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Preview: Food and Drug Administration--Press Releases

Food and Drug Administration--Press Releases



Press releases from FDA



Last Build Date: Thu, 20 Apr 2017 11:42:00 -0400

 



FDA statement from Douglas Throckmorton, M.D., deputy center director for regulatory programs, Center for Drug Evaluation and Research, on new warnings about the use of codeine and tramadol in children & nursing mothers

Thu, 20 Apr 2017 11:42:00 -0400

The health and safety of children is a top priority at the FDA, which is why today we are requiring a series of changes to the labeling of two types of opioid medications in order to help better protect children from serious risks associated with these medicines – codeine (found in some prescription pain and cough medicines and some over-the-counter cough medicines) and tramadol (found in some prescription pain medicines).



FDA allows marketing of first whole slide imaging system for digital pathology

Wed, 12 Apr 2017 16:56:00 -0400

The U.S. Food and Drug Administration today permitted marketing of the Philips IntelliSite Pathology Solution (PIPS), the first whole slide imaging (WSI) system that allows for review and interpretation of digital surgical pathology slides prepared from biopsied tissue. This is the first time the FDA has permitted the marketing of a WSI system for these purposes.



FDA approves first drug to treat tardive dyskinesia

Tue, 11 Apr 2017 17:35:00 -0400

The U.S. Food and Drug Administration today approved Ingrezza (valbenazine) capsules to treat adults with tardive dyskinesia. This is the first drug approved by the FDA for this condition.



FDA approves two hepatitis C drugs for pediatric patients

Fri, 07 Apr 2017 10:27:00 -0400

The U.S. Food and Drug Administration today approved supplemental applications for Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) to treat hepatitis C virus (HCV) in children ages 12 to 17. Harvoni and Sovaldi were previously approved to treat HCV in adults.



FDA allows marketing of first direct-to-consumer tests that provide genetic risk information for certain conditions

Thu, 06 Apr 2017 11:18:00 -0400

The U.S. Food and Drug Administration today allowed marketing of 23andMe Personal Genome Service Genetic Health Risk (GHR) tests for 10 diseases or conditions. These are the first direct-to-consumer (DTC) tests authorized by the FDA that provide information on an individual’s genetic predisposition to certain medical diseases or conditions, which may help to make decisions about lifestyle choices or to inform discussions with a health care professional.



FDA alerts consumers of nationwide voluntary recall of EpiPen and EpiPen Jr

Fri, 31 Mar 2017 18:34:00 -0400

The U.S. Food and Drug Administration is alerting consumers to Meridian Medical Technologies’ voluntary recall of 13 lots of Mylan’s EpiPen and EpiPen Jr (epinephrine injection) Auto-Injector products used for emergency treatment of severe allergic reactions. This recall is due to the potential that these devices may contain a defective part that may result in the devices’ failure to activate. The recalled product was manufactured by Meridian Medical Technologies and distributed by Mylan Specialty.



FDA approves new drug to treat multiple sclerosis

Wed, 29 Mar 2017 08:44:00 -0400

On March 28, the U.S. Food and Drug Administration approved Ocrevus (ocrelizumab) to treat adult patients with relapsing forms of multiple sclerosis (MS) and primary progressive multiple sclerosis (PPMS). This is the first drug approved by the FDA for PPMS. Ocrevus is an intravenous infusion given by a health care professional.



FDA approves new eczema drug Dupixent

Tue, 28 Mar 2017 11:14:00 -0400

The U.S. Food and Drug Administration today approved Dupixent (dupilumab) injection to treat adults with moderate-to-severe eczema (atopic dermatitis). Dupixent is intended for patients whose eczema is not controlled adequately by topical therapies, or those for whom topical therapies are not advisable. Dupixent can be used with or without topical corticosteroids.



FDA approves maintenance treatment for recurrent epithelial ovarian, fallopian tube or primary peritoneal cancers

Mon, 27 Mar 2017 16:04:00 -0400

The U.S. Food and Drug Administration today approved Zejula (niraparib) for the maintenance treatment (intended to delay cancer growth) of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, whose tumors have completely or partially shrunk (complete or partial response, respectively) in response to platinum-based chemotherapy.



