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Recent news from the US Food and Drug Administration.
Click title to see the full article at the FDA
website. For the most up-to-date headlines, check out the FDA
Newsroom. Press announcements from 2004 to 2009 are available through
the FDA
Archive.
FDA
Recalls: FDA posts press releases and other notices of recalls and
market withdrawals from the firms involved as a service to consumers,
the media, and other interested parties. FDA does not endorse either the
product or the company. This site does not contain a complete list of
recalls -
search for recalls at the official FDA site.
| English |
| December 22, 2015 - FDA
approves Zurampic to treat high blood uric acid levels associated
with gout |
| December 22, 2015 - FDA
approves new orphan drug to treat pulmonary arterial hypertension |
| December 21, 2015 - FDA
updates blood donor deferral policy to reflect the most current scientific
evidence and continue to ensure the safety of the U.S. blood supply |
| December 18, 2015 - FDA
permits marketing of fecal continence restoration system |
| December 18, 2015 - FDA
proposes tanning bed age restrictions and other important safety measures |
| December 17, 2015 - FDA
approves wearable defibrillator for children at risk for sudden cardiac
arrest |
| December 16, 2015 - FDA
approves Basaglar, the first “follow-on” insulin glargine
product to treat diabetes |
| December 15, 2015 - FDA
approves Bridion to reverse effects of neuromuscular blocking drugs
used during surgery |
| December 15, 2015 - FDA
takes action against Vermont dairy farm for illegally administering
drugs to cattle |
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December 11, 2015 - FDA
approves new oral therapy to treat ALK-positive lung cancer
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| December 11, 2015 - FDA
approves first emergency treatment for overdose of certain types of
chemotherapy |
| December 08, 2015 - FDA
allows marketing of cooling cap to reduce hair loss during chemotherapy |
| December 08, 2015 - FDA
approves first recombinant von Willebrand factor to treat bleeding
episodes |
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December 08, 2015 - FDA
approves first drug to treat a rare enzyme disorder in pediatric
and adult patients
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December 07, 2015 - FDA
clears military traumatic wound dressing for use in the civilian
population
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| English |
| November 30, 2015 - FDA
approves Empliciti, a new immune-stimulating therapy to treat multiple
myeloma |
| November 24, 2015 - FDA
approves first seasonal influenza vaccine containing an adjuvant |
| November 24, 2015 - FDA
approves Portrazza to treat advanced squamous non-small cell lung
cancer |
| November 23, 2015 - FDA
approves vaccine for use after known or suspected anthrax exposure |
| November 23, 2015 - FDA
approves Opdivo to treat advanced form of kidney cancer |
| November 20, 2015 - FDA
approves Ninlaro, new oral medication to treat multiple myeloma |
| November 19, 2015 - FDA
takes several actions involving genetically engineered plants and
animals for food |
| November 18, 2015 - FDA
moves quickly to approve easy-to-use nasal spray to treat opioid overdose |
| November 17, 2015 - FDA
takes action to protect consumers from potentially dangerous dietary
supplements |
| November 16, 2015 - FDA
approves Darzalex for patients with previously treated multiple myeloma |
| November 13, 2015 - FDA
approves modified antihemophilic factor for hemophilia A |
| November 13, 2015 - FDA
orders recall under consent decree for all Custom Ultrasonics automated
endoscope reprocessors |
| November 13, 2015 - FDA
approves new pill to treat certain patients with non-small cell lung
cancer |
| November 13, 2015 - FDA
releases groundbreaking food safety rules for produce farms and imported
food to modernize and strengthen food safety system |
| November 10, 2015 - FDA
issues first product marketing orders through premarket tobacco application
pathway |
| November 10, 2015 - FDA
approves Cotellic as part of combination treatment for advanced melanoma |
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November 05, 2015 - FDA
approves new treatment for HIV
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November 04, 2015 -
FDA
approves Nucala to treat severe asthma
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| English |
| October 30, 2015 - FDA
orders juice manufacturer to cease operations |
