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Press releases from FDA
Updated: 14 min 57 sec ago

FDA Tackles Drug Competition to Improve Patient Access

Tue, 2017-06-27 08:57
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, 2017-06-26 19:06
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, 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.

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