InnoPharma, Inc. today announced the approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (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.
"We are excited to see this important product reach the market. This approval further emphasizes InnoPharma's ability and commitment to develop and bring to market complex generic and innovative specialty pharmaceutical products," stated Navneet Puri, Ph.D., President and Chief Executive Officer of InnoPharma.
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. (NYSE: 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.