February 28, 2009Drug Shortages: Drugs to be Discontinued; Mitozytrex (Mitomycin for Injection) - updated Drug Shortages: Drugs to be Discontinued; Mitozytrex (Mitomycin for Injection) - updated
See information in Related Information section. Source: www.fda.gov Drug Shortages: Resolved Drug Shortages; Zanosar (Streptozocin) 1gm/vial Injection See Web site for additional information Source: www.fda.gov February 27, 2009Orange Book Orange Book
Approved Drug Products with Therapeutic Equivalence Evaluations Orange Book (updated) Source: www.fda.gov January First-Time Generic Drug Approvals Office of Generic Drugs: January First-Time Generic Drug Approvals Source: www.fda.gov Drug Safety Oversight Board Meetings Memorandum of Meeting Minutes, Drug Safety Oversight Board Meeting, January 15, 2009 Source: www.fda.gov Drug Shortages: Current Drug Shortages: Oxycodone Immediate Release Tablets (5mg, 15mg and 30mg) Mallinckrodt continues to work diligently to meet the market need during this temporary period of limited supply. Xanodyne has additional releases starting February 20th, 2009. Vintage Pharmaceuticals will be releasing additional product starting February 11th, 2009. Source: www.fda.gov Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS) between July - September 2008 Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS) between July - September 2008 Source: www.fda.gov February 26, 20092009 PDA/FDA Asia-Pacific Pharmaceutical Ingredient Supply Chain Conference, June 15-19, 2009, Shanghai, China 2009 PDA/FDA Asia-Pacific Pharmaceutical Ingredient Supply Chain Conference, June 15-19, 2009, Shanghai, China
The 2009 PDA/FDA Asia Pacific Pharmaceutical Ingredient Supply Chain Conference is jointly sponsored by PDA and the Shanghai Municipal FDA (SHFDA) as a result of a memorandum of understanding signed in September 2008. Source: www.pda.org BPCA/Pediatric Exclusivity Statistics BPCA/Pediatric Exclusivity Statistics (updated) Source: www.fda.gov Drug Shortages: Current Drug Shortages: Azactam 1 gram and 2 gram (aztreonam for injection) Elan estimates availability of Azactam 1 gram vials (NDC 51479-0041-15), and 2 gram vials (NDC 51479-0042-15)in March/April time frame. For additional information call Elan at 1-800-859-8586, and Baxter has 1 gram (NDC 51479-0048-01) and 2 gram (NDC 51479-0049-01) frozen aztreonam available on allocation. For additional information call Baxter at 1-888-229-0001. Source: www.fda.gov Guidance for Industry Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 8: Sterility Test General Chapter Source: www.fda.gov Drug Shortages: Current Drug Shortages: Oxycodone Immediate Release Tablets (5mg, 15mg and 30mg) Mallinckrodt continues to work diligently to meet the market need during this temporary period of limited supply. Xanodyne has additional releases starting February 20th, 2009. Vintage Pharmaceuticals will be releasing additional product starting February 11th, 2009. Source: www.fda.gov Drug Shortages: Current Drug Shortages; AMMONUL (sodium phenylacetate and sodium benzoate) Injection 10%/10% See information in Related Information section. Source: www.fda.gov Drug Shortages: Current Drug Shortages: Calcium Disodium Versenate Injection 200 mg/mL 5 mL ampules (NDC 00089-0510-06) Additional Information: FDA and Graceway are working to resolve the shortage as soon as possible. Source: www.fda.gov Drug Shortages: Drugs to be Discontinued; Nimotop (nimodipine) capsules See Web site for additional information Source: www.fda.gov BPCA of 2007: List of Determinations including Written Request Best Pharmaceuticals for Children Act of 2007: List of Determinations Including Written Request (updated) Source: www.fda.gov Listing of OTC Active Ingredients Listing of OTC Active Ingredients sorted by alphabetical and by monograph Source: www.fda.gov February 25, 2009Drug Shortages: Drugs to be Discontinued; Mitozytrex (Mitomycin for Injection) - updated Drug Shortages: Drugs to be Discontinued; Mitozytrex (Mitomycin for Injection) - updated
