What's New (Drugs)

September 17, 2012

• Drug Firm Annual Registration Status Download File (updated)
• Drug Firm Annual Registration Status (updated) 

September 14, 2012

• FDA Drug Safety Podcast: Rare cases of serious burns with the use of over-the-counter topical muscle and joint pain relievers
• Drug Firm Annual Registration Status Download File (updated)
• Drug Firm Annual Registration Status (updated) 
• Medication Guides (updated)

September 13, 2012

• Current Drug Shortages Index (updated)
• Drug Firm Annual Registration Status Download File (updated)
• Drug Firm Annual Registration Status (updated)
• Drugs@FDA Download File (updated)
• FDA Drug Safety Communication: Rare cases of serious burns with the use of over-the-counter topical muscle and joint pain relievers
• FDA approves Aubagio (teriflunomide), a o­nce-a-day tablet for the treatment of adults with relapsing forms of multiple sclerosis (MS)
• FDA approves the production and use of Choline C 11 Injection, a Positron Emission Tomography (PET) imaging agent used to help detect recurrent prostate cancer
• Prescription Drug User Fee Act (PDUFA):
• Standard Costs (in thousands of dollars) for Components of the Process for the Review of Human Drug Applications (updated to incorporate FY 2011 standard costs)
• Standard Costs (in thousands of dollars) for Components of the Process for the Review of Human Drug Applications (updated to incorporate FY 2011 standard costs) (PDF version - 14KB)
• Federal Register Notice: Fee for Using a Priority Review Voucher in FY 2013 (PDF - 191KB)
• Spanish FDA Drug Safety Communication: Comunicado de la FDA sobre la seguridad de los medicamentos: Casos poco comunes de quemaduras graves con el uso de analgésicos tópicos de venta libre para el dolor muscular y articular

September 12, 2012

• Approved Risk Evaluation and Mitigation Strategies (REMS) (updated)
• Drug Development for Myalgic Encephalomyelitis and Chronic Fatigue Syndrome (ME/CFS), September 13, 2012, Teleconference. Meeting information
• Drug Firm Annual Registration Status Download File (updated)
• Drug Firm Annual Registration Status (updated)
• MedWatch Safety Alert: Qualitest Hydrocodone Bitartrate and Acetaminophen Tablets 10 mg/500 mg: Recall - Potential for Oversized Tablets

September 11, 2012

• Current Drug Shortages Index (updated)
• Current Drug Shortages: Bacteriostatic 0.9% Sodium Chloride
• Drug Firm Annual Registration Status Download File (updated)
• Drug Firm Annual Registration Status (updated)
• Pediatric Exclusivity Statistics (updated)

September 10, 2012

• FDA Drug Safety Podcast: FDA recommends against use of Revatio in children with pulmonary hypertension
• Drug Firm Annual Registration Status Download File (updated)
• Drug Firm Annual Registration Status (updated)
• National Drug Code Directory (updated)
• Unwrapping FDA’s 2012 UFA Package: What’s Inside the Statute, What’s Next?, September 20, 2012, The Westin Washington D.C.. City Center, 1400 M Street NW Washington, DC. Meeting information and registration  

September 6, 2012

• Drug Firm Annual Registration Status Download File (updated)
• Drug Firm Annual Registration Status (updated)
• National Drug Code Directory (updated) 
• Warning Letters 2012 (updated)
• Current Drug Shortages Index (updated)
• Drug Firm Annual Registration Status Download File (updated)
• Drug Firm Annual Registration Status (updated)
• Pediatric Statistics: Pediatric Exclusivity Granted (updated)

September 5, 2012

• Current Drug Shortages Index (updated)
• Drug Firm Annual Registration Status Download File (updated)
• Drug Firm Annual Registration Status (updated)
• Drugs@FDA Download File (updated)
• MedWatch Safety Alert: Nimodipine: Recall - Crystallization of Fill Material
• Spanish FDA Drug Safety Communication: Revatio: La FDA recomienda que no se use Revatio en niños con hipertensión pulmonar

·Electronic Common Technical Document (eCTD) Module 1 (updated)

September 4, 2012

• Drug Firm Annual Registration Status Download File (updated)
• Drug Firm Annual Registration Status (updated)
• National Drug Code Directory (updated) 
• Paragraph IV Patent Certifications (updated)

