BN Business News
Add your company to Business Communicator →

Zdrowie i gospodarka · 12/12/2025

FDA Clears Path for LUNELLE Injectable, 5 mg/0.5 mL, for Approval via ANDAs

The FDA has determined that LUNELLE (estradiol cypionate and medroxyprogesterone acetate) injectable, 5 mg/0.5 mL, was not withdrawn from sale for safety or effectiveness reasons. This decision allows the FDA to approve ANDAs for estradiol cypionate and medroxyprogesterone acetate injectable, 5 mg/0.5 mL, if all other requirements are met.

Source: Federal Register — Food and Drug AdministrationOpen original release →