April 4, 2009Guidance for Industry Guidance for Industry
Newly Added Bioequivalence Recommendations Source: www.fda.gov Drug Shortages: Current Drug Shortages: Metoprolol succinate extended release tablets Drug Shortages: Current Drug Shortages: Metoprolol succinate extended release tablets, see Related Information Secrion for updated letter Source: www.fda.gov FDA: Insulin Pens and Insulin Cartridges Must Not Be Shared The U.S. Food and Drug Administration today issued an alert to health care professionals reminding them that single-patient insulin pens and insulin cartridges should not be used to administer medication to multiple patients due to the potential risk of transmitting blood-borne pathogens such as HIV and the hepatitis viruses. Source: www.fda.gov FDA Issues Guidance for Food Manufacturers on Use of Peanut-Derived Product The U.S. Food and Drug Administration recommends that manufacturers obtain any peanut-derived ingredient only from suppliers who use production processes that have been demonstrated to adequately reduce the presence of Salmonella species (Salmonella spp.), or that they ensure that their own manufacturing process would adequately reduce the presence of Salmonella species. Source: www.fda.gov Manual of Policies and Procedures Procedures and Responsibilities for Developing Postmarketing Requirements and Commitments Source: www.fda.gov April 3, 2009Drug Shortages: Current Drug Shortages: Oxycodone Immediate Release Tablets (5mg, 15mg and 30mg) - (updated) Drug Shortages: Current Drug Shortages: Oxycodone Immediate Release Tablets (5mg, 15mg and 30mg) - (updated)
Increase in demand related to product recalls by other manufacturers 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 February 2009 Safety 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 Drug Shortages: Resolved Drug Shortages; Zanosar (Streptozocin) 1gm/vial Injection See Web site for additional information Source: www.fda.gov Drug Shortages: Resolved Drug Shortages; Fentanyl transdermal patch See Related information section Source: www.fda.gov Myfortic (mycophenolic acid) Healthcare professionals notified of new Myfortic Medication Guide to provide important safety information for patients. Source: www.fda.gov Drug Shortages: Current Drug Shortages; Levoleucovorin (Fusilev) 50 mg single use vials See Web site for additional information Source: www.fda.gov 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 Source: www.fda.gov Drug Shortages: Resolved Drug Shortages; Proglycem (diazoxide) oral suspension See Web site for additional information Source: www.fda.gov Drug Shortages: Current Drug Shortages: Triamcinolone Hexacetonide (Aristospan) Drug Shortages: Current Drug Shortages: Triamcinolone Hexacetonide (Aristospan)
Triamcinolone Hexacetonide (Aristospan); Manufacturing Delays Source: www.fda.gov Drugs@FDA Downloadable Data Files (updated) Drugs@FDA Downloadable Data Files (updated) Source: www.fda.gov FDA Warns Against Consuming Peanuts and Peanut Products Sold by Westco Fruit and Nuts Inc. The U.S. Food and Drug Administration (FDA) is warning consumers not to consume any peanuts or peanut-derived products sold by Irvington, New Jersey-based Westco Fruit and Nuts Inc. (Westco/Westcott) due to possible Salmonella contamination. Peanuts in such products may have been distributed by the Peanut Corporation of America (PCA), which recalled the peanuts because of concern about Salmonella contamination. 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 April 2, 2009FDA Approves Drug for an Advanced Form of Kidney Cancer FDA Approves Drug for an Advanced Form of Kidney Cancer
The U.S. Food and Drug Administration today approved Afinitor oral tablets (everolimus) for the treatment of patients with advanced kidney cancer whose disease has progressed after treatment with other cancer therapies. Source: www.fda.gov FDA Warns Consumers About Potentially Contaminated Cheese The U.S. Food and Drug Administration is warning consumers not to eat Queso Fresco Fresh Cheese Mexican style soft cheese (two specific lots) or any Queso Cotija Molido Mexican style grated cheese manufactured and distributed by Peregrina Cheese Corp. of New York City. These products could be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in pregnant women, young children, frail or elderly people, and others with weakened immune systems. Source: www.fda.gov Myfortic (mycophenolic acid) Healthcare professionals notified of new Myfortic Medication Guide to provide important safety information for patients. Source: www.fda.gov Weight Loss Products UPDATE - FDA expanded its nationwide alert to consumers about tainted weight loss products containing undeclared, active pharmaceutical ingredients. Source: www.fda.gov Drug Shortages: Resolved Drug Shortages: Ultra-TechneKow DTE (Technetium Tc 99m Generator) NDA 17-243 Drug Shortages: Resolved Drug Shortages: Ultra-TechneKow DTE (Technetium Tc 99m Generator) NDA 17-243