August 31, 2012

• Drug Firm Annual Registration Status Download File (updated)
• Drug Firm Annual Registration Status (updated)
• FDA approves Xtandi (enzalutamide), a new treatment for a type of late stage prostate cancer

August 30, 2012

• FDA Drug Safety Communication: FDA recommends against use of Revatio in children with pulmonary hypertension
• FDA grants accelerated approval to Afinitor Disperz, a new pediatric formulation of everolimus  

August 29, 2012

• Drug Firm Annual Registration Status Download File (updated)
• Drug Firm Annual Registration Status (updated)
• Drugs@FDA Download File (updated)
• FDA Notification to the Cystic Fibrosis Community o­n Kalydeco (ivacaftor)
• Natural Disaster Response (updated) 

August 28, 2012

• CDER Director's Mailbag: Question o­n Biosimilars
• Current Drug Shortages Index (updated)
• Current Drug Shortages: Pentamidine isethionate inhalant (NebuPent)
• Current Drug Shortages: Pentamidine isethionate for injection (Pentam 300)
• FDA approves Stribild (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate), a new combination pill for HIV treatment for some patients
• Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (FDASIA)

August 27, 2012

• Drug Firm Annual Registration Status Download File (updated)
• Drug Firm Annual Registration Status (updated)
• Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (FDAAA) (updated)
• National Drug Code Directory (updated) 

August 24, 2012

• Current Drug Shortages Index (updated)
• Drug Firm Annual Registration Status Download File (updated)
• Drug Firm Annual Registration Status (updated)
• National Drug Code Directory (updated)

August 23, 2012

• Approved Risk Evaluation and Mitigation Strategies (REMS) (updated)
• Current Drug Shortages Index (updated)
• Drug Firm Annual Registration Status Download File (updated)
• Drug Firm Annual Registration Status (updated)
• Guidance for Industry:
• Generic Drug: User Fee Amendments of 2012: Questions and Answers (PDF - 482KB)
• Self-Identification of Generic Drug Facilities, Sites, and Organizations (PDF - 209KB)

August 22, 2012

• Current Drug Shortages Index (updated)
• Drug Firm Annual Registration Status Download File (updated)
• Drug Firm Annual Registration Status (updated)
• Drugs@FDA Download File (updated)
• FDA's Clinical Investigator Training Course, November 13-15, 2012. College Park, MD. This course is designed for physicians, nurses, pharmacists and other health care professionals involved in clinical trials. Meeting information and registration  
• Spanish FDA Drug Safety Communication: El uso de codeína en ciertos niños tras amigdalectomía y/o adenoidectomía puede llevar a eventos adversos poco comunes pero que pueden poner en peligro la vida o causar la muerte

August 21, 2012

• Drug Firm Annual Registration Status Download File (updated)
• Drug Firm Annual Registration Status (updated)
• FDA Drug Info Rounds: Patents and Exclusivity
• Paragraph IV Patent Certifications (updated)

August 20, 2012

• Questions and Answers: Reumofan Plus and Reumofan Plus Premium
• Office of Scientific Investigations (OSI) Metrics Overview (updated)
• Current Drug Shortages Index (updated)
• Current Drug Shortages: Succinylcholine Injection
• Drug Firm Annual Registration Status Download File (updated)
• Drug Firm Annual Registration Status (updated)
• Medication Guides (updated)
• National Drug Code Directory (updated)

August 17, 2012

• FDA approves first generic Actos (pioglitazone hydrochloride) to treat type 2 diabetes
• FDA MedWatch Safety Alert: Hospira Propofol Injectable Emulsion: Recall - Glass Vial Defect

August 16, 2012

• FDA Drug Safety Podcast: Codeine use in certain children after tonsillectomy and/or adenoidectomy may lead to rare, but  life-threatening adverse events or death
• Drug Firm Annual Registration Status Download File (updated)
• Drug Firm Annual Registration Status (updated)
• MedWatch Safety Alert: Hospira Hydromorphone Hydrochloride Injection 2 MG/ML, 1 mL fill in 2.5 mL Carpuject: Recall- May Contain More Than The Intended Fill Volume
• Orange Book updates
• Additions/Deletions for Prescription and OTC Drug Product Lists
• Orange Book Current Cumulative Supplement (PDF - 1.4MB)
• Orange Book Data Files (compressed) (ZIP - 533KB)
• Prescription Drug User Fee Act (PDUFA) (updated): The FY 2013 Product and Establishment Fee Invoices were mailed Wednesday, August 15, 2012. Full payment of the invoice is due October 1, 2012. If you do not receive your invoice by August 27, 2012, please contact Ashley Jones or Beverly Friedman at 301-796-3602.

