Connetics files citizen petition for Soriatane with FDA

New York, April 3 - Connectics Corp. said it filed a citizen petition with the Food and Drug Administration requesting that any generic products that reference Soriatane (acitretin) meet several criteria in addition to rigorous bioequivalency testing prior to approval.

The company said the criteria in its petition "will ensure that patients are adequately protected from generic versions of acitretin that might not be comparable in safety and efficacy to the branded product."

Subtle differences between Soriatane and a generic acitretin that change the extent or route of metabolism, absorption, distribution or elimination of acitretin can significantly increase the risks associated with the well-known conversion of acitretin to the potent teratogen, etretinate, and therefore reduce the effectiveness of current safeguards to manage these risks, the company explained in a press release.

"In the citizen petition, Connetics has outlined certain tests we strongly believe the FDA should require of any company to ensure its generic product is the same as Soriatane with regard to important attributes that are related to product safety," said Thomas Wiggans, chairman and chief executive officer of Connetics, in a news release.

"Typically, a few basic bioequivalency tests are required for an amended New Drug Application. But the overall pharmacologic equivalence of a generic takes on greater significance for a product with the chemical complexities of acitretin, which directly impact the way it can be most safely used."

Soriatane is a once-daily oral retinoid medication for the treatment of severe psoriasis in adults.

Connetics is a Palo Alto, Calif., specialty pharmaceutical company.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.