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CINCINNATI — Prasco Laboratories has entered a distribution and supply pact with Shire US Manufacturing Inc. for mesalamine controlled-release capsules.
Prasco said Tuesday that under the agreement, it’s set to market the authorized generic version of Pentasa (mesalamine) controlled-release capsules, at Shire’s request, upon any entrance into the U.S. market of an approved abbreviated new drug application (ANDA) for any generic mesalamine product that’s AB-rated to Pentasa.
Currently, the Food and Drug Administration hasn’t approved any ANDA for Pentasa, a registered trademark of Ferring A/S Corp., according to Prasco.
The authorized generic would be marketed in the United States in 250-mg and 500-mg strengths under the Prasco label.
"We are excited to have established this new business relationship with Shire," stated Prasco chief executive officer E. Thomas Arington. "Patients and pharmacists alike benefit when a company such as Shire commits to maintaining the supply of brand-identical medication through the Prasco authorized generic business model."
Mesalamine is used to treat mildly to moderately active ulcerative colitis as well as to prevent the symptoms of ulcerative colitis from recurring.