August 15, 2012

• Drug Firm Annual Registration Status Download File (updated)
• Drug Firm Annual Registration Status (updated)
• Drug Safety Communication: Codeine use in certain children after tonsillectomy and/or adenoidectomy may lead to rare, but life-threatening adverse events or death
• Drugs@FDA Download File (updated)

August 14, 2012

• FDA Small Business Regulatory Education for Industry (REdI) Conference Fall 2012, September 19-20, 2012, Washington Marriott Wardman Park, Washington, DC. Meeting Information
• Drug Firm Annual Registration Status Download File (updated)
• Drug Firm Annual Registration Status (updated)
• Drug Shortages: Current Drug Shortages: Atracurium besylate (updated)
• Drug Shortages: Current Drug Shortages: Aquasol A (updated)
• Drug Shortages: Current Drug Shortages: Acetylcysteine Inhalation Solution (updated)
• Drug Shortages: Current Drug Shortages: Ammonium Chloride Injection (updated)
• Drug Shortages: Current Drug Shortages: Amphetamine Mixed Salts Immediate-Release Tablets (updated)
• Drug Shortages: Current Drug Shortages: Bumetanide Injection (updated)
• Drug Shortages: Current Drug Shortages: Bupivacaine Hydrochloride Injection (updated)
• Drug Shortages: Current Drug Shortages: Butorphanol Injection (updated)
• Drug Shortages: Current Drug Shortages: Desmopressin Injection (updated)
• Drug Shortages: Current Drug Shortages: Dextroamphetamine Tablets (updated)
• Drug Shortages: Current Drug Shortages: Diazepam Injection (updated)
• Drug Shortages: Current Drug Shortages: Epinephrine Injection (updated)
• Drug Shortages: Current Drug Shortages: Etomidate Injection (updated)
• Drug Shortages: Current Drug Shortages: Fentanyl Citrate Injection (updated
• Drug Shortages: Current Drug Shortages: Furosemide Injection (updated)
• Drug Shortages: Current Drug Shortages: Hydromorphone Hydrochloride Injection (updated)
• Drug Shortages: Current Drug Shortages: Isoniazid Tablets (updated)
• Drug Shortages: Current Drug Shortages: Methotrexate Injection (updated)
• Drug Shortages: Current Drug Shortages: Nefazodone Tablets (updated)
• Drug Shortages: Current Drug Shortages: Lidocaine HCL, 4% Topical Solution (updated)
• Drug Shortages: Current Drug Shortages: Lorazepam Injection (updated)
• Drug Shortages: Current Drug Shortages: Magnesium Sulfate Injection (updated)
• Drug Shortages: Current Drug Shortages: Methotrexate Injection (updated)
• Drug Shortages: Current Drug Shortages: Morphine Sulfate Injection (updated)
• Drug Shortages: Current Drug Shortages: Naloxone Injection (updated)
• Drug Shortages: Current Drug Shortages: o­ndansetron Injection 2 mg/mL (updated)
• Drug Shortages: Current Drug Shortages: Pentostatin for Injection (Nipent) (updated)
• Drug Shortages: Current Drug Shortages: Potassium Chloride Injection 2 mEq/mL (updated)
• Drug Shortages: Current Drug Shortages: Procainamide HCL Injection (updated)
• Drug Shortages: Current Drug Shortages: Propofol Injection (updated)
• Drug Shortages: Current Drug Shortages: Sodium Acetate Injection (updated)
• Drug Shortages: Current Drug Shortages: Sodium Bicarbonate Injection (updated)
• Drug Shortages: Current Drug Shortages: Ticlopidine Tablets (updated)
• Drug Shortages: Current Drug Shortages: Viaspan Cold Storage Solution 1000 mL Bag (updated)
• Drug Shortages: Current Drug Shortages: Zinc Injection (updated)
• Guidance for Industry:  Suicidal Ideation and Behavior: Prospective Assessment of Occurrence in Clinical Trials

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