May 28, 2009Drugs@FDA Downloadable Data Files (updated) Drugs@FDA Downloadable Data Files (updated)
Drugs@FDA Downloadable Data Files (updated) Source: www.fda.gov Simponi (golimumab) Risk of serious fungal infections associated with TNF-α blockers, including Simponi. Source: www.fda.gov 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 Guidance for Industry Guidance for Industry: Presenting Risk Information in Prescription Drug and Medical Device Promotion Source: www.fda.gov Guidance for Industry Integrated Summaries of Effectiveness and Safety: Location Within the Common Technical Document Source: www.fda.gov Memorandum of Meeting Minutes: Drug Safety Oversight Board Meetings Drug Safety Oversight Board Meetings: Public Summaries, April 16, 2009 Source: www.fda.gov Drug Shortages: Current Drug Shortages: Technetium Tc99m Generators (updated) Drug Shortages: Current Drug Shortages: Technetium Tc99m Generators (updated)
Current Drug Shortages: Technetium Tc99m Generators, See letter in Related Information Section Source: www.fda.gov Drug Shortages: Current Drug Shortages: Metoprolol succinate extended release tablets Current Drug Shortages: Metoprolol succinate extended release tablets, see updated letter in Related Information Section Source: www.fda.gov Drug Shortages: Resolved Drug Shortages: Amikacin sulfate injection Resolved Drug Shortages: Amikacin sulfate injection, No further supply issues are anticipated Source: www.fda.gov Drug Shortages: Current Drug Shortages: Azactam 1 gram and 2 gram (aztreonam for injection) 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: Current Drug Shortages: Methotrexate injection Current Drug Shortages: Methotrexate injection: Bedford Laboratories- manufacturing delays, Hospira- unable to meet demand, GeneraMedix- increase in demand and APP has product available. See Related Information section for more information Source: www.fda.gov Drug Shortages: Resolved Drug Shortages: Fentanyl transdermal patch (updated) Drug Shortages: Resolved Drug Shortages: Fentanyl transdermal patch (updated)
Resolved Drug Shortages: Fentanyl transdermal patch, See update in Company name for Teva, in the Related Information section Source: www.fda.gov Guidance for Industry Individual Product Bioequivalence Recommendations Source: www.fda.gov Drug Shortages: Current Drug Shortages: Acyclovir Injection See website for additional information Source: www.fda.gov May 27, 2009Drug Shortages: Current Drug Shortages: Cisplatin Injection 1mg/ml Drug Shortages: Current Drug Shortages: Cisplatin Injection 1mg/ml
Current Drug Shortages: Cisplatin Injection 1mg/ml, updated related 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 Drug Shortages: Current Drug Shortages: Nitrostat sublingual tablets (0.3 mg, 0.4 mg, and 0.6 mg) Follow-up Dear Healthcare Professional Letter added to the Related information section Source: www.fda.gov Guidance for Industry New Revised/Withdrawn List for 2009 Source: www.fda.gov Drug Shortages: Current Drug Shortages: Metoprolol succinate extended release tablets Current Drug Shortages: Metoprolol succinate extended release tablets, see updated letter in Related Information Section Source: www.fda.gov Drug Shortages: Current Drug Shortages: Methotrexate injection Current Drug Shortages: Methotrexate injection: Bedford Laboratories- manufacturing delays, Hospira- unable to meet demand, GeneraMedix- increase in demand and APP has product available. See Related Information section for more information Source: www.fda.gov The Scoop on Whole Grains The Scoop on Whole Grains
What are whole grains and how much should you eat? Source: www.fda.gov Warning on Hydroxycut Products FDA is warning consumers to stop using Hydroxycut products because of serious health risks. One death due to liver failure has been reported to the agency. Source: www.fda.gov Antiepileptic Drugs FDA approved updated labeling to warn about an increased risk of suicidal thoughts and behaviors. Source: www.fda.gov May 2009 Patient Safety News May 2009 Patient Safety News
Video news show for healthcare professionals, covering safety alerts, recalls, product approvals, and important tips on protecting patients. Source: www.fda.gov FDA Approves Samsca to treat Hyponatremia The U.S. Food and Drug Administration has approved Samsca tablets (tolvaptan) to treat hyponatremia, an abnormally low concentration of sodium in the blood. Source: www.fda.gov The Scoop on Whole Grains What are whole grains and how much should you eat? Source: www.fda.gov Tarceva (erlotinib) Dear Healthcare Professional letter issued to warn about GI perforation, exfoliative skin conditions and corneal perforation/ulceration. Source: www.fda.gov FDA 101: Health Fraud Awareness Learn how to spot health fraud and avoid it. Source: www.fda.gov Pistachio Recall Expanded On April 6, 2009, Setton Pistachio, Terra Bella, Calif., expanded its recall of pistachio products. Source: www.fda.gov Dietary Supplements Worth $1.3 Million Condemned and Forfeited to the United States Under Consent Decree At the request of the FDA, U.S. Marshals seized more than 23,300 bottles of three dietary supplement products distributed by LG Sciences LLC, of Brighton, Mich. The seized products were marketed for use by body builders and distributed on the Internet and in retail stores under the names Methyl 1-D, Methyl 1-D XL, and Formadrol Extreme XL. Source: www.fda.gov Antiepileptic Drugs FDA approved updated labeling to warn about an increased risk of suicidal thoughts and behaviors. Source: www.fda.gov President's FY 2010 Budget for FDA Invests Substantially in Food and Medical Product Safety The U.S. Food and Drug Administration, part of the U.S. Department of Health and Human Services, is requesting a budget of $3.2 billion to protect and promote the public health as part of the President's fiscal year (FY) 2010 budget - a 19 percent increase over the current FDA fiscal year budget. Source: www.fda.gov Guidance for Industry Guidance for Industry
