2005P-0441 Reservoir Systems for Transdermal Delivery
FDA Comment Number : EC1
Submitter : Mrs. Sheila Sorensen Date & Time: 12/19/2005 01:12:37
Organization : Mrs. Sheila Sorensen
Category : Individual Consumer
Issue Areas/Comments
GENERAL
GENERAL
Dear Sir or Madam:
My name is Sheila Sorensen and I have been taking bioidentical hormones for seven months. It is been a tremendous comfort to me as it alleviates negative symtoms associated with uturine fybroids.
I consult with my physician, who prescribes bio-identical hormones specifically for me, and my pharmacist prepares them. Without this medication, my periods were unbearable, and the fibroids in my uterous may prevent pregnancy.
The benefit of BHRT is that it is designed for me and I am concerned that Wyeth's petition (DOcket # 2005P-0411) would limit the ability of my physician and pharmacist to keep prescribing and preparing these individualized doses for me. The FDA should reject Wyeth's petition.
Sincerely,
Sheila Sorensen
Santa Rosa, California