See information in Related Information section. Source: www.fda.gov Ethex Corporation Product Recall Nationwide voluntary recall of products at wholesale and retail level because they may have been manufactured under conditions that did not sufficiently comply with current Good Manufacturing Practices. Source: www.fda.gov Drug Shortages: Resolved Drug Shortages; Albuterol Metered Dose Inhalers and Levalbuterol Metered Dose Inhalers The transition from albuterol CFC MDIs to albuterol HFA MDIs is now complete and supplies of albuterol HFA and levalbuterol HFA MDIs continue to meet total market demand. Source: www.fda.gov Drug Shortages: Drugs to be Discontinued; SecreFlo (porcine secretin for injection, 16 mcg/vial) See Related information section Source: www.fda.gov Drug Shortages: Current Drug Shortages; Ultra-TechneKow DTE (Technetium Tc 99m Generator) NDA 17-243 See Related information section for updated Letter from Mallinckrodt Source: www.fda.gov February 24, 2009CellCept (mycophenolate mofetil) CellCept (mycophenolate mofetil)
Medication Guide issued, providing important safety information, to be distributed to every patient who fills a CellCept prescription from this point forward. Source: www.fda.gov Xigris (Drotrecogin alfa (activated)) - Early Communication about an Ongoing Safety Review FDA is evaluating a study showing increased incidence of serious bleeding events and mortality in patients who received Xigris. Source: www.fda.gov 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. Source: www.fda.gov Raptiva (efalizumab) Public Health Advisory describes rare brain condition, progressive multifocal leukoencephalopathy, associated with the use of Raptiva. Source: www.fda.gov Drug Shortages: Current Drug Shortages; Argatroban Injection See Related information section Source: www.fda.gov Drug Shortages: Current Drug Shortages: Amikacin sulfate injection Hospira has amikacin available; customer service: 877-946-7747. Teva anticipates their product will be available by the end of February 2009. Source: www.fda.gov A Guide to Safe Use of Pain Medicine How to use pain relief medicine safely and effectively. Source: www.fda.gov Drug Shortages: Current Drug Shortages; Vinblastine Sulfate Injection See Related information section for posted letter Source: www.fda.gov Clopidogrel bisulfate (marketed as Plavix) FDA to conduct safety review to evaluate differences in efffectiveness, genetic factors, potential drug interactions. Source: www.fda.gov 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. Source: www.fda.gov February 23, 2009FDA Approves Orphan Drug ATryn to Treat Rare Clotting Disorder FDA Approves Orphan Drug ATryn to Treat Rare Clotting Disorder
The U.S. Food and Drug Administration today issued its first approval for a biological product produced by genetically engineered (GE) animals. Source: www.fda.gov 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. Source: www.fda.gov Regulatory Meeting with Manufacturers and Users of Bisphenol A-containing Materials On Jan. 30, 2009, the U.S. Food and Drug Administration and Health Canada's Health Products and Food Branch hosted a meeting of representatives of U.S. and Canadian manufacturers and users of food packaging materials containing bisphenol A (BPA) to discuss what is being done to help minimize the levels of the chemical in food. The meeting was also part of FDA's efforts to assist industry in its voluntary BPA reduction efforts. Source: www.fda.gov January First-Time Generic Drug Approvals Office of Generic Drugs: January First-Time Generic Drug Approvals Source: www.fda.gov Drug Shortages: Current Drug Shortages: Mitomycin for injection See Related Information section Source: www.fda.gov FDA Approves Humanitarian Device Exemption for Deep Brain Stimulator for Severe Obsessive-Compulsive Disorder The U.S. Food and Drug Administration today approved a humanitarian device exemption for the first implantable device that delivers intermittent electrical therapy deep within the brain to suppress the symptoms associated with severe obsessive-compulsive disorder (OCD). Source: www.fda.gov FDA Warns Consumers Against Dietary Supplement Containing Undeclared Drug The 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. Source: www.fda.gov FDA Issues Early Communication about a Safety Review of Xigris FDA Issues Early Communication about a Safety Review of Xigris
