ANNOVERA

批准信原文要点

This Prior Approval sNDA provides for revisions to the following sections in the Prescribing Information: Highlights and Section 5, subsection 5.15 Toxic Shock Syndrome, to address postmarketing reports of toxic shock syndrome by Annovera users; Section 12, subsection 12.3 Pharmacokinetics, Tampon Use, to include the effects of Annovera and tampon co-usage.

批准信原文要点

We also refer to our Safety Labeling Change (SLC) letter dated November 18, 2021, notifying you, under Section 505(o)(4) of the FDCA, of new safety information that we believe should be included in the labeling for combined hormonal contraceptive (CHC) products. This information pertains to the risk of breast cancer, particularly with increased duration of use. This supplemental new drug application provides for revisions to the labeling for Annovera, consistent with our November 18, 2021, SLC letter.