FDA What's New: Drugs

New and Generic Drug Approvals

Drug Approval Listing

Kategorien: Quellen, Sicherheitsinformationen - Arzneimittel und Medizinprodukte

Comunicado de la FDA sobre la seguridad de los medicamentos: Informe actualizado sobre la seguridad del medicamento Revlimid (lenalidomida) para el cáncer y el riesgo de nuevos tipos de neoplasias (nuevos tipos de cáncer)

El 7 de mayo del 2012, la Administración de Alimentos y Medicamentos de Estados Unidos (FDA por sus siglas en inglés) informó al público sobre el aumento en el riesgo de segundas neoplasias primarias (nuevos tipos de cáncer) en pacientes con mieloma múltiple de reciente diagnóstico, que tomaron Revlimid (lenalidomida).

Kategorien: Quellen, Sicherheitsinformationen - Arzneimittel und Medizinprodukte

Updated Questions and Answers for Healthcare Professionals and the Public: Use an Approved Pancreatic Enzyme Product (PEP)

FDA has updated questions and answers about the safe use of approved pancreatic enzyme products.

Kategorien: Quellen, Sicherheitsinformationen - Arzneimittel und Medizinprodukte

Newly Added Guidance Documents

Kategorien: Quellen, Sicherheitsinformationen - Arzneimittel und Medizinprodukte

Current Drug Shortages

New/Updated Drug Shortages: AsmanexTwisthaler, Isoniazid Tablets, Ketorolac Injection, Methylphenidate HCl, Nalbuphine HCl Injection, Odansetron Injection 2 mg/mL, Potassium Chloride Injection 2 mEq/mL, Thiotepa for Injection, Ticlopidine Tablets 5/16/2012

Kategorien: Sicherheitsinformationen - Arzneimittel und Medizinprodukte

Drugs to be Discontinued

Drugs to be Discontinued: Digoxin Injection, Naltrexone Oral Tablets 5/16/2012

Kategorien: Quellen, Sicherheitsinformationen - Arzneimittel und Medizinprodukte

Generic Drugs: Information for Industry

News and Announcements updated

Kategorien: Quellen, Sicherheitsinformationen - Arzneimittel und Medizinprodukte

Medication Guides

Updated list of medication guides.

Kategorien: Quellen, Sicherheitsinformationen - Arzneimittel und Medizinprodukte

FDA Drug Safety Communication: Revised recommendations for cardiovascular monitoring and use of multiple sclerosis drug Gilenya (fingolimod)

The U.S. Food and Drug Administration (FDA) has completed its evaluation of a report of a patient who died after the first dose of multiple sclerosis drug Gilenya (fingolimod). The agency also has evaluated additional clinical trial and postmarket data for Gilenya, including reports of patients who died of cardiovascular events or unknown causes.

Kategorien: Quellen, Sicherheitsinformationen - Arzneimittel und Medizinprodukte

National Drug Code Directory

Kategorien: Quellen, Sicherheitsinformationen - Arzneimittel und Medizinprodukte

FDA Drug Safety Communication: Safety review of a reported death after the first dose of Multiple Sclerosis drug Gilenya (fingolimod)

[12-20-2011] The U.S. Food and Drug Administration (FDA) has received a report of a patient with multiple sclerosis (MS) who died within 24 hours of taking the first dose of Gilenya (fingolimod).

Kategorien: Quellen, Sicherheitsinformationen - Arzneimittel und Medizinprodukte

FDA Drug Safety Communication: Updated information about the risk of blood clots in women taking birth control pills containing drospirenone

The U.S. Food and Drug Administration (FDA) has completed its review of recent observational (epidemiologic) studies regarding the risk of blood clots in women taking drospirenone-containing birth control pills

Kategorien: Quellen, Sicherheitsinformationen - Arzneimittel und Medizinprodukte

FDA Drug Safety Communication: Updated information on drug interactions between Victrelis (boceprevir) and certain boosted HIV protease inhibitor drugs

The U.S. Food and Drug Administration (FDA) is notifying the public that co-administration of Victrelis (boceprevir), a hepatitis C virus (HCV) protease inhibitor, along with certain ritonavir-boosted human immunodeficiency virus (HIV) protease inhibitors, is not recommended at this time because of the possibility of reducing the effectiveness of the medicines, permitting the amount of HCV or HIV virus in the blood (viral load) to increase.

Kategorien: Quellen, Sicherheitsinformationen - Arzneimittel und Medizinprodukte

FDA Drug Safety Communication: Planned return of CardioGen-82 to market with new Boxed Warning

[2-15-2012] The U.S. Food and Drug Administration (FDA) is notifying healthcare professionals; in particular, the medical imaging community, about the planned return of CardioGen-82 to the U.S. market following the voluntary recall by the manufacturer, Bracco Diagnostics, Inc., on July 25, 2011.

Kategorien: Quellen, Sicherheitsinformationen - Arzneimittel und Medizinprodukte

FDA Drug Safety Communication: Safety review update of cancer drug Revlimid (lenalidomide) and risk of developing new types of malignancies

The U.S. Food and Drug Administration (FDA) is informing the public of an increased risk of second primary malignancies (new types of cancer) in patients with newly-diagnosed multiple myeloma who received Revlimid (lenalidomide).

Kategorien: Quellen, Sicherheitsinformationen - Arzneimittel und Medizinprodukte

FDA Drug Safety Communication: New risk factor for Progressive Multifocal Leukoencephalopathy (PML) associated with Tysabri (natalizumab)

[01-20-2012] The U.S. Food and Drug Administration (FDA) is informing the public that testing positive for anti-JC virus (JCV) antibodies has been identified as a risk factor for progressive multifocal leukoencephalopathy (PML).

Kategorien: Quellen, Sicherheitsinformationen - Arzneimittel und Medizinprodukte

BMIS Zip Download File

File updated through 3/27/2012.

Kategorien: Quellen, Sicherheitsinformationen - Arzneimittel und Medizinprodukte

FDA Drug Safety Communication: Update: Preliminary findings from ongoing investigations of CardioGen-82

[1-12-2012] The U.S. Food and Drug Administration (FDA) is updating healthcare professionals and the public about preliminary findings from ongoing investigations following the voluntary recall of CardioGen-82 on July 25, 2011 by the manufacturer, Bracco Diagnostics, Inc.

Kategorien: Quellen, Sicherheitsinformationen - Arzneimittel und Medizinprodukte

Pediatric Exclusivity Statistics

Updated list.

Kategorien: Quellen, Sicherheitsinformationen - Arzneimittel und Medizinprodukte

Written Requests Issued

Updated list of approved active moieties to which FDA has issued a Written Request for pediatric studies

Kategorien: Quellen, Sicherheitsinformationen - Arzneimittel und Medizinprodukte