News Releases--Women's Health

 

For media inquiries about the FDA, the Office of Women's Health, or women's health issues, please contact FDA's Office of Public Affairs: 301-796-4540.

 

FDA News Releases for 2012:

• FDA approves Afinitor for advanced breast cancer (July 20)
• Updated FDA Statement on Compounded Versions of hydroxyprogesterone caproate (the active ingredient in Makena) (June 15)
• FDA approves Perjeta for type of late-stage breast cancer (June 8)
• U.S. Marshals seize ultrasound gel product at a New Jersey Company (April 18)
• FDA approves first Boniva generics to treat or prevent osteoporosis (March 19)
• FDA approves new silicone gel-filled breast implant (March 9)

 

FDA News Releases for 2011:

• Statement from FDA Commissioner Margaret Hamburg, M.D. on Plan B One-Step (December 7)
• FDA Commissioner announces Avastin decision (November 18)
• Unapproved emergency birth control medicine possibly in U.S. distribution may be ineffective and unsafe (July 28) 
• FDA: Surgical placement of mesh to repair pelvic organ prolapse poses risks (July 13)
• FDA provides updated safety data on silicone gel-filled breast implants (June 22)
• FDA approves new test to help determine if breast cancer patients are candidates for Herceptin treatment
  (June 14)
• FDA: Breast thermography not a substitute for mammography (June 2)
• FDA: Do not feed SimplyThick to premature infants (May 20)
• FDA approves Benlysta to treat lupus (March 9)
• FDA Drug Safety Communication: New warnings against use of terbutaline to treat preterm labor (February 17)
• FDA approves first 3-D mammography imaging system (February 11)
• FDA approves drug to reduce risk of preterm birth in at-risk pregnant women (February 4)
• FDA review indicates possible association between breast implants and a rare cancer (January 26)

 

FDA News Releases for 2010:

• FDA begins process to remove breast cancer indication from Avastin label (December 16)
• FDA approves new treatment option for late-stage breast cancer (November 15)
• FDA: Possible increased risk of thigh bone fracture with bisphosphonates (October 13)
• FDA approves ella tablets for prescription emergency contraception (August 13)
• FDA Approves New Injectable Osteoporosis Treatment for Postmenopausal Women (June 1)
• FDA: Rare Cases of Liver Injury Reported with Use of Xenical, Alli (May 26)
• FDA Approves New Combination Product Oral Contraceptive (May 6)
• FDA Expands Use of Approved Breast Cancer Drug (January 29)
• FDA Warns Consumers about Counterfeit Alli (January 18)

 

FDA News Releases for 2009:

• FDA Approves New Vaccine for Prevention of Cervical Cancer (October 16)
• FDA Approves New Indication for Gardasil to Prevent Genital Warts in Men and Boys (October 16)
• FDA Approves Additional Use for IUD Mirena to Treat Heavy Menstrual Bleeding in IUD Users  (October 1)
• FDA Clears a Test for Ovarian Cancer (September 11)
• FDA Gives Update on Botulinum Toxin Safety Warnings (August 3)
• FDA Approves Generic Prescription-Only Version of Plan B (June 24)
• FDA Alerts Patients to Medtronic Pacemaker Recall (June 11)
• FDA Warns Consumers to Stop Using Hydroxycut Products (May 1)
• Updated FDA Action on Plan B (April 22)
• FDA Discovers Additional Tainted Weight Loss Products (March 20)
• FDA Approved First DNA Test for Two Types of Human Papillomavirus (March 13)
• FDA Alerts Public about Danger of Skin Numbing Products (Jan. 16)

 

FDA News Releases for 2008:

• FDA Expands Warning to Consumers about Tainted Weight Loss Pills (Dec 22)
• FDA Issues Warning Letters to Bayer Healthcare for Illegally Marketing Two Unapproved Drugs (Oct. 28)
• FDA Issues Health Information Advisory on Infant Formula (Sept. 12)
• FDA Approves Expanded Uses of Gardasil to Include Preventing Certain Vulvar and Vaginal Cancers (Sept. 12)
• FDA Proposes New Rule to Provide Updated Information on the Use of Prescription Drugs and Biological Products during Pregnancy and Breast-feeding (May 28)
• FDA Warns Consumers Against Using Mommy's Bliss Nipple Cream (May 23)
• FDA Approves Update to Label on Birth Control Patch (Jan 18)
• FDA Takes Action Against Compounded Menopause (Jan. 9)