| October 29, 2015 - FDA
takes enforcement action against retailers who have repeatedly sold
tobacco products to minors |
| October 28, 2015 - FDA
approves Yervoy to reduce the risk of melanoma returning after surgery |
| October 27, 2015 - FDA
approves first-of-its-kind product for the treatment of melanoma |
| October 23, 2015 - FDA
approves new treatment for rare metabolic disorder |
| October 23, 2015 - FDA
approves new therapy for certain types of advanced soft tissue sarcoma |
| October 22, 2015 - FDA
approves new treatment for advanced pancreatic cancer |
| October 21, 2015 - FDA
approves new drug to treat hyperkalemia |
| October 21, 2015 - US
Marshals seize adulterated crab products for food safety violations |
| October 20, 2015 - FDA
approves first Factor X concentrate to treat patients with rare hereditary
bleeding disorder |
| October 16, 2015 - FDA
approves Praxbind, the first reversal agent for the anticoagulant
Pradaxa |
| October 09, 2015 - FDA
expands approved use of Opdivo in advanced lung cancer |
| October 08, 2015 - FDA
allows marketing of the first nucleic acid-based test to detect multiple
pathogens from a single sample of cerebrospinal fluid |
| October 07, 2015 - Federal
judge issues permanent injunction against South Dakota laser manufacturer |
| October 06, 2015 - FDA
launches national public education campaign to prevent and reduce
tobacco use among multicultural youth |
| October 06, 2015 - FDA
approves new injectable drug to treat schizophrenia |
| October 05, 2015 - FDA
approves expanded indication for medical device to treat a form of
brain cancer |
| October 05, 2015 - FDA
orders duodenoscope manufacturers to conduct postmarket surveillance
studies in health care facilities |
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October 02, 2015 - FDA
approves Keytruda for advanced non-small cell lung cancer
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| English |
| September 29, 2015 - FDA
permits marketing of new laser-based hearing aid with potential for
broad sound amplification |
| September 28, 2015 - Federal
judge enters permanent injunction against Florida dietary supplements
maker, Sunset Natural Products Inc. |
| September 25, 2015 - FDA
approves two new drug treatments for diabetes mellitus |
| September 22, 2015 - FDA
approves new oral medication to treat patients with advanced colorectal
cancer |
| September 21, 2015 - FDA
awards 18 grants to stimulate product development for rare diseases |
| September 17, 2015 - FDA
approves new drug to treat schizophrenia and bipolar disorder |
| September 15, 2015 - FDA
issues orders that will stop further U.S. sale and distribution of
four R.J. Reynolds Tobacco Company cigarette products |
| September 10, 2015 - The
FDA takes important steps in modernizing the food safety system |
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September 04, 2015 - FDA
approves new orphan drug to treat rare autosomal recessive disorder
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September 02, 2015 - FDA
approves new drug treatment for nausea and vomiting from chemotherapy
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| English |
| July 28, 2015 - FDA
approves non-surgical temporary balloon device to treat obesity |
| July 24, 2015 - FDA
approves new treatment for chronic hepatitis C genotype 3 infections |
| July 24, 2015 - FDA
approves Praluent to treat certain patients with high cholesterol |
| July 24, 2015 - FDA
approves new treatment for most common form of advanced skin cancer |
| July 24, 2015 - FDA
approves Technivie for treatment of chronic hepatitis C genotype 4 |
| July 24, 2015 - FDA
revises proposed Nutrition Facts label rule to include a daily value
for added sugars |
| July 23, 2015 - FDA
approves diagnostic test to differentiate between types of HIV infection |
| July 22, 2015 - FDA
Food Safety Challenge winners develop innovative technologies to detect
Salmonella |
| July 16, 2015 - FDA
authorizes use of prosthesis for rehabilitation of above-the-knee
amputations |
| July 13, 2015 - FDA
approves targeted therapy for first-line treatment of patients with
a type of metastatic lung cancer |
| July 13, 2015 - FDA
approves new drug to treat schizophrenia and as an add on to an antidepressant
to treat major depressive disorder |
| July 10, 2015 - FDA
takes steps to prevent sales of unapproved kidney drugs for dogs and
cats |
| July 07, 2015 - FDA
approves new drug to treat heart failure |
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July 02, 2015 - FDA
