Eli Lilly & Co. and Bristol-Myers Squibb Co.; Withdrawal of Approval of Three New Drug Applications for Estrogen-Androgen Combination Drugs

摘要

The Food and Drug Administration (FDA) is withdrawing approval of three new drug applications (NDA's) for estrogen-androgen combination drugs. The NDA's are held by Eli Lilly & Co. and Bristol- Myers Squibb Co. The products are no longer marketed. Both companies requested that the NDA's be withdrawn and waived their opportunity for a hearing. The products will be removed from the list of drug products with effective approvals.