What's New at CDER http://www.fda.gov/cder/whatsnew.htm en-us Tue, 26 May 2009 10:55 EDT cderwebmaster@fda.hhs.gov (CDER Webmaster) Current Drug Shortages: Technetium Tc99m Generators, See letter in Related Information Section Tue, 26 May 2009 10:55 EST http://www.fda.gov/cder/drug/shortages/default.htm#technetium Guidance for Industry: Presenting Risk Information in Prescription Drug and Medical Device Promotion Tue, 26 May 2009 07:45 EDT http://www.fda.gov/cder/guidance/7427dft.pdf Agenda for the May 27 - 28, 2009 Opioid REMS Public Meeting Fri, 22 May 2009 12:35 EDT http://www.fda.gov/cder/meeting/opioid/OpioidREMSPublicMeetingFinalAgenda.pdf Current Drug Shortages: Technetium Tc99m Generators, Reduced supply due to material sourcing issues, Covidien: 1-888-744-1414 (Ultra-Technekow DTE, NDA 17-243) and Lantheus: 1-800-299-3431 (Technelite, NDA 17-771) Thu, 21 May 2009 13:35 EST http://www.fda.gov/cder/drug/shortages/default.htm#technetium Drugs@FDA Downloadable Data Files Wed, 20 May 2009 15:15 EDT http://www.fda.gov/cder/drugsatfda/datafiles/default.htm Current Drug Shortages: Morphine Sulfate Oral Solution, See updated Dear Healthcare Provider Letter in the Related Information section Wed, 20 May 2009 10:00 EDT http://www.fda.gov/cder/drug/shortages/default.htm#Morphine Office of Generic Drugs: Paragraph IV Patent Certifications (updated) Tue, 19 May 2009 15:05 EDT http://www.fda.gov/cder/ogd/ppiv.htm Current Drug Shortages: Isoniazid Injection (NDC 00781-3056-70), Product continues to be available with short expiration dating, Sandoz has continued to make isoniazid injection available and the product may be ordered through wholesalers, Sandoz (customer service number) 1-800-525-8747 Tue, 19 May 2009 13:50 EDT http://www.fda.gov/cder/drug/shortages/default.htm#Isoniazid Resolved Drug Shortages: Enlon (edrophonium chloride) injection and Enlon Plus (edrophonium chloride and atropine sulfate) injection, See Company Information for updated contact information Tue, 19 May 2009 13:40 EDT http://www.fda.gov/cder/drug/shortages/default.htm#Enlon Review and Conduct of Human Subject Research Tue, 19 May 2009 10:55 EDT http://www.fda.gov/cder/mapp/7700.2.pdf Formal Meetings Between the FDA and Sponsors or Applicants Tue, 19 May 2009 10:43 EDT http://www.fda.gov/cder/guidance/7476fnl.pdf Adverse Event Reporting System (AERS) Statistics (updated) Mon, 18 May 2009 18:10 EDT http://www.fda.gov/cder/aers/statistics/default.htm Current Drug Shortages: Methotrexate injection, Ebewe Parenta Pharmaceuticals, Inc. (1-800-898-9948) is now accepting orders for preservative-free methotrexate injection and shipment is planned for the first week of June. Mon, 18 May 2009 11:30 EDT http://www.fda.gov/cder/drug/shortages/default.htm#Methotrexate Resolved Drug Shortages: Enlon (edrophonium chloride) injection and Enlon Plus (edrophonium chloride and atropine sulfate) injection, Bioniche Pharma has available the Enlon Plus 5 mL ampule (NDC 67457-0192-05) and the Enlon (NDC 67457-0190-15). The Enlon Plus multi- dose vials (NDC 67457-0191-15) are anticipated to be available soon. Mon, 18 May 2009 11:30 EDT http://www.fda.gov/cder/drug/shortages/default.htm#Enlon Current Drug Shortages: Dexrazoxane for Injection, Zinecard, Manufacturing delays, Totect remains in limited availability, labeled for use in treatment of extravasation resulting from IV anthracycline chemotherapy. TopoTarget inquiries: 1-866-470-8247 Fri, 15 May 2009 07:10 EDT http://www.fda.gov/cder/drug/shortages/default.htm#Dexrazoxane Current Drug Shortages: Oxycodone Immediate Release Tablets (5mg, 15mg and 30mg), See website for updated information Thu, 14 May 2009 12:00 EDT http://www.fda.gov/cder/drug/shortages/default.htm#Oxycodone Drug Safety Oversight Board Meetings: Public Summaries, April 16, 