approves new treatment for cystic fibrosis
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| July 01, 2015 - Federal
judge enters permanent injunction against Acino Products, LLC |
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July 01, 2015 - FDA
takes action against unapproved prescription ear drop products
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| English |
| July 24, 2015 - FDA
approves new treatment for chronic hepatitis C genotype 3 infections |
| July 24, 2015 - FDA
approves Praluent to treat certain patients with high cholesterol |
| July 24, 2015 - FDA
approves new treatment for most common form of advanced skin cancer |
| July 24, 2015 - FDA
approves Technivie for treatment of chronic hepatitis C genotype 4 |
| July 24, 2015 - FDA
revises proposed Nutrition Facts label rule to include a daily value
for added sugars |
| July 23, 2015 - FDA
approves diagnostic test to differentiate between types of HIV infection |
| July 22, 2015 - FDA
Food Safety Challenge winners develop innovative technologies to detect
Salmonella |
| July 16, 2015 - FDA
authorizes use of prosthesis for rehabilitation of above-the-knee
amputations |
| July 13, 2015 - FDA
approves targeted therapy for first-line treatment of patients with
a type of metastatic lung cancer |
| July 13, 2015 - FDA
approves new drug to treat schizophrenia and as an add on to an antidepressant
to treat major depressive disorder |
| July 10, 2015 - FDA
takes steps to prevent sales of unapproved kidney drugs for dogs and
cats |
| July 07, 2015 - FDA
approves new drug to treat heart failure |
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July 02, 2015 - FDA
approves new treatment for cystic fibrosis
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| July 01, 2015 - Federal
judge enters permanent injunction against Acino Products, LLC |
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July 01, 2015 - FDA
takes action against unapproved prescription ear drop products
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| English |
| April 30, 2015 - FDA
approves Raplixa to help control bleeding during surgery |
| April 30, 2015 - FDA
issues proposed rule to address data gaps for certain active ingredients
in health care antiseptics |
| April 29, 2015 - FDA
approves treatment for fat below the chin |
| April 28, 2015 - FDA
approves first generic Abilify to treat mental illnesses |
| April 27, 2015 - FDA
enters consent decree with Medtronic, Inc. |
| April 23, 2015 - Illinois
food company agrees to stop production of contaminated sprouts |
| April 17, 2015 -
FDA approves first-of-its-kind corneal implant to improve near vision
in certain patients |
| April 16, 2015 - FDA
approves first generic Copaxone to treat multiple sclerosis |
| April 16, 2015 - U.S.
Marshals seize unapproved drugs from Florida distributor |
| April 15, 2015 -
FDA approves Corlanor to treat heart failure |
| April 13, 2015 - FDA
warns consumers not to use muscle growth product called Tri-Methyl
Xtreme |
| April 06, 2015 - FDA
approves breath test to aid in diagnosis of delayed gastric emptying |
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April 03, 2015 - Massachusetts
dairy operation agrees to permanent injunction to prevent illegal
drug residues in animals sold for food
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| April 02, 2015 - FDA
alerts health care professionals and patients not to use products
from the Prescription Center pharmacy in Fayetteville, N.C. |
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April 01, 2015 - FDA
issues final guidance on the evaluation and labeling of abuse-deterrent
opioids
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| English |
| March 30, 2015 - FDA
expands use of CoreValve System for aortic “valve-in-valve”
replacement |
| March 30, 2015 - California
seafood company to cease production of adulterated fish |
| March 25, 2015 - FDA
approves new treatment for diabetic retinopathy in patients with diabetic
macular edema |
| March 25, 2015 - FDA
approves treatment for inhalation anthrax |
| March 23, 2015 - FDA
approves blood pump system to help patients maintain stable heart
function during certain high-risk cardiac procedures |
| March 20, 2015 - FDA
concludes Arctic Apples and Innate Potatoes are safe for consumption |
| March 17, 2015 - FDA
approves Cholbam to treat rare bile acid synthesis disorders |
| March 12, 2015 - FDA
releases final guidance on reprocessing of reusable medical devices |
| March 11, 2015 - Federal
