PristiqTreatment for Depression
Update: Pristiq (desvenlafaxine) Now FDA Approved for Depression - February 29, 2008
Wyeth Submits Two New Drug Applications for Women's Health Therapies
Simultaneous Initial Submissions Represent a Company First and Wyeth's Ongoing Commitment to Leadership in Women's Health
MADISON, N.J., June 26, 2006 -- Wyeth Pharmaceuticals, a division of Wyeth , announced today that the Company has submitted two New Drug Applications (NDA) to the U.S. Food and Drug Administration (FDA). The first NDA is for the approval of bazedoxifene, a Selective Estrogen Receptor Modulator (SERM) investigated for the prevention of postmenopausal osteoporosis. The second NDA is for desvenlafaxine succinate, a non-hormonal agent studied for the treatment of moderate to severe vasomotor symptoms associated with menopause, such as hot flashes and night sweats.
"If approved, both bazedoxifene and desvenlafaxine succinate will give physicians additional options to help meet the individualized needs of their menopausal patients," says Joseph Camardo, MD, Senior Vice President, Global Medical Affairs, Wyeth Pharmaceuticals. "The simultaneous submission of these two separate NDAs emphasizes Wyeth's position as a leader and innovator in women's health. Wyeth continues to support clinical research and drug development with the goal of meeting the health care needs of women worldwide."
During menopause women begin losing bone mass more rapidly, making them increasingly susceptible to osteoporosis. According to the National Osteoporosis Foundation the number of women of menopausal age who have osteoporosis or are at risk for developing the disease will increase from almost 30 million in 2002 to nearly 41 million in 2020.
About Vasomotor Symptoms
According to the North American Menopause Society, there are approximately 40 million women in the United States of menopausal age. As many as 93 percent of women going through menopause experience vasomotor symptoms such as hot flashes, which can greatly impact a woman's life. However, many women remain untreated for their vasomotor symptoms.
Source: Wyeth Pharmaceuticals
Posted: June 2006
- FDA Approves Pristiq for the Treatment of Adult Patients with MajorDepressive Disorder - March 3, 2008
- Wyeth Receives Approvable Letter from FDA for Pristiq for the Treatment of Vasomotor Symptoms Associated with Menopause - July 24, 2007
- Wyeth Receives Approvable Letter From FDA for Pristiq (Desvenlafaxine Succinate) for the Treatment of Major Depressive Disorder - January 23, 2007
- Re-formatted Data Submission Results in Extension of FDA Review for Desvenlafaxine Succinate - August 29, 2006
- FDA Cancels Advisory Committee Meeting to Review Desvenlafaxine Succinate Data for Major Depressive Disorder - August 22, 2006
- Wyeth Submits New Drug Application for Desvenlafaxine Extended Release (DVS-233) for Depression - December 22, 2005