FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: DETERMINATION THAT LUNELLE (ESTRADIOL CYPIONATE AND MEDROXYPROGESTERONE ACETATE) INJECTABLE, 5 MILLIGRAMS/0.5 MILLILITER AND 25 MILLIGRAMS/0.5 MILLILITER, WAS NOT WITHDRAWN FROM SALE FOR REASONS OF SAFETY OR EFFECTIVENESS

WASHINGTON, Dec. 12 -- Food and Drug Administration has issued a notice called: Determination That LUNELLE (Estradiol Cypionate and Medroxyprogesterone Acetate) Injectable, 5 Milligrams/0.5 Milliliter and 25 Milligrams/0.5 Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness.

The notice was published in the Federal Register on Dec. 12 by Lowell M. Zeta, Acting Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA or Agency) has determined that LUNELLE (estradiol cypionate and medroxyprogesterone acetate) injectable, 5 milligrams (mg)/0.5 milliliter (mL) estradiol cypionate and 25 mg/0.5 mL medroxyprogesterone acetate, was not withdrawn from sale for...