Date: January 3 - January 6, 2005 January 6, 2006 Upcoming Workshops: Webinar:  CDER Town Meeting: Current Hot Topics Regarding eSubmissions.  January 18, 2006.  Program and Registration [external site] Webinar:  The Current Implementation Status of Electronic Case Reporting.  January 19, 2006.  Program and Registration [external site] Paragraph IV Patent Certifications (updated) January 5, 2006 New and Generic Drug Approvals Apidra (insulin glulisine [rDNA origin]) injection, Aventis Pharma, Labeling Revision & Package Change Baclofen Tablets, Lannett Holdings, Approval Children's Motrin Cold Suspension, McNeil Consumer, Labeling Revision Citalopram Hydrobromide ODT, Biovail, Approval 021763 Gonal-f RFF (follitropin alfa for injection), Serono, Control Supplement Ibuprofen Capsules, Banner Pharmacaps, Labeling Revision Metformin Hydrochloride Extended-Release Tablets, Mutual Pharma, Approval Nexavar (Sorafenib) Tablets, Bayer Pharma, Approval Spectracef (cefditoren pivoxil) tablets, Purdue Pharma, Labeling Revision Public Service Announcement added to Consumer Education web page:  "WARNING: Antibiotics don't work for viruses like colds and the flu. Using them for viruses will not make you feel better or get back to work faster." January 4, 2006 Bioresearch Monitoring Information System File (updated) Drugs@FDA Downloadable Data Files (updated) Investigational Human Drugs: Clinical Investigator Inspection List (CLIIL) (updated) On December 28, FDA approved Femara (letrozole tablets) for the adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer. On December 29, 2005, FDA approved first-time generic Cabergoline tablets for treatment of hyperprolactinemic disorders, either idiopathic or due to pituitary adenomas. The reference listed drug is Dostinex. On December 29, FDA tentatively approved Nevirapine Oral Suspension, 50mg/mL. This product was reviewed under the President's Emergency Plan for AIDS Relief (PEPFAR). The reference listed drug is Viramune Oral Suspension. FDA has approved ten applications for generic Zonisamide capsules for adjunctive therapy in the treatment of partial seizures in adults with epilepsy. The reference listed drug is Zonegran. On December 23, FDA approved Orencia (abatacept) for reducing signs and symptoms, inducing major clinical response, slowing the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more DMARDs, such as MTX or a TNS antagonist. New and Generic Drug Approvals Advil PM Liqui-Gels, Wyeth Consumer, Approval Advil PM Caplets, Wyeth Consumer, Approval Cefprozil Oral Suspension, Par Pharma, Approval Finasteride Tablets, Watson Labs, Tentative Approval Flovent HFA (fluticasone propionate Inhalation Aerosol, GlaxoSmithKline, Labeling Revision Fosamax (alendronate sodium) Tablets, Merck & Co., New or Modified Indication Fosamax (alendronate sodium) Oral Solution, Merck & Co., Labeling Revision Oxycodone and Acetaminophen Tablets, Mikart, Approval Rivastigmine Tartrate Oral Solution, Ranbaxy Labs, Tentative Approval ROWASA (mesalamine) Rectal Suspension Enema, Solvay Pharma, Labeling Revision Sertraline Hydrochloride Tablets, Pliva, Tentative Approval Simvastatin Tablets, Teva Pharma, Tentative Approval Tamiflu (oseltamivir phosphate) Oral Suspension, Hoffman-La Roche, Patient Population Altered Tamiflu (oseltamivir phosphate) Capsules, Hoffman-La Roche, Patient Population Altered January 3, 2006 Guidance for Industry:  Recommended Approaches to Integration of Genetic Toxicology Study Results [HTML] or [Word] or [PDF] Comprehensive List of Guidance Documents (updated 1/3/2006) New and Generic Drug Approvals Cabergoline Tablets, Par Pharma, Approval Climara Pro (estradiol/levonorgestrel) Transdermal System, Berlex Labs, Approval Doxycycline Hyclate Delayed Release Capsules, Sandoz Inc., Approval Femara (Letrozole) Tablets, Novartis Pharma, New or Modified Indication Menostar (estradiol transdermal system), Berlex Labs, Labeling Revision New/Revised/Withdrawn List for 2005 (updated 1/3/2006) We welcome any feedback or suggestions. webmaster@cder.fda.gov. If you prefer to subscribe to the previous text-only version, please send us a message.   ---------------------------------------------To subscribe or to unsubscribe from CDERWEEKwww.fda.gov/cder/cdernew/listserv.html --------------------------------------------- CDER Home PageContact CDER | FDA Home Page | HHS Home Page U.S. Food and Drug Administration Center for Drug Evaluation and Research 1-888-INFO-FDA (1-888-463-6332)

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