Label Comprehension Studies for Nonprescription Drug Products Source: www.fda.gov Drug Shortages: Current Drug Shortages: Morphine Sulfate Oral Solution (updated) Current Drug Shortages: Morphine Sulfate Oral Solution, See updated Dear Healthcare Provider Letter in the Related Information section Source: www.fda.gov Testosterone Gel Safety Information Testosterone Gel Safety Concerns Prompt FDA to Require Label Changes, Medication Guide Source: www.fda.gov Drug Shortages: Current Drug Shortages: Cisplatin Injection 1mg/ml (updated) Current Drug Shortages: Cisplatin Injection 1mg/ml : See updated Related Information Section for Teva Source: www.fda.gov Drug Shortages: Current Drug Shortages: Metoprolol succinate extended release tablets (updated) Current Drug Shortages: Metoprolol succinate extended release tablets: See updated letter in Related Information Section Source: www.fda.gov Agenda for the May 27 - 28, 2009 Opioid REMS Public Meeting Agenda for the May 27 - 28, 2009 Opioid REMS Public Meeting Source: www.fda.gov CDER Organization Charts CDER Organization Charts (updated) Source: www.fda.gov Recalls and Safety Alerts: Burns from Medicated Patches during MRI Exams FDA is warning healthcare professionals and patients that medicated patches with metallic backings can cause skin burns during MRI exams. These patches include both prescription and OTC products, including nicotine patches. The metallic backings ar... Source: www.accessdata.fda.gov May 26, 2009Drug Shortages: Current Drug Shortages: Mitomycin for injection (updated) Drug Shortages: Current Drug Shortages: Mitomycin for injection (updated)
Current Drug Shortages: Mitomycin for injection: See updated Related Information Section Source: www.fda.gov Drug Shortages: Current Drug Shortages: Metoprolol succinate extended release tablets See Related information section for updated letter Source: www.fda.gov Drug Shortages: Current Drug Shortages: Mitomycin for injection (updated) Current Drug Shortages: Mitomycin for injection: Ben Venue is shipping product, with allocation in effect, customer service: 1-800-562-4797 Source: www.fda.gov Drug Shortages: Current Drug Shortages: Nitrostat sublingual tablets (0.3 mg, 0.4 mg, and 0.6 mg) Drug Shortages: Current Drug Shortages: Nitrostat sublingual tablets (0.3 mg, 0.4 mg, and 0.6 mg)
See Related Information section Source: www.fda.gov Drug Shortages: Current Drug Shortages: Technetium Tc99m Generators Current Drug Shortages: Technetium Tc99m Generators, Reduced supply due to material sourcing issues, Covidien: 1-888-744-1414 (Ultra-Technekow DTE, NDA 17-243) and Lantheus: 1-800-299-3431 (Technelite, NDA 17-771) 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 Drug Shortages: Current Drug Shortages; Ultra-TechneKow DTE (Technetium Tc 99m Generator) NDA 17-243 (updated) Updated letter on this current drug shortage Source: www.fda.gov May 25, 2009Drug Shortages: Resolved Drug Shortages; Albuterol Metered Dose Inhalers and Levalbuterol Metered Dose Inhalers 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: Resolved Drug Shortages; Vinblastine Sulfate Injection See Related information section Source: www.fda.gov Drug Shortages: Current Drug Shortages: Dexrazoxane for Injection, Zinecard Current Drug Shortages: Dexrazoxane for Injection, Zinecard, Manufacturing delays, Totect remains in limited availability, labeled for use in treatment of extravasation resulting from IV anthracycline chemotherapy. TopoTarget inquiries: 1-866-470-8247 Source: www.fda.gov 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 Source: www.fda.gov Drug Shortages: Resolved Drug Shortages; Proglycem (diazoxide) oral suspension See Web site for additional information Source: www.fda.gov May 24, 2009Drug Shortages: Resolved Drug Shortages: Leucovorin Calcium Solution for Injection Drug Shortages: Resolved Drug Shortages: Leucovorin Calcium Solution for Injection
Resolved Drug Shortages: Leucovorin Calcium Solution for Injection, see Related Information Section Source: www.fda.gov Drug Shortages: Current Drug Shortages: Metoprolol succinate extended release tablets Current Drug Shortages: Metoprolol succinate extended release tablets, see updated letter in Related Information Section Source: www.fda.gov Drug Shortages: Current Drug Shortages: Cisplatin Injection 1mg/ml (updated) Current Drug Shortages: Cisplatin Injection 1mg/ml : See updated Related Information Section for Teva Source: www.fda.gov 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 Source: www.fda.gov Drug Shortages: Resolved Drug Shortages; MVI Adult Injectable No further supply issues are anticipated Source: www.fda.gov |
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