Food and Drug Administration News

Date Posted
Article Title
12/21/2012
Inconsistency Seen in Safety Labeling for Generic Drugs

Although warnings are supposed to match brand-name equivalents, researchers found many variations

12/21/2012
FDA Panel Recommends Against 1st Drug for Chronic Fatigue Syndrome

Safety was a concern, and only some patients got relief from the treatment

12/20/2012
FDA, States Weigh Pharmacy Regulation in Wake of Meningitis Outbreak

States ask agency to play a greater role in policing specialty pharmacies, protecting patients

12/20/2012
FDA Panel Considers 1st Drug for Chronic Fatigue Syndrome

Only some patients got relief from the experimental treatment, experts say

12/17/2012
Signifor Approved for Cushing's Disease

In cases that cannot be treated through surgery

12/14/2012
Raxibacumab Approved for Inhalational Anthrax

Neutralizes anthrax toxins, which can kill

12/14/2012
Iclusig Approved for Rare Leukemias

Blocks proteins that spur cancer development

12/13/2012
Stop-Smoking Drug Chantix May Carry Heart Risks, FDA Warns

Smokers should talk with their doctor before taking the drug, agency says

12/13/2012
Marijuana Extract May Not Relieve MS Spasms: Review

Sativex mouth spray that contains the extract does not seem effective, research shows

12/10/2012
Zytiga's Use Expanded for Advanced Prostate Cancer

Decreases body's production of testosterone

12/10/2012
FDA OKs Expanded Use of Prostate Cancer Drug

Zytiga shows benefits for treating late-stage disease, agency says

12/6/2012
FDA Issues Warning for Nature's Deli Chicken Jerky Dog Treats

One lot may be infected with salmonella, health officials say

12/5/2012
FDA Pulls One Generic Form of Wellbutrin Off the Market

Research found extended-release Budeprion at 300 mg dose was not equivalent to brand-name version of antidepressant

12/4/2012
'Synthetic Pot' Sending Thousands of Young People to ER: Report

Users don't know what chemical mix they're getting or which complications can arise, experts warn

12/3/2012
Despite FDA Warning, Sports Supplements Still Available Online: Study

Safety issues remain for 16 cited products, researcher says

12/3/2012
FDA to Collaborate on Development of Medical Devices

New public-private partnership should speed approval process, agency says

11/29/2012
Cometriq Approved for Rare Thyroid Cancer

Drug designed to inhibit tumor growth

11/21/2012
Sleep Positioners Linked to Infant Suffocation: CDC

These devices endanger babies' lives and should not be used, U.S. agencies warn

11/21/2012
11/20/2012
11/20/2012
Meningitis/Steroid Toll Now 34 Dead

490 people have been sickened, CDC says

11/20/2012
Supplement Use Widespread Among Americans

But perception rather than solid evidence appears to drive demand, researchers say

11/16/2012
Meningitis Outbreak Toll Now 33 Dead, 480 Sickened, CDC Says

Lawmakers, pharmacy representatives wrangled this week in Congressional hearings

11/15/2012
Compounding Pharmacists Oppose Greater U.S. Oversight

Existing rules, basically on state level, are enough, lobbyist says; death toll tied to tainted steroids still at 32

11/15/2012
Drug-Eluting Stent Approved for Peripheral Arterial Disease

Coated hollow tube props open thigh artery

11/14/2012
Owner of Meningitis-Linked Pharmacy Declines to Testify Before Congress

FDA commissioner asks for more authority over specialty pharmacies like one linked to tainted injections

11/13/2012
Congress to Open Hearings Into Steroid/Meningitis Outbreak

32 deaths, 438 illnesses linked to contaminated drug, CDC says

11/13/2012
'Micro-Stents' May Hold Potential to Treat Glaucoma

Devices appear to reduce pressure in the eye, studies find

11/12/2012
Steroid Shots for Sciatica: Benefits Only Brief, Analysis Finds

Patients should discuss risks with their doctor, researcher says

11/9/2012
Steroid-Meningitis Toll Now 32 Dead, 438 Sickened, CDC Says

Infections still limited to 19 states, with Michigan and Tennessee hit hardest

11/8/2012
Steroid-Meningitis Toll Now 31 Dead, 424 Sickened, CDC Says

Infections reported in 19 states; Michigan and Tennessee hit hardest

11/7/2012
Report Details Start of Steroid Meningitis Outbreak

More federal oversight needed to prevent repeat occurrences, expert says

11/7/2012
Xeljanz Approved for Rheumatoid Arthritis

For people who can't take methotrexate

11/5/2012
Steroid-Meningitis Toll Now 30 Dead, 419 Sickened, CDC Says

Infections reported in 19 states; Michigan and Tennessee hit hardest

11/5/2012
Xarelto's Approval Expanded

To include people with deep vein thrombosis or pulmonary embolism

11/2/2012
FDA: More Tainted Products at Firm Tied to Meningitis Outbreak

Toll on Friday stood at 29 people dead, 404 sickened, officials report

11/1/2012
Bacteria Found in Other Products From Firm Tied to Meningitis Outbreak: FDA

Massachusetts also tightens regulation of specialty pharmacies like New England Compounding Center

10/31/2012
Company With Ties to Meningitis-Linked Pharmacy Recalls All Products

FDA finds worrisome conditions at Ameridose plant, which has same owners as New England Compounding Center

10/30/2012
Fungal Meningitis Outbreak Toll Now 28 Dead, 363 Sickened

Cases rise as investigation into compounding pharmacies implicated in the outbreak continues

10/29/2012
Second Compounding Pharmacy Shut Down in Massachusetts

As meningitis outbreak reaches 354 cases, state inspectors cite 'significant' problems at Infusion Resource facility

10/27/2012
'Greenish-Black' Contaminant in Vials of Steroid Behind Meningitis Outbreak: FDA

Officials say 25 are now dead, 338 sickened from tainted injections

10/26/2012
'Greenish-Black' Contaminant in Vials of Steroid Behind Meningitis Outbreak: FDA

Officials say 25 are now dead, 338 sickened from tainted injections

10/26/2012
Synribo Approved to Treat Rare Leukemia

If other treatments haven't stopped CML's progression

10/25/2012
Cases Linked to Fungal Meningitis Now Number 328

People in 18 states sickened; death toll remains at 24, CDC says

10/24/2012
Mass. Launches Criminal Probe of Firm Linked to Meningitis Outbreak: Report

Toll now stands at 24 dead, 317 sickened in 17 states, CDC says

10/23/2012
Mass. Launches Criminal Probe of Firm Linked to Meningitis Outbreak: Report

Count now stands at 23 dead, 308 sickened in 17 states, CDC says

10/23/2012
Doctors Warn About High Levels of Caffeine in Some Energy Drinks

Concerns follow reports that Monster beverages may have been linked to five deaths in recent years

10/23/2012
'Off-Label' Use of Meds Routine in Pediatric ICU

But not enough is known about their safety and effectiveness in children, researcher says

10/23/2012
Records Show Problems at Steroid Pharmacy as Far Back as '06

Meningitis outbreak count now stands at 23 dead, 308 sickened: CDC

10/22/2012
Fycompa Approved for Epileptic Seizures

Among people aged 12 and older