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# FDA Denies Teva Petition on Treanda ANDAs
- URL: https://www.fdaweb.com/fda-denies-teva-petition-on-treanda-andas/
- Published: 2016-03-25T12:00:00.000Z
- Updated: 2026-09-14T20:51:06.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135192

> FDA has denied a 2015 Teva [petition](http://www.regulations.gov/contentStreamer?documentId=FDA-2015-P-3980-0001&attachmentNumber=1&disposition=attachment&contentType=pdf&ref=fdaweb.com) asking it not to approve any ANDAs that reference Treanda (bendamustine hydrochloride) until its orphan exclusivity for indolent B-cell non-Hodgkin’s lymphoma (iNHL) has expired. FDA approved Treanda in 3/2008 for treating chronic lymphocytic leukemia (CLL). The orphan exclusivity for the CLL use expired on 9/20/2015\. The second indication for treating iNHL was approved 10/2008, and its orphan exclusivity expires 5/1/2016.  
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> Teva said it was concerned that an ANDA applicant may ask to “carve out” the iNHL information from its labeling and seek approval only for CLL before the iNHL orphan exclusivity expires. “The orphan exclusivity, however, covers the approval of the drug for iNHL, including all data needed to demonstrate the safety and effectiveness of the drug for that use,” the petition argued. “To allow an ANDA applicant to omit the iNHL indication, but otherwise refer to the use of bendamustine for iNHL and related data elsewhere in the labeling, would be contrary to the Orphan Drug Act.”  
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> In denying the petition, the agency said it disagreed with Teva’s assertion that it cannot approve an ANDA for the non-protected CLL indication until Treanda’s orphan exclusivity for the iNHL indication expires. “The myelosuppression risk information in Treanda’s labeling is not protected by Treanda’s orphan drug exclusivity and therefore need not be omitted on this basis from the labeling of a proposed generic drug that relies upon Treanda,” it says. Additionally, it says it can permit minor modification to the labeling of such ANDAs to convey safety information pertaining to the myelosuppression risks without disclosing the iNHL indication.