No further supply issues are anticipated. See related information section for more information 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: 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: 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: 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: 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: Drugs to be Discontinued; SecreFlo (porcine secretin for injection, 16 mcg/vial) See Web site for additional information Source: www.fda.gov Recalls and Safety Alerts: Limitations of Skin Patch Testing for Diagnosing Hypersensitivity Reactions with Abacavir FDA is cautioning healthcare professionals against using skin patch testing to immunologically confirm suspected cases of hypersensitivity reaction in patients treated with the antiretroviral drug abacavir. Abacavir is sold under the trade name Ziag... Source: www.accessdata.fda.gov Patients Are Asking: Caution Using Topical Anesthetics Prior to Mammography FDA is alerting patients and healthcare professionals about the potential danger of using topical anesthetics to relieve pain before having mammography or other medical procedures. The concern is that patients may apply these drugs improperly, which... Source: www.accessdata.fda.gov Recall of Certain Pistachios Recall of Certain Pistachios
FDA recommends that consumers avoid eating pistachio products until more information is available about the scope of affected products. Source: www.fda.gov Drug Shortages: Resolved Drug Shortages; Zanosar (Streptozocin) 1gm/vial Injection See Web site for additional information Source: www.fda.gov Drug Shortages: Current Drug Shortages; Argatroban Injection See Related information section Source: www.fda.gov Drug Shortages: Current Drug Shortages: Leucovorin Calcium Solution for Injection (updated) Drug Shortages: Current Drug Shortages: Leucovorin Calcium Solution for Injection 10 mg/mL, Preservative Free, 50 mL vial, package of 1; 50 mL Novaplus vial, package of 1: Manufacturing Delays Source: www.fda.gov FDA Approves New Vaccine to Prevent Japanese Encephalitis The U.S. Food and Drug Administration today approved IXIARO, a vaccine to prevent Japanese encephalitis (JE) which is caused by a mosquito-transmitted virus found mainly in Asia. IXIARO will be the only vaccine for JE available in the United States. Source: www.fda.gov 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 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 FDA Acts to Halt Marketing of Certain Unapproved Prescription Narcotic Drugs The U.S. Food and Drug Administration today warned nine companies to stop manufacturing 14 unapproved narcotic drugs that are marketed in several dosage forms and are widely used to treat pain. Source: www.fda.gov Drug Shortages: Current Drug Shortages; Vinblastine Sulfate Injection See Web site for additional information Source: www.fda.gov FDA Warns Consumers About Potentially Contaminated Cheese The U.S. Food and Drug Administration is warning consumers not to eat Queso Fresco Fresh Cheese Mexican style soft cheese (two specific lots) or any Queso Cotija Molido Mexican style grated cheese manufactured and distributed by Peregrina Cheese Corp. of New York City. These products could be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in pregnant women, young children, frail or elderly people, and others with weakened immune systems. Source: www.fda.gov April 1, 2009FDA Alerts Consumers to Recall of Certain Pistachios FDA Alerts Consumers to Recall of Certain Pistachios
The FDA and the California Department of Public Health (CDPH) are investigating Salmonella contamination in pistachio products sold by Setton Pistachio of Terra Bella Inc, Calif. The company has stopped all distribution of processed pistachios and will issue a voluntary recall involving approximately 1 million pounds of its products. Source: www.fda.gov On the Road Again: FDA's Mobile Laboratories This article (with slide show) reveals how mobile labs help FDA test food and drugs for contaminants. Source: www.fda.gov FDA and Eight Academic and Research Institutions to Collaborate Under Nanotechnology Initiative The U.S. Food and Drug Administration today unveiled a new collaboration initiative with the Houston-based Alliance for NanoHealth (ANH) and its eight member institutions to help speed development of safe and effective medical products in the emerging field of nanotechnology. 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 FDA Approves Drug for an Advanced Form of Kidney Cancer The U.S. Food and Drug Administration today approved Afinitor oral tablets (everolimus) for the treatment of patients with advanced kidney cancer whose disease has progressed after treatment with other cancer therapies. Source: www.fda.gov FDA Approves Generic Topamax to Prevent Seizures The U.S. Food and Drug Administration has approved the first generic versions of Topamax tablets (topiramate) to prevent seizures. Source: www.fda.gov Clinical Trial Design for Hospital-Acquired Pneumonia and Ventilator-Associated Pneumonia; Public Workshop, March 31, 2009 and April 1, 2009, Silver Spring, Maryland (updated) Clinical Trial Design for Hospital-Acquired Pneumonia and Ventilator-Associated Pneumonia; Public Workshop, March 31, 2009 and April 1, 2009, Silver Spring, Maryland; see updated Agenda Source: www.fda.gov FDA Approves New Vaccine to Prevent Japanese Encephalitis The U.S. Food and Drug Administration today approved IXIARO, a vaccine to prevent Japanese encephalitis (JE) which is caused by a