Previous Posts
- This blog has moved
- Avandia Given Positive Reviews Due to $$$$$?
- The FDA and Drug Approval
- J&J Planned Profit from Risky, Unapproved Uses of ...
- What Are the Different Classes of Drug Recalls?
- What Is the Difference Between Class Action and Mu...
- First Lawsuit for Avandia Filed In Santa Clara Cou...
- Our Involvement in the Yaz®/Yasmin® Litigation
- What Is An FDA Black Box Warning?
- What Is a Drug Recall?
Archives
- April 2008
- May 2008
- May 2009
- June 2009
- July 2009
- August 2009
- September 2009
- October 2009
- November 2009
- December 2009
- January 2010
- February 2010
- March 2010
- April 2010
Click Here to View
Our Other Site
Thursday, June 25, 2009
FDA Approves Generic Version of Plan B Emergency Contraceptive
Today the FDA approved the first generic version of Plan B, an emergency contraceptive tablet that contains 0.75 mg of Levonorgestrel. The generic product will only be available by prescription for women ages 17 and under.
Plan B, which is manufactured by Duramed Pharmaceuticals Inc., was first approved in 1999. Women of all ages were able to access Plan B by prescription only. In 2006, Plan B was approved for non-prescription use for women ages 18 and older. However, Plan B still remained available as a prescription- only product for women ages 17 and under. Today’s approval allows marketing of a prescription-only generic product for women ages 17 and under. No generic Levonorgestrel product for emergency contraception can be approved for non-prescription use in women ages 18 and older until August 24, 2009, when the marketing exclusivity held by Duramed Pharmaceuticals for the non-prescription use expires.
Plan B, which is manufactured by Duramed Pharmaceuticals Inc., was first approved in 1999. Women of all ages were able to access Plan B by prescription only. In 2006, Plan B was approved for non-prescription use for women ages 18 and older. However, Plan B still remained available as a prescription- only product for women ages 17 and under. Today’s approval allows marketing of a prescription-only generic product for women ages 17 and under. No generic Levonorgestrel product for emergency contraception can be approved for non-prescription use in women ages 18 and older until August 24, 2009, when the marketing exclusivity held by Duramed Pharmaceuticals for the non-prescription use expires.
Plan B is available to women 18 and older over the counter. Levonorgestrel can prevent pregnancy after unprotected intercourse or a known or suspected contraceptive failure. It is not effective in preventing or protecting against sexually transmitted disease. The most common side effects to taking Plan B include: nausea, abdominal pain, fatigue, headaches, a heavier menstrual period, vomiting, and dizziness.
For additional information see: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm168870.htm
Labels: emergency contraceptive, FDA, Plan B, pregnancy, prescription
posted by
Chavon Williams
at
8:22 AM
