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Drugs
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What's New (Drugs)
This page lists recent news items and new and updated pages. Recent New and Generic Drug Approvals appear on a separate page.
Drug Topic Updates:
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November 20, 2009
- Early Communication about an Ongoing Safety Review of Meridia (sibutramine hydrochloride)
- FDA issues letter to Iroko Pharmaceuticals, LLC for the misbranding of Indocin (indomethacin) Oral Suspension (PDF - 41KB)
- Guidance for Industry: Q8(R2) Pharmaceutical Development
- Information for Healthcare Professionals: Peramivir IV Renal Dosing Recommendations
- MedWatch Safety Alert: Vicks Sinex Nasal Spray - Recall
- Opioid Drugs and Risk Evaluation and Mitigation Strategies (REMS) (updated)
November 19, 2009
- FDA Issues the following Warning Letters:
- Chen-Yu Ou
- I-warez
- Dr. Antonio Mendez
- Forrest Media Incorporated
- Orion Star & Associates, Inc.
- Lorna Hillier
- Pro West Marketing Ltd
- BUZZ LLC
- Andrey Petroff
- Sinan Akyuz (for onlinepharmacynorx.info)
- Michael Trinidad - tvforever
- D Hunter
- Sinan Akyuz (for goask.org)
- Chris Walsh c/o Dynadot Privacy
- Xanos Holdings Inc.
- Krest Holdings
- onlinepharmacyy.com
- Med Light LTD
- Ric Deleon
- New Horizons LTD
- William Wynne
- Eugene Lefter
- Drug Safety Oversight Board Meeting, Public Summary, October 15, 2009
November 18, 2009
- Drugs@FDA Download File (updated)
- Medication Guides (updated)
- Paragraph IV Patent Certifications (updated)
November 17, 2009
- FDA issues a Warning Letter for Clinical Investigator Anthony Dallas, M.D.
- Drug Shortages: Current Drug Shortages: Cerezyme (imiglucerase) Injection (updated)
- Drug Shortages: Current Drug Shortages: Fabrazyme (agalsidase beta) (updated)
- Drug Shortages: Current Drug Shortages: Indocin I. V. (indomethacin for injection)
- Drug Shortages: Current Drug Shortages: Methotrexate injection (updated)
- Drug Shortages: Current Drug Shortages: Mitomycin for injection (updated)
- Drug Shortages: Current Drug Shortages: Thiotepa 15mg injection
- Drug Shortages: Current Drug Shortages: Vecuronium Injection
- Information for Healthcare Professionals - Update to the labeling of Clopidogrel Bisulfate (marketed as Plavix) to alert healthcare professionals about a drug interaction with omeprazole (marketed as Prilosec and Prilosec OTC)
- Follow-Up to the January 26, 2009, Early Communication about an Ongoing Safety Review of Clopidogrel Bisulfate (marketed as Plavix) and Omeprazole (marketed as Prilosec and Prilosec OTC)
- Propofol Injection Shortage (updated)
- Public Health Advisory: Updated Safety Information about a drug interaction between Clopidogrel Bisulfate (marketed as Plavix) and Omeprazole (marketed as Prilosec and Prilosec OTC)
November 16, 2009
- Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)
- Drug Master Files
- Pediatric Drug Development: Breakdown of FDAAA Completed Pediatric Studies
November 13, 2009
- FDA issues the following Warning Letters:
- Drug Shortages: Current Drug Shortages: Norpace CR 100 mg and 150 mg capsules
- Information for Healthcare Professionals - Potential Contamination of Products Manufactured by Genzyme Corporation, Marketed as Cerezyme, Fabrayzme, Myozyme, Aldurazyme, and Thyrogen
- Information for Healthcare Professionals - Chondrolysis Reported with Continuously Infused Local Anesthetics (marketed as bupivacaine, chlorprocaine, lidocaine, mepivacaine, procaine and ropivacaine)
- Propofol Injection Shortage (updated)
November 12, 2009
- Drugs@FDA Download File (updated)
November 10, 2009
- IABS/FDA co-sponsored Scientific Conference: Protein Particles and Immunogenicity of Therapeutic Proteins: Filling in the Gaps in Risk Evaluation and Mitigation. November 12-13, 2009, Bethesda, MD. Meeting and Registration Information.
- FDA approves Istodax (romidepsin) for treatment of patients with a rare form of cancer known as Cutaneous T-cell Lymphoma
- MedWatch Alert: Hospira Brand Propofol and Liposyn Products - Recall
November 9, 2009
- Drug Shortages: Current Drug Shortages: Propofol Injection 10mg/ml, 20ml 25s, 50ml 20s, 100ml 10s (updated)
- Guidance for Industry: E7 Studies in Support of Special Populations; Geriatrics; Questions and Answers
November 6, 2009
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BPCA/Pediatric Exclusivity Statistics:
- Pediatric Exclusivity Statistics (updated)
- Written Requests Issued (updated)
- Cancer Drug Development Calculators
- Drug Shortages: Current Drug Shortages: Propofol Injection (updated)
- Emergency Use of Tamiflu in Infants Less than 1 Year of Age (Updated)
- MedWatch Alert: Stiff Nights - product contains undeclared drug ingredient
- MedWatch Alert: Ketorolac Tromethamine Injection, USP 30 mg/mL; 1mL and 2mL Single Dose Vials -- Recall
- MedWatch Alert: Bodybuilding.com Brand Dietary Supplements - Sold on Internet
- Paragraph IV Patent Certifications (updated)
- Rulemaking History for Nonprescription Products: Labeling
November 5, 2009
- Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)
- Public Hearing on Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools. Registration for this Nov. 12-13 meeting is closed. A free webcast will be available, no registration necessary. Webcast information
Meeting information
November 4, 2009
- FDA Unveils Safe Use Initiative that Targets Preventable Harm from Medication Use
- Drug Shortages: Current Drug Shortages: Pentothal (thiopental) Injection
- Drugs@FDA Download File (updated)
- Guidance for Industry: Dosage Delivery Devices for OTC Liquid Drug Products (PDF -93 KB)
November 3, 2009
November 2, 2009
- CDER Manual of Policies and Procedures (MaPP)
- Drug Shortages: Drugs to be Discontinued: Faslodex* (fulvestrant) Injection
- Guidance to Pharmacies on Advance Compounding of Tamiflu Oral Suspension to Provide for Multiple Prescriptions
- Information for Healthcare Professionals: Reports of Altered Kidney Function in patients using Exenatide (Marketed as Byetta)
October 30, 2009
- Guidance for Industry: Individual Product Bioequivalence Recommendations 18 new recommendations added
- FDA issues Procter and Gamble Warning Letter for VICKS DayQuil Plus Vitamin C and VICKS NyQuil Plus Vitamin C
- Approved Risk Evaluation and Mitigation Strategies (REMS) (updated)
- BPCA/Pediatric Exclusivity Statistics: Pediatric Exclusivity Granted (updated)
- Drug Shortages: Current Drug Shortages: Propofol Injection 10mg/ml, 20ml 25s, 50ml 20s, 100ml 10s
- Medication Guides (updated)
- National Drug Code Directory (updated)
- Peramivir IV Questions and Answers for Health Care Providers
- Postmarket Requirements and Commitments (updated)
October 29, 2009
- Drugs@FDA Download File (updated)
- Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)
October 28, 2009
- Drug Shortages: Current Drug Shortages: Azactam 1 gram and 2 gram (aztreonam for injection) (updated)
- Drug Shortages: Current Drug Shortages: Methotrexate injection (updated)
- Drug Shortages: Current Drug Shortages: Mitomycin for injection (updated)
- Drug Shortages: Resolved Drug Shortages: Calcium Disodium Versenate Injection 200 mg/mL 5 mL ampules (NDC 29336-400-10)
October 27, 2009
- Draft Guidance for Industry: SPL Standard for Content of Labeling Technical Qs & As (PDF - 56KB)
- Drug Shortages: Current Drug Shortages: Technetium Tc99m Generators (updated)
- Sanofi-Aventis Warning Letter (Product: Uroxatral) (PDF - 72KB)
October 26, 2009
- 4th Annual FDA/DIA Statistics Forum, April 19-21, 2010, Bethesda, MD. Meeting information and registration.
- DIA/FDA CDER/CBER Computational Science Annual Meeting, March 22-23, 2010, Bethesda, MD. Meeting information and registration.
- Drug Shortages: Resolved Drug Shortages: Dexrazoxane for Injection, Zinecard
- FDA Approves New Treatment for Chronic Lymphocytic Leukemia
- MedWatch Alert on Rituxan (rituximab) and progressive multifocal leukoencephalopathy (PML)
October 23, 2009
- Drug Shortages: Resolved Drug Shortages: Oxycodone Immediate Release Tablets (updated)
- Guidance for Industry: Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects (PDF - 163 KB)
- Information for Healthcare Professionals - Mandatory Adverse Event Reporting for Emergency Use of Peramivir Under EUA
October 22, 2009
- Warning Letters
- Approved Risk Evaluation and Mitigation Strategies (REMS) (updated)
- Drugs@FDA Download File (updated)
October 21, 2009
- Paragraph IV Patent Certifications (updated)
- FDA Approves New Treatment for Advanced Form of Kidney Cancer
- MedWatch Recall Alert for Ketorolac Tromethamine Injection, USP 30 mg/mL; 1mL and 2mL Single Dose Vials
October 20, 2009
October 19, 2009
- Best Pharmaceuticals for Children Act of 2007: List of Determinations Including Written Request (updated)
- Drug Shortages: Current Drug Shortages: Fabrazyme (agalsidase beta) (updated)
- Medication Guides (updated) (new: Darvocet, Darvon, Metozolv, Stelara; updated: Cellcept, Myfortic)
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