The U.S. Food and Drug Administration today announced that it is working with the maker of Xigris (drotrecogin alfa activated), Eli Lilly and Company, to further evaluate the incidence of serious bleeding events and death in patients who receive Xigris, a drug used to treat severe sepsis (a blood stream infection). Source: www.fda.gov Topical Anesthetics Patients, healthcare professionals, and caregivers alerted to serious hazards of using skin numbing products for relieving pain from mammography and other medical tests and conditions, especially when applied to a large area of skin or when the area of application is covered. Source: www.fda.gov FDA Issues Guidances for Industry to Improve the Safety of Food, Feed and Drugs The U.S. Food and Drug Administration today issued three guidances designed to help ensure the safety of FDA-regulated products in the supply chain. Source: www.fda.gov FDA issues an Early Communication about an Ongoing Safety Review Xigris (Drotrecogin alfa [activated]) FDA issues an Early Communication about an Ongoing Safety Review Xigris (Drotrecogin alfa [activated])
FDA issues an Early Communication about an Ongoing Safety Review Xigris (Drotrecogin alfa [activated]) Source: www.fda.gov FDA, EPA and USDA Conclude That Accidental Release of Genetically Engineered Cotton Poses No Safety Risk to Humans or Animals The U.S. government announced today that there is no food or feed safety concern from an incident in which a small portion of an unauthorized genetically engineered (GE) cotton variety was harvested along with commercially available GE cotton. Source: www.fda.gov FDA Statement Following CHPA's Announcement on Nonprescription Over-the-Counter Cough and Cold Medicines in Children The steps that are being taken by CHPA will not affect the availability of the medicines, but this voluntary action will result in a transition period where the instructions for use of some OTC cough and cold medicines in children will be different from others. FDA does not typically request removal of OTC products with previous labeling from the shelves during a voluntary label change such as this one. Therefore, some medicines will have the new recommendation "do not use" for children under 4 years of age, while others will instruct that they not be used for children under 2 years of age. If parents or caregivers have or purchase a product that does not have the voluntarily-modified labeling, FDA recommends that they should adhere to the dosage instructions and warnings on the label that accompanies the medication. They should not, under any circumstances, give adult medications to children. If parents or caregivers have questions or are just not sure about how to use a product, they should consult with their doctor or pharmacist. Source: www.fda.gov FDA Licenses for Marketing New Therapy for Rare Genetic Disease The U.S. Food and Drug Administration today licensed for marketing the first product in the United States intended to protect people with hereditary angioedema (HAE), a rare and potentially life-threatening genetic disease. HAE affects about 6,000 to 10,000 individuals in the United States. Source: www.fda.gov February 22, 2009FDA, EPA and USDA Conclude That Accidental Release of Genetically Engineered Cotton Poses No Safety Risk to Humans or Animals FDA, EPA and USDA Conclude That Accidental Release of Genetically Engineered Cotton Poses No Safety Risk to Humans or Animals
The U.S. government announced today that there is no food or feed safety concern from an incident in which a small portion of an unauthorized genetically engineered (GE) cotton variety was harvested along with commercially available GE cotton. Source: www.fda.gov FDA Warns Consumers and Retailers of Botulism Risk from Ungutted, Salt-Cured Alewives (Gaspereaux) Fish The U.S. Food and Drug Administration is warning retailers and food service operators not to offer for sale ungutted, salt-cured alewives (also called gaspereaux fish) from Michel and Charles LeBlanc Fisheries Ltd., CAP-PELE, New Brunswick, Canada, because the fish may contain the Clostridium botulinum (C. botulinum) toxin. Consumers should not consume the product. Source: www.fda.gov FDA Issues Early Communication about a Safety Review of Xigris The U.S. Food and Drug Administration today announced that it is working with the maker of Xigris (drotrecogin alfa activated), Eli Lilly and Company, to further evaluate the incidence of serious bleeding events and death in patients who receive Xigris, a drug used to treat severe sepsis (a blood stream infection). Source: www.fda.gov FDA Announces Two Appointments Commissioner of Food and Drugs Andrew C. von Eschenbach, M.D., today announced the appointments of Lou Valdez as associate commissioner for international programs, and of Lori Davis as chief information officer. Source: www.fda.gov |
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