February 20, 2009Preventing Medical Errors: More Mix-ups between Propylthiouracil and Purinethol Preventing Medical Errors: More Mix-ups between Propylthiouracil and Purinethol
The Institute for Safe Medication Practices (ISMP) is warning about mix-ups between the trade name of one drug and the generic name of another. Purinethol® (mercaptopurine), is the trade name of a potent antimetabolite used in oncology. Propylthiou... Source: www.accessdata.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 FDA to Meet with Drug Companies about REMS for Certain Opioid Drugs FDA to Meet with Drug Companies about REMS for Certain Opioid Drugs Source: www.fda.gov Paragraph IV Patent Certifications Office of Generic Drugs: Paragraph IV Patent Certifications (updated) Source: www.fda.gov Recalls and Safety Alerts: Recall of ReliOn Insulin Syringes Covidien, formerly Tyco Health Care, has recalled one lot of ReliOn disposable insulin syringes because of mislabeling. Some of the U-40 syringes in this lot were mistakenly labeled as U-100 syringes. Patients using U-100 insulin could experience a... Source: www.accessdata.fda.gov Preventing Medical Errors: Drug Name Confusion Between Kuric and Carac The Institute for Safe Medication Practices (ISMP) recently reported on the potential for mix-ups between two topical creams: Kuric (ketoconazole) and Carac (fluorouracil). Kuric is used to treat fungal infections and seborrheic dermatitis. Carac ... Source: www.accessdata.fda.gov FDA Drug Safety Newsletter, Volume 2, Number 1, 2009 FDA Drug Safety Newsletter, Volume 2, Number 1, 2009 Source: www.fda.gov FDA Approves New Drug to Alleviate Moderate to Severe Pain FDA Approves New Drug to Alleviate Moderate to Severe Pain
The U.S. Food and Drug Administration has approved Tapentadol hydrochloride, an immediate-release oral tablet for the relief of moderate to severe acute pain. Source: www.fda.gov 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. Source: www.fda.gov FDA Approves Toviaz, a New Drug to Treat Overactive Bladder The U.S. Food and Drug Administration has approved a new drug to help patients suffering from overactive bladder (OAB). Toviaz (fesoterodine fumarate) works by relaxing the smooth muscle tissue of the bladder, thus reducing the urinary frequency, urge to urinate, and sudden urinary incontinence (leakage of urine), that are characteristic symptoms of OAB. Source: www.fda.gov Drug Shortages: Current Drug Shortages: Acyclovir Injection See website for additional information Source: www.fda.gov Drug Shortages: Resolved Drug Shortages; Argatroban Injection See Related information section Source: www.fda.gov FDA Announces Permanent Injunction Against Wilderness Family Naturals LLC The U.S. Food and Drug Administration today announced that Wilderness Family Naturals LLC of Silver Bay, Minn., and its owners have signed a consent decree that prohibits them from manufacturing and distributing any products with unapproved claims that the products cure, treat, mitigate or prevent diseases. Source: www.fda.gov Adverse Event Reporting System (AERS) Statistics(updated) Adverse Event Reporting System (AERS) Statistics(updated)
Adverse Event Reporting System (AERS) Statistics (updated) 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: internet-dev 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 Guidance for Industry Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act Source: www.fda.gov FDA issues Updated Safety Information about Raptiva (efalizumab). FDA issues Updated Safety Information about Raptiva (efalizumab). Source: www.fda.gov BPCA/Pediatric Exclusivity Statistics BPCA/Pediatric Exclusivity Statistics (updated) Source: www.fda.gov February 19, 2009FDA and International Serious Adverse Events Consortium Release First Data on Genetic Basis of Adverse Drug Events FDA and International Serious Adverse Events Consortium Release First Data on Genetic Basis of Adverse Drug Events
The first data offering health care professionals a better look into the genetic basis of certain types of adverse drug events was released today by the FDA and the International Serious Adverse Event Consortium (SAEC). The data are focused on the genetics associated with drug-induced serious skin rashes, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, and helps better predict an individual's risk of developing these reactions. Source: www.fda.gov February 18, 2009Final Guidance on Genetically Engineered Animals Final Guidance on Genetically Engineered Animals
After considering public comments, FDA has issued final guidance on its approach to regulating genetically engineered animals. Source: www.fda.gov 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 Botulism Risk From Ungutted, Salt-Cured Alewives Fish Consumers should not eat this product because it may contain Clostridium botulinum toxin. Source: www.fda.gov Drugs@FDA Downloadable Data Files (updated) Drugs@FDA Downloadable Data Files (updated)
Drugs@FDA Downloadable Data Files (updated) Source: www.fda.gov Guidance for Industry Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act Source: www.fda.gov Orange Book Approved Drug Products with Therapeutic Equivalence Evaluations Orange Book (updated) Source: www.fda.gov Drug Shortages: Resolved Drug Shortages; Vinblastine Sulfate Injection See Related information section Source: www.fda.gov BPCA/Pediatric Exclusivity Statistics BPCA/Pediatric Exclusivity Statistics (updated) Source: www.fda.gov FDA Small Pharmaceutical Business Assistance Educational Forum Public Workshop, April 23, 2009 FDA Small Pharmaceutical Business Assistance Educational Forum Public Workshop, April 23, 2009 Source: www.fda.gov February 17, 2009Using Over-the-Counter Cough and Cold Products in Children Using Over-the-Counter Cough and Cold Products in Children