mosquito-transmitted virus found mainly in Asia. IXIARO will be the only vaccine for JE available in the United States. Source: www.fda.gov FDA Approved First DNA Test for Two Types of Human Papillomavirus The test, called Cervista HPV 16/18, detects the DNA sequences for HPV type 16 and HPV type 18 in cervical cells. Differentiating these HPV types gives health care professionals more information on a patient's risk of subsequently developing cervical cancer. Source: www.fda.gov Clinical Trial Design for Hospital-Acquired Pneumonia and Ventilator-Associated Pneumonia; Public Workshop, March 31, 2009 and April 1, 2009, Silver Spring, Maryland (updated) Clinical Trial Design for Hospital-Acquired Pneumonia and Ventilator-Associated Pneumonia; Public Workshop, March 31, 2009 and April 1, 2009, Silver Spring, Maryland (updated)
Clinical Trial Design for Hospital-Acquired Pneumonia and Ventilator-Associated Pneumonia; Public Workshop, March 31, 2009 and April 1, 2009, Silver Spring, Maryland; see updated Agenda Source: www.fda.gov Drug Shortages: Current Drug Shortages; Argatroban Injection See Related information section Source: www.fda.gov Public Workshop on Developing a Consolidated Pediatric Rheumatology Observational Registry Public Workshop on Developing a Consolidated Pediatric Rheumatology Observational Registry; May 12-13, 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 March 31, 2009FDA Acts to Halt Marketing of Certain Unapproved Prescription Narcotic Drugs FDA Acts to Halt Marketing of Certain Unapproved Prescription Narcotic Drugs
The U.S. Food and Drug Administration today warned nine companies to stop manufacturing 14 unapproved narcotic drugs that are marketed in several dosage forms and are widely used to treat pain. Source: www.fda.gov On the Road Again: FDA's Mobile Laboratories This article (with slide show) reveals how mobile labs help FDA test food and drugs for contaminants. Source: www.fda.gov Clinical Trial Design for Hospital-Acquired Pneumonia and Ventilator-Associated Pneumonia Public Workshop, March 31, 2009 and April 1, 2009, Silver Spring, Maryland (updated) Clinical Trial Design for Hospital-Acquired Pneumonia and Ventilator-Associated Pneumonia Public Workshop, March 31, 2009 and April 1, 2009, Silver Spring, Maryland (updated)
See Web site for updated information Source: www.fda.gov FDA Assessing Feasibility of Using Nanotechnology Test to Detect Anthrax Following a Bioterrorist Attack The U.S. Food and Drug Administration has completed a "proof-of-concept" study of a test that quickly and accurately detects the presence of even the smallest amount of the deadly anthrax toxin. Source: www.fda.gov Manual of Policies and Procedures Procedures and Responsibilities for Developing Postmarketing Requirements and Commitments Source: www.fda.gov Pediatric Exclusivity Granted BPCA/Pediatric Exclusivity Statistics: Pediatric Exclusivity Granted(updated) Source: www.fda.gov Drug Shortages: Current Drug Shortages: Oxycodone Immediate Release Tablets (5mg, 15mg and 30mg) - (updated) Increase in demand related to product recalls by other manufacturers Source: www.fda.gov Propafenone HCL Tablets Recall due to oversized tablets and risk of serious side effects. Source: www.fda.gov March 30, 2009Drug Shortages: Current Drug Shortages: Amikacin sulfate injection 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; AMMONUL (sodium phenylacetate and sodium benzoate) Injection 10%/10% See information in Related Information section. Source: www.fda.gov Drug Shortages: Current Drug Shortages: Cisplatin Injection 1mg/ml (updated) Drug Shortages: Current Drug Shortages: Cisplatin Injection 1mg/ml: See Related Information Section Source: www.fda.gov Drug Shortages: Current Drug Shortages: Cisplatin Injection 1mg/ml (updated) Drug Shortages: Current Drug Shortages: Cisplatin Injection 1mg/ml (updated)
Drug Shortages: Current Drug Shortages: Cisplatin Injection 1mg/ml: See Related Information Section Source: www.fda.gov FDA Approved First DNA Test for Two Types of Human Papillomavirus The test, called Cervista HPV 16/18, detects the DNA sequences for HPV type 16 and HPV type 18 in cervical cells. Differentiating these HPV types gives health care professionals more information on a patient's risk of subsequently developing cervical cancer. Source: www.fda.gov February First-Time Generic Drug Approvals Office of Generic Drugs: February First-Time Generic Drug Approvals Source: www.fda.gov March 29, 2009Clinical Trial Design for Hospital-Acquired Pneumonia and Ventilator-Associated Pneumonia; Public Workshop, March 31, 2009 and April 1, 2009, Silver Spring, Maryland (updated) Clinical Trial Design for Hospital-Acquired Pneumonia and Ventilator-Associated Pneumonia; Public Workshop, March 31, 2009 and April 1, 2009, Silver Spring, Maryland (updated)
Clinical Trial Design for Hospital-Acquired Pneumonia and Ventilator-Associated Pneumonia; Public Workshop, March 31, 2009 and April 1, 2009, Silver Spring, Maryland; see updated Agenda Source: www.fda.gov Rulemaking History for Nonprescription Products Office of Nonprescription Products: Rulemaking History for Nonprescription Products (updated) Source: www.fda.gov |
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