The FDA has given tentative approval for Eagle Pharmaceuticals Inc.'s (EGRX) investigational drug for the treatment of Indolent B-cell non-Hodgkin lymphoma.
The approved (tentatively approved) product of Eagle Pharma is a ready to dilute version of Bendamustine Hydrochloride Injection.
Bendamustine Hydrochloride Injection is currently marketed by Cephalon, a wholly-owned subsidiary of Teva Pharmaceuticals, under the brand name Treanda.
Treanda is indicated for the treatment of chronic lymphocytic leukemia and non-Hodgkin's lymphoma, and it generated sales of $694 million for the twelve-month period ended April 2014, based on industry sales data.
Given the fact that the orphan drug and related pediatric exclusivity for Treanda expires only in September 2015 and May 2016, respectively, a patent infringement lawsuit against Eagle Pharma was filed by Teva on October 21, 2013 when the New Drug Application for ready-to-dilute Bendamustine Hydrochloride Injection was filed by Eagle Pharma last September.
So until the patent and exclusivity issues are resolved, Eagle Pharma's ready-to-dilute Bendamustine Hydrochloride Injection is not eligible for marketing in the U.S., and hence the tentative approval.
Eagle Pharma has another catalyst coming its way - the FDA decision on its product candidate Ryanodex for the treatment of malignant hyperthermia, which is scheduled for July 22, 2014.
Malignant hyperthermia is a potentially fatal, inherited disorder causing a rapid rise in body temperature (fever) and severe muscle contractions associated with administration of certain general anesthetics and/or the drug succinylcholine.
Will the FDA give green signal to Ryanodex? Stay tuned...
by RTT Staff Writer
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