January 31, 2009Tainted Weight Loss Pills Flagged as Health Risks Tainted Weight Loss Pills Flagged as Health Risks
FDA has alerted consumers not to buy or use more than 25 weight-loss products. Guidance for Industry Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions Annex 2 Test for Extractable Volume of Parenteral Preparations General Chapter Drug Shortages: Current Drug Shortages; Alprostadil 0.5 mg/mL injection Alprostadil 0.5 mg/mL injection: Teva Pharmaceuticals: Manufacturing delays; Bedford: Manufacturing delays; Pfizer, Inc.- Prostin VR pediatric Injection available from Pfizer January 30, 2009Mexican Vanilla With Coumarin: No Bargain Mexican Vanilla With Coumarin: No Bargain
Beware of Mexican vanilla that contains coumarin, a toxic substance banned in the United States. November 2008 Safety Related Labeling Changes Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of drug Prescribing Information, plus Patient Package Inserts and Medication Guides. January 29, 2009Avoiding Drug Interactions Avoiding Drug Interactions
Be careful about the three main types of interactions: drugs with food and beverages, drugs with dietary supplements, and drugs with other drugs. Drugs@FDA Downloadable Data Files (updated) Drugs@FDA Downloadable Data Files (updated) Drug Shortages: Resolved Drug Shortages; Vinblastine Sulfate Injection See Related information section Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies 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) Use Caution With Ayurvedic Products The presence of heavy metals in some Ayurvedic products makes them potentially harmful. Recalls and Melamine Contamination FDA has increased inspections and product testing in response to the melamine contamination problem that originated in Chinese dairy products. Beware of Extortion Scam by FDA Impersonators As part of a fraudulent scheme to extort money, callers have falsely identified themselves as "FDA special agents" or other FDA officials. Safety Concerns and Labeling Changes for Psoriasis Drug Raptiva FDA has received reports of serious infections leading to hospitalizations and deaths in people who use Raptiva. Rulemaking History for Nonprescription Products Office of Nonprescription Products: Rulemaking History for Nonprescription Products (updated) Orange Book Approved Drug Products with Therapeutic Equivalence Evaluations Orange Book (updated) Paragraph IV Patent Certifications Paragraph IV Patent Certifications
Office of Generic Drugs: Paragraph IV Patent Certifications (updated) Drug Shortages: Current Drug Shortages; Leucovorin Please call 1-888-TevaUSA for additional information. Teva is manufacturing at full capacity. Bedford Customer Service 1-440-232-3320 Food Safety Tips for Healthy Holidays FDA gives consumers practical food safety tips to help prevent foodborne illness. January 28, 2009Drug Firm Annual Registration Status Drug Firm Annual Registration Status
Drug Firm Annual Registration Status updated. The status report now includes Data Universal Numbering System Number. Guidance for Industry Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions Annex 2 Test for Extractable Volume of Parenteral Preparations General Chapter Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies 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) Drug Shortages: Resolved Drug Shortages; MVI Adult Injectable No further supply issues are anticipated Recalls and Safety Alerts: Serious Infections and Neurological Events with Raptiva FDA is highlighting the risk of life-threatening infections in patients treated with Raptiva (efalizumab). Raptiva is an immunosuppressant approved as a once a week injection to treat certain adult patients with moderate to severe plaque psoriasis. ... Prescription Drug Leaflets Need Improvement Prescription Drug Leaflets Need Improvement
Improvement is needed for the printed consumer medication information (CMI) that accompanies new prescriptions. Venom HYPERDRIVE 3.0 Product marketed as dietary supplement contains undeclared sibutramine, a controlled substance with risks for abuse or addiction, and can substantially increase blood pressure and heart rate. Stryker Custom Cranial Implant Kits Class 1 recall because sterility cannot be assured. Innohep (tinzaparin sodium injection) [UPDATE] Dear Healthcare Professional letter issued re: increased risk of death in elderly patients with renal insufficiency FDA Prevents Two Dairies from Adulterating Animal Drugs and Food The U.S. Food and Drug Administration announced today that the District Court for the District of New Mexico has enjoined Do-Rene and Clover Knolls Dairies and their owners, Douglas B. Handley and Irene Handley, from adulterating new animal drugs and introducing adulterated food into commerce. Both companies are based in Clovis, N.M. FDA Warns Consumers Against Dietary Supplement Containing Undeclared Drug FDA Warns Consumers Against Dietary Supplement Containing Undeclared Drug
he U.S. Food and Drug Administration is warning consumers not to take Venom HYPERDRIVE 3.0, a product sold as a dietary supplement and containing sibutramine. Sibutramine, a controlled substance with risks for abuse or addiction, is a potent drug that poses potential safety risks. FDA Approves RiaSTAP for Treatment of Bleeding in Patients with Rare Genetic Defect The U.S. Food and Drug Administration today licensed RiaSTAP, an orphan drug for the treatment of bleeding in patients with a rare genetic defect known as congenital fibrinogen deficiency. Without treatment, these patients are at risk of potentially life-threatening bleeding. Guidance for Industry Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions Annex 2 Test for Extractable Volume of Parenteral Preparations General Chapter Stryker Custom Cranial Implant Kits Class 1 recall because sterility cannot be assured. Guidance for Industry Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices U.S. BPCA/Pediatric Exclusivity Statistics BPCA/Pediatric Exclusivity Statistics (updated) January 27, 2009Ezetimibe/Simvastatin (marketed as Vytorin), Ezetimibe (marketed as Zetia), and Simvastatin (marketed as Zocor): Update of Safety Review Ezetimibe/Simvastatin (marketed as Vytorin), Ezetimibe (marketed as Zetia), and Simvastatin (marketed as Zocor): Update of Safety Review
The FDA has completed its review of the final clinical study report of ENHANCE and issued an update. Stryker Custom Cranial Implant Kits Class 1 recall because sterility cannot be assured. Drug Shortages: Resolved Drug Shortages; Zanosar (Streptozocin) 1gm/vial Injection See Web site for additional information Hydromorphone HCl 2 mg Tablets Nationwide recall of a single lot due to potential for oversized tablets. Drug Shortages: Current Drug Shortages; Levoleucovorin (Fusilev) 50 mg single use vials See Web site for additional information Recalls and Safety Alerts: Serious Complications with Surgical Mesh for Gynecologic Surgery The FDA is alerting healthcare professionals about rare but serious complications associated with the surgical mesh used to treat pelvic organ prolapse and stress urinary incontinence. The mesh is usually placed transvaginally using minimally invasi... Drug Shortages: Current Drug Shortages; Ultra-TechneKow DTE (Technetium Tc 99m Generator) NDA 17-243 See Web site for additional information on this current drug shortage Guidance for Industry Guidance for Industry
Animal Models — Essential Elements to Address Efficacy Under the Animal Rule Source: www.fda.gov |
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