2009 Wed, 13 May 2009 10:45 EDT http://www.fda.gov/cder/drug/DrugSafety/DSOBmeetings/DSOB20090416.htm Resolved Drug Shortages: Fentanyl transdermal patch, See update in Company name for Teva, in the Related Information section Wed, 13 May 2009 09:55 EDT http://www.fda.gov/cder/drug/shortages/default.htm#Fentanyl Best Pharmaceuticals for Children Act of 2007: List of Determinations Including Written Request (updated) Wed, 13 May 2009 06:50 EDT http://www.fda.gov/cder/pediatric/bpca_determination.htm Office of Generic Drugs: April First-Time Generic Drug Approvals Wed, 13 May 2009 06:50 EDT http://www.fda.gov/cder/ogd/approvals/default.htm Labeling OTC Human Drug Products; Small Entity Compliance Guide Tue, 12 May 2009 11:35 EDT http://www.fda.gov/cder/guidance/6920fnl.pdf Current Drug Shortages: Oxycodone Immediate Release Tablets (5mg, 15mg and 30mg), See updated Company Information section on Xanodyne Pharmaceuticals, Inc Mon, 11 May 2009 11:20 EDT http://www.fda.gov/cder/drug/shortages/default.htm#Oxycodone Current Drug Shortages: Cisplatin Injection 1mg/ml : See updated Related Information Section for Teva Mon, 11 May 2009 10:40 EDT http://www.fda.gov/cder/drug/shortages/default.htm#Cisplatin Best Pharmaceuticals for Children Act of 2007: List of Determinations Including Written Request (updated) Mon, 11 May 2009 09:50 EDT http://www.fda.gov/cder/pediatric/bpca_determination.htm BPCA/Pediatric Exclusivity Statistics (updated) Mon, 11 May 2009 09:50 EDT http://www.fda.gov/cder/pediatric/index.htm Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505A and 505B of the FDA (the Act), as amended by the FDA Amendments Act of 2007 (FDAAA) Mon, 11 May 2009 09:50 EDT http://www.fda.gov/cder/pediatric/BpcaPrea_full_review.htm CDER Organization Charts (updated) Fri, 08 May 2009 15:50 EDT http://www.fda.gov/cder/cderorg.htm The Dear Colleague Letter, in anticipation of FY 2010 Invoices, was mailed Tuesday, May 5, 2009 Fri, 08 May 2009 09:40 EDT http://www.fda.gov/cder/pdufa/letters.htm Current Drug Shortages: Mitomycin for injection: See updated Related Information Section Fri, 08 May 2009 09:40 EDT http://www.fda.gov/cder/drug/shortages/default.htm#Mitomycin Testosterone Gel Safety Concerns Prompt FDA to Require Label Changes, Medication Guide Fri, 08 May 2009 08:50 EDT http://www.fda.gov/cder/drug/infopage/testosterone_gel/default.htm Comprehensive List of Guidance Documents Thu, 07 May 2009 12:40 EDT http://www.fda.gov/cder/guidance/CompList200904.pdf New Revised/Withdrawn List for 2009 Thu, 07 May 2009 12:40 EDT http://www.fda.gov/cder/guidance/newrevwd200904.pdf Current Drug Shortages: Metoprolol succinate extended release tablets: See updated letter in Related Information Section Thu, 07 May 2009 10:40 EDT http://www.fda.gov/cder/drug/shortages/default.htm#metoprolol Current Drug Shortages: Mitomycin for injection: Ben Venue is shipping product, with allocation in effect, customer service: 1-800-562-4797 Thu, 07 May 2009 10:40 EDT http://www.fda.gov/cder/drug/shortages/default.htm#Mitomycin BRisk Evaluation and Mitigation Strategy (REMS) Under Review for CellCept and Myfortic Wed, 06 May 2009 15:10 EDT http://www.fda.gov/cder/drug/infopage/mycophenolate/REMS.htm BPCA/Pediatric Exclusivity Statistics: Pediatric Exclusivity Granted (updated) Wed, 06 May 2009 08:00 EDT http://www.fda.gov/cder/pediatric/exgrant.htm Office of Generic Drugs: Paragraph IV Patent Certifications (updated) Mon, 04 May 2009 14:45 EDT http://www.fda.gov/cder/ogd/ppiv.htm Division of Drug Marketing, Advertising, and Communications: Presentations (updated) Mon, 04 May 2009 13:20 EDT http://www.fda.gov/cder/ddmac/presentations.htm Drugs@FDA Downloadable Data Files (updated) Fri, 01 May 2009 14:15 EDT http://www.fda.gov/cder/drugsatfda/datafiles/default.htm FDA has approved