FDA supports the voluntary actions of drug manufacturers to better inform consumers about the safe and effective use of over-the-counter cough and cold medicines in children. Source: www.fda.gov Understanding Antidepressant Medications Here's a look at the benefits and risks of antidepressants, medications that act on naturally-occurring brain chemicals. Source: www.fda.gov Generic Drug Roundup: February 2009 Here are some of the noteworthy generic drug approvals of 2008. Source: www.fda.gov 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. 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 Food Safety Tips for Healthy Holidays FDA gives consumers practical food safety tips to help prevent foodborne illness. Source: www.fda.gov Tainted Weight Loss Pills Flagged as Health Risks FDA has alerted consumers not to buy or use more than 25 weight-loss products. Source: www.fda.gov FDA Acts to Reduce Risk of Salmonella Infections Find out why pet turtles may be a health risk and how FDA is enforcing a ban on the small creatures. Source: www.fda.gov February 16, 2009Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS) between April - June 2008 Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS) between April - June 2008
Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS) between April - June 2008 Source: www.fda.gov Adverse Event Reporting System (AERS) Statistics(updated) Adverse Event Reporting System (AERS) Statistics (updated) Source: www.fda.gov 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... Source: www.accessdata.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: 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 Guidance for Industry S9 Nonclinical Evaluation for Anticancer Pharmaceuticals Source: www.fda.gov Drugs@FDA Downloadable Data Files (updated) Drugs@FDA Downloadable Data Files (updated)
Drugs@FDA Downloadable Data Files (updated) Source: www.fda.gov Drug Shortages: Resolved Drug Shortages: Alprostadil 0.5 mg/mL injection See Related Information section Source: www.fda.gov January First-Time Generic Drug Approvals Office of Generic Drugs: January First-Time Generic Drug Approvals Source: www.fda.gov Guidance for Industry Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 7: Dissolution 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 Guidance for Industry New Revised/Withdrawn List for 2009 Source: www.fda.gov Adverse Event Reporting System (AERS) Statistics(updated) Adverse Event Reporting System (AERS) Statistics (updated) Source: www.fda.gov Forum Conference - Cytokine Therapies: Novel Approaches for Clinical Indications, March 26 and 27, 2009, NYAS Conference Center, New York City, NY: This event is a public, two-day forum that will focus on the clinical use of cytokines and cytokines antagonists as therapeutic agents for the treatment of human diseases, including cancer and autoimmune disorders such as rheumatoid arthritis, multiple sclerosis and inflammatory bowel disease. Meeting Information. Source: www.nyas.org 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) Source: www.fda.gov Paragraph IV Patent Certifications Office of Generic Drugs: Paragraph IV Patent Certifications (updated) Source: www.fda.gov Using Over-the-Counter Cough and Cold Products in Children Using Over-the-Counter Cough and Cold Products in Children
FDA supports the voluntary actions of drug manufacturers to better inform consumers about the safe and effective use of over-the-counter cough and cold medicines in children. Source: www.fda.gov Drug Shortages: Drugs to be Discontinued; Mitozytrex (Mitomycin for Injection) See Web site for additional information. 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 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 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; Fentanyl transdermal patch See Related information section 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 Drug Shortages: Drugs to be Discontinued; Foscavir (foscarnet sodium) injection See Web site for additional information Source: www.fda.gov February 15, 2009Drug Shortages: Drugs to be Discontinued; Mitozytrex (Mitomycin for Injection) Drug Shortages: Drugs to be Discontinued; Mitozytrex (Mitomycin for Injection)
See Web site for additional information. Source: www.fda.gov Botulism Risk From Ungutted, Salt-Cured Alewives Fish Consumers should not eat this product because it may contain Clostridium botulinum toxin. Source: www.fda.gov FDA Beyond Our Borders FDA works beyond our borders to help keep products used by Americans safe - even when they are not made in America. Source: www.fda.gov Some Medications and Driving Don't Mix Some prescription and over-the-counter (OTC) medicines can cause reactions that may make it unsafe to drive. Source: www.fda.gov Food Safety Tips for Healthy Holidays FDA gives consumers practical food safety tips to help prevent foodborne illness. Source: www.fda.gov FDA Web Page on Salmonella and Peanut Butter Visit FDA's Web page on Salmonella Typhimurium for the latest product recalls and advice for consumers. 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 Drug Shortages: Drugs to be Discontinued; Cefotan (cefotetan injection)- updated See additional information in Related Information section. Source: www.fda.gov |
Subscribe to Posts [Atom]