FDA approves first treatment for rare form of skin cancer

Thu, 23 Mar 2017 14:25:00 -0400

The U.S. Food and Drug Administration today granted accelerated approval to Bavencio (avelumab) for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC), including those who have not received prior chemotherapy. This is the first FDA-approved treatment for metastatic MCC, a rare, aggressive form of skin cancer.



FDA approves drug to treat Parkinson’s disease

Tue, 21 Mar 2017 15:20:00 -0400

The U.S. Food and Drug Administration today approved Xadago (safinamide) tablets as an add-on treatment for patients with Parkinson’s disease who are currently taking levodopa/carbidopa and experiencing “off” episodes. An “off” episode is a time when a patient’s medications are not working well, causing an increase in Parkinson’s symptoms, such as tremor and difficulty walking.



Colorado unapproved drug and dietary supplement makers ordered to cease operations for federal violations

Tue, 14 Mar 2017 13:08:00 -0400

Yesterday, U.S. District Judge Marcia S. Krieger for the U.S. District Court for Colorado entered a consent decree of permanent injunction against EonNutra LLC, CDSM LLC and HABW LLC, manufacturers and distributors of unapproved drugs and dietary supplements, and their owner, Michael Floren, requiring Floren’s businesses to immediately cease operations until they come into compliance with federal laws.



FDA approves first treatment for frequent urination at night due to overproduction of urine

Fri, 03 Mar 2017 15:06:00 -0500

The U.S. Food and Drug Administration today approved Noctiva (desmopressin acetate) nasal spray for adults who awaken at least two times per night to urinate due to a condition known as nocturnal polyuria (overproduction of urine during the night). Noctiva is the first FDA-approved treatment for this condition.



Mutual Recognition promises new framework for pharmaceutical inspections for United States and European Union

Thu, 02 Mar 2017 07:57:00 -0500

The United States and the European Union (EU) completed an exchange of letters to amend the Pharmaceutical Annex to the 1998 U.S.-EU Mutual Recognition Agreement. Under this agreement, U.S. and EU regulators will be able to utilize each other’s good manufacturing practice inspections of pharmaceutical manufacturing facilities.



FDA approves Odactra for house dust mite allergies

Wed, 01 Mar 2017 16:57:00 -0500

The U.S. Food and Drug Administration today approved Odactra, the first allergen extract to be administered under the tongue (sublingually) to treat house dust mite (HDM)-induced nasal inflammation (allergic rhinitis), with or without eye inflammation (conjunctivitis), in people 18 through 65 years of age.



FDA approves Xermelo for carcinoid syndrome diarrhea

Tue, 28 Feb 2017 16:30:00 -0500

The U.S. Food and Drug Administration today approved Xermelo (telotristat ethyl) tablets in combination with somatostatin analog (SSA) therapy for the treatment of adults with carcinoid syndrome diarrhea that SSA therapy alone has inadequately controlled.



FDA clears test to help manage antibiotic treatment for lower respiratory tract infections and sepsis

Thu, 23 Feb 2017 17:30:00 -0500

The U.S. Food and Drug Administration today cleared the expanded use of the Vidas Brahms PCT Assay to help health care providers determine if antibiotic treatment should be started or stopped in patients with lower respiratory tract infections, such as community-acquired pneumonia, and stopped in patients with sepsis. This is the first test to use procalcitonin (PCT), a protein associated with the body’s response to a bacterial infection, as a biomarker to help make antibiotic management decisions in patients with these conditions.



FDA allows marketing of test to identify organisms that cause bloodstream infections and provide antibiotic sensitivity results

Thu, 23 Feb 2017 16:55:00 -0500

The U.S. Food and Drug Administration today allowed marketing of the PhenoTest BC Kit, performed on the Pheno System. This is the first test to identify organisms that cause bloodstream infections and provide information about which antibiotics the organism is likely to respond to (antibiotic sensitivity).