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Preview: Food and Drug Administration--Press Releases

Food and Drug Administration--Press Releases



Press releases from FDA



Last Build Date: Tue, 27 Jun 2017 09:57:00 -0400

 



FDA Tackles Drug Competition to Improve Patient Access

Tue, 27 Jun 2017 09:57:00 -0400

Today, the U.S. Food and Drug Administration is taking two new, important steps to increase competition in the market for prescription drugs and facilitate entry of lower-cost alternatives. The agency published a list of off-patent, off-exclusivity branded drugs without approved generics, and also implemented, for the first time, a new policy to expedite the review of generic drug applications where competition is limited.



Statement from FDA Commissioner Scott Gottlieb, M.D., on the importance of the Drug Quality and Security Act and overseeing the safety of compounded drugs

Mon, 26 Jun 2017 20:06:00 -0400

In late 2012, the United States faced the most serious outbreak associated with contaminated compounded drugs in recent history, involving hundreds of people, in many states, who developed fungal infections related to a compounded product. It was an incident that resulted in dozens of deaths.



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

Thu, 22 Jun 2017 17:15:00 -0400

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, 20 Jun 2017 13:24:00 -0400

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, 15 Jun 2017 13:49:00 -0400

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, 15 Jun 2017 12:33:00 -0400

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, 13 Jun 2017 09:03:00 -0400

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, 08 Jun 2017 16:15:00 -0400

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, 05 Jun 2017 15:44:00 -0400

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, 30 May 2017 16:49:00 -0400

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, 23 May 2017 15:01:00 -0400

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, 22 May 2017 10:50:00 -0400

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, 17 May 2017 16:14:00 -0400

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, 17 May 2017 08:51:00 -0400

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, 12 May 2017 12:51:00 -0400

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, 05 May 2017 16:59:00 -0400

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, 05 May 2017 14:48:00 -0400

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.