Prasco agrees to distribute authorized generic of Pentasa

CINCINNATI — Prasco Labs will distribute an authorized generic version of an ulcerative colitis treatment made by Shire in the event that any other company steps forward to file an abbreviated new drug application for the drug.

Prasco announced an agreement with Shire US Manufacturing for mesalamine controlled-release capsules, an authorized generic of Shire’s Pentasa, in the 250-mg and 500-mg strengths, whereby Prasco will distribute the authorized generic when the Food and Drug Administration approves a generic version of the drug. At present, no generic version is available.

An authorized generic is a branded drug sold under its generic name at a discounted price, usually as part of an agreement between the branded drug’s manufacturer and a third-party company.