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: Extensive ANDA guidance is planned covering exclusivity, refuse-to-receive standards, bioequivalence, topical products, peptide drugs, DMFs, patent listing and pediatric exclusivity

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It is particularly effective when combined with another topical prescription medication, tretinoin, to enhance its absorption (and means that it can be applied once daily versus the normal twice daily application, and without the use of microneedle devices)

While the FDA's final decision is pending, this recommendation is a key regulatory step that could facilitate Vanta's planned peptide commercialization in the U.S