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Food and Drug Administration--Press Releases



Press releases from FDA



Last Build Date: Tue, 28 Mar 2017 11:14:00 -0400

 



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).



Louisiana drug and dietary supplement maker ordered to cease operations due to federal violations

Tue, 21 Feb 2017 13:00:00 -0500

On Friday, U.S. District Judge Robert G. James for the U.S. District Court for the Western District of Louisiana entered a consent decree of permanent injunction against Pick and Pay Inc./Cili Minerals, a manufacturer and distributor of drugs and dietary supplements, and its owner, Anton S. Botha, requiring the business to immediately cease operations until it comes into compliance with federal laws.



FDA approves new psoriasis drug

Wed, 15 Feb 2017 17:47:00 -0500

The U.S. Food and Drug Administration today approved Siliq (brodalumab) to treat adults with moderate-to-severe plaque psoriasis. Siliq is administered as an injection.



FDA approves drug to treat Duchenne muscular dystrophy

Thu, 09 Feb 2017 14:05:00 -0500

The U.S. Food and Drug Administration today approved Emflaza (deflazacort) tablets and oral suspension to treat patients age 5 years and older with Duchenne muscular dystrophy (DMD), a rare genetic disorder that causes progressive muscle deterioration and weakness. Emflaza is a corticosteroid that works by decreasing inflammation and reducing the activity of the immune system.



Federal judge approves consent decree with California dietary supplement distributor, Regeneca Worldwide

Thu, 09 Feb 2017 10:47:00 -0500

A California dietary supplement distributor has been ordered by a federal court to stop selling its products, which were found to contain unsafe ingredients including 1, 3-dimethylamylamine (DMAA).



FDA permits marketing of first newborn screening system for detection of four, rare metabolic disorders

Fri, 03 Feb 2017 16:32:00 -0500

FDA permits marketing of first newborn screening system for detection of four, rare metabolic disorders