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Press releases from FDA
Updated: 1 hour 44 min ago

FDA approves first subcutaneous C1 Esterase Inhibitor to treat rare genetic disease

Thu, 2017-06-22 16:15
The U.S. Food and Drug Administration today approved Haegarda, the first C1 Esterase Inhibitor (Human) for subcutaneous (under the skin) administration to prevent Hereditary Angioedema (HAE) attacks in adolescent and adult patients. The subcutaneous route of administration allows for easier at-home self-injection by the patient or caregiver, once proper training is received.

U.S. Marshals seize adulterated food from a Minnesota warehouse

Tue, 2017-06-20 12:24
The U.S. Food and Drug Administration announced that on June 15, the U.S. Marshals Service seized food products held at Professional Warehouse and Distribution, Inc., in St. Paul, Minnesota. The food products seized are worth approximately $73,000 and include, among other things, barley flour, spices, pasta, dried beans, tea and cookies.

Statement from FDA Commissioner Scott Gottlieb, M.D., on the 2016 National Youth Tobacco Survey results

Thu, 2017-06-15 12:49
While the latest numbers from the 2016 National Youth Tobacco Survey are encouraging, it is critical that we work to ensure this downward trend continues over the long term across all tobacco products. Every day in the U.S., more than 2,500 youth under the age of 18 smoke their first cigarette and more than 400 youth become daily cigarette smokers. It is also clear from these most recent numbers that youth are continuing to experiment with, or becoming regular users of, a wide range of other tobacco products.

Sonar Products ordered to cease operations, Stratus Pharmaceuticals ordered to cease distributing unapproved drugs

Thu, 2017-06-15 11:33
Today, U.S. District Judge Kathleen M. Williams for the Southern District of Florida entered a consent decree of permanent injunction between the United States and Stratus Pharmaceuticals Inc. of Miami, Florida, Sonar Products Inc. of Carlstadt, New Jersey and two of the companies’ officers, Alberto Hoyo and Juan Carlos Billoch.

Statement from FDA Commissioner Scott Gottlieb, M.D. – FDA is taking new steps to help assess opioid drugs with abuse-deterrent properties

Tue, 2017-06-13 08:03
Last month, I asked my colleagues at the FDA to identify what additional and more forceful steps the FDA can take, on top of the vigorous work the agency is already doing, to address the crisis of opioid addiction. Everyone at the FDA is committed to focusing on all aspects of the epidemic. The new policy steps that we announced included the formation of a steering committee to examine additional regulatory and policy actions that we can take to combat this crisis. This steering committee will place particular emphasis on evaluating efforts we can take to reduce the number of new cases of addiction.

FDA requests removal of Opana ER for risks related to abuse

Thu, 2017-06-08 15:15
Today, the U.S. Food and Drug Administration requested that Endo Pharmaceuticals remove its opioid pain medication, reformulated Opana ER (oxymorphone hydrochloride), from the market. After careful consideration, the agency is seeking removal based on its concern that the benefits of the drug may no longer outweigh its risks. This is the first time the agency has taken steps to remove a currently marketed opioid pain medication from sale due to the public health consequences of abuse.

FDA expands use of Sapien 3 artificial heart valve for high-risk patients

Mon, 2017-06-05 14:44
The U.S. Food and Drug Administration today approved an expanded indication for the Sapien 3 Transcatheter Heart Valve (THV) for patients with symptomatic heart disease due to failure of a previously placed bioprosthetic aortic or mitral valve whose risk of death or severe complications from repeat surgery is high or greater.

FDA approves first generic Strattera for the treatment of ADHD

Tue, 2017-05-30 15:49
The U.S. Food and Drug Administration today approved the first generic versions of Strattera (atomoxetine) to treat attention-deficit/hyperactivity disorder (ADHD) in pediatric and adult patients.

