredon	hydrococone bitartrate; guaifenesin	Solution;Oral	Sovereign Pharma Llc	Approval
Omniscan	gadodiamide	Injectable;Injection	Ge Healthcare	Labeling Revision
Precedex	dexmedetomidine hydrochloride	Injectable;Injection	Hospira	Labeling Revision
Precedex	dexmedetomidine hydrochloride	Injectable;Injection	Hospira	Manufacturing Change or Addition
Sovaldi	sofosbuvir	Tablet;Oral	Gilead Sciences Inc	Labeling Revision
Taxotere	docetaxel	Injectable;Injection	Sanofi Aventis Us	Labeling Revision
Tecfidera	dimethyl fumarate	Capsule, Delayed Release;Oral	Biogen Idec Inc	Labeling Revision
Vyvanse	lisdexamfetamine dimesylate	Capsule;Oral	Shire Development	Labeling Revision

 

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— Tuesday, November 18, 2014 — Add Comment