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# FDA Nixes Eagle Pharma Orphan Exclusivity Request
- URL: https://www.fdaweb.com/fda-nixes-eagle-pharma-orphan-exclusivity-request/
- Published: 2016-03-28T12:00:00.000Z
- Updated: 2026-09-14T20:51:22.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135197

> FDA has denied an Eagle Pharmaceuticals request for seven years orphan drug exclusivity for Bendeka (bendamustine HCI), a liquid, low-volume (50 mL) 10-minute infusion for treating chronic lymphocytic leukemia (CLL) and indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. Eagle believes that the agency’s decision is incorrect, and that it was automatically entitled to orphan drug exclusivity for CLL and indolent B-cell NHL upon the drug’s 12/2015 approval.  
>  
> Bendeka’s active ingredient was previously approved, and FDA currently requires sponsors of such orphan-designated drugs to make a “clinical superiority” demonstration as a condition to obtaining the seven-year exclusivity period upon approval ([see earlier story](http://fdaweb.com/login.php?sa=v&aid=D5130801&searchWords=GRALISE&cate=S&stid=%241%24204.h%2F..%24FjFum%2F3XMRVwbs9i7kzQZ0&ref=fdaweb.com)). In 2014, DepoMed [prevailed in federal court](http://fdaweb.com/login.php?sa=v&aid=D5129800&searchWords=GRALISE&cate=S&stid=%241%24204.h%2F..%24FjFum%2F3XMRVwbs9i7kzQZ0&ref=fdaweb.com) after challenging the agency’s application of this clinical superiority demonstration requirement to its orphan-designated drug product, Gralise. Eagle says the current rejection “closely mirrors” the decision in the DepoMed litigation, and it says it is “evaluating all options to obtain a reversal of the FDA’s Bendeka decision at this time.”