Slayback Rivals Xiromed On Taytulla – But With First CGT Designation

Eligible For 180 Days Of CGT Exclusivity

US-based player Slayback “will kick off a full commercial launch under its own label very soon” of the generic version of Allergan’s Taytulla for which it has just received approval with a competitive generic therapy designation.

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The FDA finalized CGT guidance earlier this year • Source: Shutterstock

Slayback Pharma has championed the US Food and Drug Administration’s competitive generic therapy pathway after receiving approval for an AB-rated generic version of Allergan’s Taytulla (norethindrone acetate/ethinyl capsules; ferrous fumarate capsules) with the CGT designation, “less than eight months from filing.”

Final approval for Slayback’s abbreviated new drug application product, named Merzee, with a CGT designation brings the potential of 180 days of exclusivity, with the New

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