FDA Grants, Denies Provepharm ProvayBlue Petition

FDA has granted in part and denied in part a 2017 petition filed by Provepharm asking that the agency not approve any ANDA or NDA seeking approval of an injectable blue drug product unless the application contains specific information stated in the petition to show that the applicant’s drug is as safe as ProvayBlue (methylene blue) injection 0.5%. The agency says the petition is granted insofar as an ANDA that relies on ProvayBlue for the reference-listed drug is required to display labeling that is consistent with ProvayBlue regarding the Boxed Warnings, Contraindications, Warnings and Precautions, and Adverse Reactions unless a statutory or regulatory exception applies. In all other respects, FDA says, the petition is denied.

ProvayBlue was approved on 4/8/2016 to treat pediatric and adult patients with acquired methemoglobinemia, an orphan indication. Its orphan drug exclusivity expired on 4/8.