FDA approves first cancer treatment for any solid tumor with a specific genetic feature

Tue, 2017-05-23 14:01
The U.S. Food and Drug Administration today granted accelerated approval to a treatment for patients whose cancers have a specific genetic feature (biomarker). This is the first time the agency has approved a cancer treatment based on a common biomarker rather than the location in the body where the tumor originated

FDA approves first drug to specifically treat giant cell arteritis

Mon, 2017-05-22 09:50
The U.S. Food and Drug Administration today expanded the approved use of subcutaneous Actemra (tocilizumab) to treat adults with giant cell arteritis. This new indication provides the first FDA-approved therapy, specific to this type of vasculitis.

FDA expands approved use of Kalydeco to treat additional mutations of cystic fibrosis

Wed, 2017-05-17 15:14
The U.S. Food and Drug Administration today expanded the approved use of Kalydeco (ivacaftor) for treating cystic fibrosis. The approval triples the number of rare gene mutations that the drug can now treat, expanding the indication from the treatment of 10 mutations, to 33. The agency based its decision, in part, on the results of laboratory testing, which it used in conjunction with evidence from earlier human clinical trials. The approach provides a pathway for adding additional, rare mutations of the disease, based on laboratory data.

FDA warns Americans about risk of inaccurate results from certain lead tests

Wed, 2017-05-17 07:51
The U.S. Food and Drug Administration and Centers for Disease Control and Prevention are warning Americans that certain lead tests manufactured by Magellan Diagnostics may provide inaccurate results for some children and adults in the United States.

FDA authorizes use of new device to treat esophageal birth defect in babies

Fri, 2017-05-12 11:51
The U.S. Food and Drug Administration today authorized use of the Flourish Pediatric Esophageal Atresia Anastomosis, a first-of-its-kind medical device to treat infants up to one year old for a birth defect that causes a gap in their esophagus, called esophageal atresia.

FDA approves drug to treat ALS

Fri, 2017-05-05 15:59
The U.S. Food and Drug Administration today approved Radicava (edaravone) to treat patients with amyotrophic lateral sclerosis (ALS), commonly referred to as Lou Gehrig’s disease.

FDA takes action against Florida medicated animal feed manufacturer

Fri, 2017-05-05 13:48
On May 4, 2017, the United States District Court for the Southern District of Florida entered a consent decree of permanent injunction between the United States and Syfrett Feed Company Inc. of Okeechobee, Florida; its owner and President Charles B. Syfrett I; Vice President Melissa S. Montes De Oca; and Operations Manager Charles B. Syfrett II. The consent decree requires the company to adequately control its production of medicated animal feeds and to comply with federal law before it can resume its medicated feed operations.

FDA approves new combination treatment for acute myeloid leukemia

Fri, 2017-04-28 09:20
The U.S. Food and Drug Administration today approved Rydapt (midostaurin) for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who have a specific genetic mutation called FLT3, in combination with chemotherapy. The drug is approved for use with a companion diagnostic, the LeukoStrat CDx FLT3 Mutation Assay, which is used to detect the FLT3 mutation in patients with AML.

FDA approves first treatment for a form of Batten disease

Thu, 2017-04-27 12:02
The U.S. Food and Drug Administration today approved Brineura (cerliponase alfa) as a treatment for a specific form of Batten disease. Brineura is the first FDA-approved treatment to slow loss of walking ability (ambulation) in symptomatic pediatric patients 3 years of age and older with late infantile neuronal ceroid lipofuscinosis type 2 (CLN2), also known as tripeptidyl peptidase-1 (TPP1) deficiency.

FDA expands approved use of Stivarga to treat liver cancer

Thu, 2017-04-27 11:45
The U.S. Food and Drug Administration today expanded the approved use of Stivarga (regorafinib) to include treatment of patients with hepatocellular carcinoma (HCC or liver cancer) who have been previously treated with the drug sorafenib. This is the first FDA-approved treatment for a liver cancer in almost a decade.

FDA takes action against 14 companies for selling illegal cancer treatments

Tue, 2017-04-25 09:07
The U.S. Food and Drug Administration today posted warning letters addressed to 14 U.S.-based companies illegally selling more than 65 products that fraudulently claim to prevent, diagnose, treat or cure cancer. The products are marketed and sold without FDA approval, most commonly on websites and social media platforms.

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, 2017-04-20 10:42
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).

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