2025-22680: 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and Medroxyprogesterone Acetate) Injectable, 5 Milligrams/0.5 Milliliter and 25 Milligrams/0.5 Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
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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5 milligrams (mg)/0.5 milliliter (mL) estradiol cypionate and 25 mg/0.5 mL medroxyprogesterone acetate, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for estradiol cypionate and medroxyprogesterone acetate injectable, 5 mg/0.5 mL estradiol cypionate and 25 mg/0.5 mL medroxyprogesterone acetate, if all other legal and regulatory requirements are met.
The agency’s own summary, as published.
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