pancrelipase (Creon Delayed-Release Capsules) for adult and pediatric patients with exocrine pancreatic insufficiency Fri, 01 May 2009 14:00 EDT http://www.fda.gov/cder/drug/infopage/pancrelipase/default.htm Office of Nonprescription Products: Rulemaking History for Nonprescription Products (updated) Fri, 01 May 2009 09:20 EDT http://www.fda.gov/cder/otcmonographs/rulemaking_index.htm Current Drug Shortages: Methotrexate injection: Bedford Laboratories- manufacturing delays, Hospira- unable to meet demand, GeneraMedix- increase in demand and APP has product available. See Related Information section for more information Thu, 30 Apr 2009 14:20 EDT http://www.fda.gov/cder/drug/shortages/default.htm#Methotrexate FDA updates the Early Communication about an Ongoing Safety Review of Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B) Thu, 30 Apr 2009 13:50 EDT http://www.fda.gov/cder/drug/early_comm/botulinium_toxins200904.htm Label Comprehension Studies for Nonprescription Drug Products Thu, 30 Apr 2009 08:00 EDT http://www.fda.gov/cder/guidance/2925dft.pdf Individual Product Bioequivalence Recommendations Wed, 29 Apr 2009 16:18 EDT http://www.fda.gov/cder/guidance/bioequivalence/default.htm Scientific Interest Groups: Criteria and Policies Tue, 28 Apr 2009 16:10 EDT http://www.fda.gov/cder/mapp/5100.4.pdf Current Drug Shortages: Morphine Sulfate Oral Solution, Roxane- has product available. See information in Related Information section, Mallinckrodt- Increased demand due to another manufacturer leaving the market, Lannett-Increased demand due to another manufacturer leaving the market, and Glenmark- Increased demand due to another manufacturer leaving the market Tue, 28 Apr 2009 16:00 EDT http://www.fda.gov/cder/drug/shortages/default.htm#Morphine Resolved Drug Shortages: Levoleucovorin (Fusilev) 50 mg single use vials, see Related Information Section Mon, 27 Apr 2009 11:35 EDT http://www.fda.gov/cder/drug/shortages/default.htm#Levoleucovorin Resolved Drug Shortages: Leucovorin Calcium Solution for Injection, see Related Information Section Mon, 27 Apr 2009 11:35 EDT http://www.fda.gov/cder/drug/shortages/default.htm#Leucovorin Drugs@FDA Downloadable Data Files (updated) Thu, 23 Apr 2009 16:00 EDT http://www.fda.gov/cder/drugsatfda/datafiles/default.htm Approved Drug Products with Therapeutic Equivalence Evaluations Orange Book Thu, 23 Apr 2009 14:55 EDT http://www.fda.gov/cder/orange/default.htm FDA updates action on Plan B (levonorgestrel) tablets Thu, 23 Apr 2009 14:55 EDT http://www.fda.gov/bbs/topics/NEWS/2009/NEW01999.html Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conductedf under Section 505A and 505B of the FDA (the Act), as amended by the FDA Amendments Act of 2007 (FDAAA) Thu, 23 Apr 2009 14:55 EDT http://www.fda.gov/cder/pediatric/BpcaPrea_full_review.htm Current Drug Shortages: Metoprolol succinate extended release tablets, see updated letter in Related Information Section Mon, 20 Apr 2009 15:55 EDT http://www.fda.gov/cder/drug/shortages/default.htm#metoprolol Resolved Drug Shortages: Acyclovir Injection, APP currently has all presentations available and Bedford currently reports available product for drop shipment Mon, 20 Apr 2009 15:55 EDT http://www.fda.gov/cder/drug/shortages/default.htm#Acyclovir Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505A and 505B of the FDA (the Act), as amended by the FDA Amendments Act of 2007 (FDAAA) Mon, 20 Apr 2009 15:00 EDT http://www.fda.gov/cder/pediatric/BpcaPrea_full_review.htm Integrated Summaries of Effectiveness and Safety: Location Within the Common Technical Document Mon, 20 Apr 2009 12:45 EDT http://www.fda.gov/cder/guidance/8524fnl.pdf Office of Generic Drugs: Paragraph IV Patent Certifications (updated) Mon, 20 Apr 2009 12:35 EDT http://www.fda.gov/cder/ogd/ppiv.htm