judge enters consent decree against Specialty Compounding LLC |
| March 10, 2015 - FDA
approves first therapy for high-risk neuroblastoma |
| March 09, 2015 - FDA
approves CPR devices that may increase chance of surviving cardiac
arrest |
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March 06, 2015 - FDA
approves new antifungal drug Cresemba
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| March 06, 2015 - FDA
authorizes use of first device to treat patients with dialysis-related
amyloidosis |
| March 06, 2015 - FDA
approves first biosimilar product Zarxio |
| March 04, 2015 - FDA
expands approved use of Opdivo to treat lung cancer |
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March 04, 2015 - FDA
launches drug shortages mobile app
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| English |
| February 25, 2015 - FDA
approves new antibacterial drug Avycaz |
| February 23, 2015 - FDA
approves Farydak for treatment of multiple myeloma |
| February 20, 2015 - FDA
approves closure system to permanently treat varicose veins |
| February 19, 2015 - FDA
permits marketing of first direct-to-consumer genetic carrier test
for Bloom syndrome |
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February 13, 2015 - FDA
issues new draft documents related to compounding of human drugs
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February 13, 2015 - FDA
approves Lenvima for a type of thyroid cancer
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February 12, 2015 - California
food company to cease operations for repeated food safety violations
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February 12, 2015 - FDA
permits marketing of fecal incontinence device for women
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February 12, 2015 - New
data shows test can help physicians remove patients with suspected
TB from isolation earlier
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February 09, 2015 - FDA
clears system to reduce stroke risk during stent and angioplasty
procedures
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February 06, 2015 - FDA
approves Lucentis to treat diabetic retinopathy in patients with
diabetic macular edema
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February 04, 2015 - Federal
judge approves consent decree with Maquet Holding B.V. & Co.
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February 04, 2015 - FDA
approves first tissue adhesive for internal use
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February 03, 2015 - FDA
approves Ibrance for postmenopausal women with advanced breast cancer
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February 02, 2015 - FDA
seeks $4.9 billion for FY 2016 to implement the FDA Food Safety
Modernization Act and improve the quality and safety of the medical
products Americans use
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| English |
| January 30, 2015 - FDA
expands uses of Vyvanse to treat binge-eating disorder |
| January 30, 2015 - United
States enters consent decree prohibiting illegal distribution of Luvena
Prebiotic products |
| January 29, 2015 - FDA
expands approved use of Imbruvica for rare form of non-Hodgkin lymphoma |
| January 28, 2015 - FDA
takes steps to improve reliability of automated external defibrillators |
| January 26, 2015 - FDA
approves first generic esomeprazole |
| January 26, 2015 - Dr.
Robert Califf named FDA Deputy Commissioner for Medical Products and
Tobacco |
| January 23, 2015 - FDA
permits marketing of first system of mobile medical apps for continuous
glucose monitoring |
| January 23, 2015 - FDA
approves a second vaccine to prevent serogroup B meningococcal disease |
| January 23, 2015 - FDA
approves Natpara to control low blood calcium levels in patients with
hypoparathyroidism |
| January 23, 2015 - Second
Turkish man sentenced for smuggling counterfeit cancer drugs |
| January 21, 2015 - FDA
approves new psoriasis drug Cosentyx |
| January 16, 2015 - Federal
judge approves consent decree with California dietary supplement maker |
| January 14, 2015 - FDA
approves first-of-kind device to treat obesity |
| January 08, 2015 - FDA
approves anti-clotting drug Savaysa |
| January 06, 2015 - FDA
grants first CLIA waiver for nucleic acid-based flu diagnostic test
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See the current
MedSun newsletter at the FDA website for Recalls and Safety Alerts,
Highlighted Reports, and Links to FDA/CDRH Databases and Other Information
Sources.
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