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news.The US Food and Drug Administration (FDA) has granted approval to InnoPharma's abbreviated new drug application (ANDA) for decitabine for injection.
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Decitabine for injection is a generic version of Japanese pharmaceutical firm Eisai’s Dacogen.
The drug is used to treat patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups.
Dacogen had aggregate US sales of about $251m for the twelve months ending in April 2014, according to IMS data.
InnoPharma had entered into an agreement with Sandoz to sell, market and distribute the generic formulation of decitabine for injection in the US.
InnoPharma president and chief executive officer Navneet Puri said, "This approval further emphasizes InnoPharma’s ability and commitment to develop and bring to market complex generic and innovative specialty pharmaceutical products."
The company said that decitabine for injection will be marketed in 20mL single dose glass vials containing 50mg decitabine, the same size and strength as the brand.
In July this year, Pfizer has entered into an agreement under to acquire InnoPharma and the closing of this transaction is subject to US regulatory approval and is expected to occur during the third quarter.