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InnoPharma : FDA Okays Decitabine For Injection, Generic Version Of Dacogen
[August 29, 2014]

InnoPharma : FDA Okays Decitabine For Injection, Generic Version Of Dacogen


(dpa-AFX International Compact Via Acquire Media NewsEdge) NEW YORK CITY (dpa-AFX) - InnoPharma Inc. announced that the U.S. Food and Drug Administration has approved its Abbreviated New Drug Application or ANDA for decitabine for injection, a generic version of Eisai Inc.'s Dacogen.



InnoPharma developed the generic formulation of decitabine for injection and entered into an agreement with Sandoz, Inc., pursuant to which Sandoz will sell, market and distribute decitabine for injection in the United States.

According to IMS data, aggregate U.S. sales of Dacogen were approximately $251 million for the twelve months ending in April 2014.


Decitabine for injection is indicated for the treatment of patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups.

The company noted that Decitabine for injection will be marketed in 20 mL single dose glass vials containing 50 mg decitabine, the same size and strength as the brand. The dosing regimen is identical to the brand.

On July 16, 2014, Pfizer Inc. (PFE) and InnoPharma announced that they have entered into an agreement under which Pfizer will acquire InnoPharma. The closing of the transaction is subject to U.S. regulatory approval and is expected to occur during the third quarter.

Copyright RTT News/dpa-AFX

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