SOLOSEC

批准信原文要点

These Prior Approval supplemental new drug applications provide for the addition of female patients 12 to less than 18 years of age to the approved indication for treatment of bacterial vaginosis (S-014) and the addition of patients 12 to less than 18 years of age to the approved indication for treatment of trichomoniasis caused by Trichomonas vaginalis (S-016).

批准信原文要点

These Prior Approval supplemental new drug applications provide for the addition of female patients 12 to less than 18 years of age to the approved indication for treatment of bacterial vaginosis (S-014) and the addition of patients 12 to less than 18 years of age to the approved indication for treatment of trichomoniasis caused by Trichomonas vaginalis (S-016).

批准信原文要点

This supplemental new drug application provides for revisions to the labeling for Solosec consistent with our September 01, 2021, safety labeling change notification letter.

批准信原文要点

This Prior Approval supplemental new drug application provides for a new indication, for the treatment of trichomoniasis caused by Trichomonas vaginalis in adults.

批准信原文要点

This Prior Approval sNDA provides for the following revisions to the Prescribing Information (PI) as requested by the Agency in the February 26, 2021, supplement request letter. (1) The DOSAGE AND ADMINISTRATION (2) section, Instructions for the Preparation and Administration of SOLOSEC (2.2) subsection, was updated to include the following text: Avoid consumption of alcoholic beverages and preparations containing ethanol or propylene glycol during treatment with SOLOSEC and for at least 2 days after completing therapy. (2) The ADVERSE REACTIONS (6) section, Postmarketing Experience (6.2) subsection was revised to state that Nausea, vomiting, diarrhea, abdominal pain, dizziness, and headache have been reported when SOLOSEC was taken concomitantly with alcohol. (3) Under the DRUG INTERACTIONS (7) section, an Alcohol (7.2) subsection was added