Pink Sheet is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

MEAD JOHNSON’s ESTRACE ADDS POSTMENOPAUSAL OSTEOPOROSIS INDICATION

Executive Summary

MEAD JOHNSON's ESTRACE ADDS POSTMENOPAUSAL OSTEOPOROSIS INDICATION at a starting dose of .5 mg daily for three weeks followed by a one-week period off the drug. FDA cleared the supplemental NDA for 17-beta-estradiol on Sept. 8, about six-and- a-half years after the initial filing of the application. Estrace was originally approved in mid-1975 for treatment of vasomotor symptoms associated with menopause. Estrace is not currently available in .5 mg individual tabs; the product is supplied as 1 mg and 2 mg scored tablets. The osteoporosis dosing information notes that Estrace dosages "may be adjusted if necessary to control concurrent menopausal symptoms." FDA approved labeling does not refer directly to clinical results from use of Estrace for osteoporosis. The company's introductory promotional material for the drug, however, cites two 18-month clinical studies involving 51 women. The studies were conducted at the Kaiser Permanente Medical Care Program in Oakland, and The University of California-San Francisco. Estrace therapy showed an increase of bone mass in postmenopausal women compared to placebo recipients. Patients given 2 mg of Estrace had a 2.5% increase in bone mass and those given 1 mg showed a 1.8% increase. Patients receiving .5 mg (the approved dosage) had bone mass increases of .3%. By comparison, women taking placebo recorded a 4.9% bone mass decrease. All patients in the studies, including placebo recipients, were also taking calcium supplements. Mead Johnson Labs notes that Estrace is the only oral estrogen replacement therapy that contains only 17-beta-estradiol. Synthetically produced, Estrace is chemically identical to the primary estrogen that is produced naturally by human ovaries, the firm says.
Advertisement
Advertisement
UsernamePublicRestriction

Register

PS021531

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel