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category archive listing Category Archives: FDA Press Release

FDA Obtains Permanent Injunction Against Scientific Laboratories

Posted by H. Sandra Chevalier-Batik

FDA News

FOR IMMEDIATE RELEASE
May 16, 2008

Media Inquiries:
Rita Chappelle, 301-827-6242
Consumer Inquiries:
888-INFO-FDA

FDA Obtains Permanent Injunction Against Scientific Laboratories, Inc.
Company manufactures and distributes unapproved and adulterated drugs
The U.S. Food and Drug Administration (FDA) today announced that Scientific Laboratories Inc., and its president, Rajeshwari Patel, and [...]

Thromboembolic Events with Ortho Evra Contraceptive Patch

Posted by H. Sandra Chevalier-Batik

New Data on Thromboembolic Events with Ortho Evra Contraceptive Patch
The prescribing information for the Ortho Evra Contraceptive Transdermal Patch is being updated with results of a new study on the risk of venous thromboembolism. This study found that women aged 15-44 who used the birth control patch were at higher risk of developing venous thromboembolism [...]

Fentanyl (Duragesic) Patches Recalled

Posted by H. Sandra Chevalier-Batik

What are fentanyl skin patches?
FENTANYL (Duragesic®, E-TRANS® Fentanyl) relieves moderate to severe chronic pain. Fentanyl patches are commonly used to treat pain associated with cancer. Once the patch is applied, the medicine is slowly absorbed through your skin into the bloodstream to help control your pain. Generic fentanyl skin patches are available.
FDA Recalls and Safety [...]

Adverse Reactions Linked to Botox Use

Posted by H. Sandra Chevalier-Batik

FDA Notifies Public of Adverse Reactions Linked to Botox Use
Ongoing safety review of Botox, Botox Cosmetic and Myobloc taking place
The U.S. Food and Drug Administration today notified the public that Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B) have been linked in some cases to adverse reactions, including respiratory [...]

FDA Identifies First Steps in Requirements for Safety Plans

Posted by H. Sandra Chevalier-Batik

FDA News

FOR IMMEDIATE RELEASE
March 27, 2008

Media Inquiries:
Chris DiFrancesco, 301-827-6242
Consumer Inquiries:
888-INFO-FDA

FDA Identifies First Steps in Requirements for Safety Plans for Certain Drugs and Biologics
New FDAAA requirements being implemented
The U.S. Food and Drug Administration has identified 25 drugs and biologic products that will be required [...]

GOOD GRIEF! Mommy Alert!

Posted by H. Sandra Chevalier-Batik

Sherwood Brands Announces Nationwide Recall of
Pokémon Branded “Valentine Cards and Pops” —Because They May Contain Metal Fragments
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.
FOR IMMEDIATE RELEASE [...]

FDA Requiring Suicide Studies in Drug Trials

Posted by H. Sandra Chevalier-Batik

After decades of inattention to the possible psychiatric side effects of experimental medicines, the Food and Drug Administration is now requiring drug makers to study closely whether patients become suicidal during clinical trials.

The new rules represent one of the most profound changes of the past 16 years to regulations governing drug development. But [...]

FDA Takes Action Against Compounded Menopause Hormone Therapy Drugs

Posted by H. Sandra Chevalier-Batik

You’re Kidding Me — Right?
My first thought when this FDA Press Release crossed my screen was, “What does a multibillion-dollar, medical-pharmaceutical industrial complex buy with its obscenely high profits?” Apparently, the Federal agency that is chartered to oversee that very industry.
The fine hand of BIG PHARMA’s special-interest lobbing could not be more apparent in [...]

FDA Press Release — HPV (human papillomavirus)

Posted by H. Sandra Chevalier-Batik

What is HPV?
HPV (human papillomavirus) is a sexually transmitted virus. It is passed on through genital contact (such as vaginal and anal sex). It is also passed on by skin-to-skin contact. At least 50% of people who have had sex will have HPV at some time in their lives.
Why haven’t I heard of HPV?
HPV [...]

FDA Licenses New Vaccine for Prevention of Cervical Cancer and Other Diseases in Females Caused by Human Papillomavirus

Posted by H. Sandra Chevalier-Batik

Rapid Approval Marks Major Advancement in Public Health
FDA Press Release
June 8, 2006
Media Inquiries:
Julie Zawisza, 301-827-6242
Consumer Inquiries:
888-INFO-FDA
The Food and Drug Administration (FDA) today announced the approval of Gardasil, the first vaccine developed to prevent cervical cancer, precancerous genital lesions and genital warts due to human papillomavirus (HPV) types 6, 11, 16 and 18. The vaccine is [...]