Decitabine and Fosaprepitant Generics Approved by FDA

September 6, 2019

First generic specialty injections approved for Novadoz Pharmaceuticals. 

Generic versions of decitabine and fosaprepitant specialty injections were granted FDA approval. 

The new approvals are the first generic specialty injections for Novadoz Pharmaceuticals, the U.S.-based sales and marketing affiliate for MSN Laboratories based in Hyderbad, India.

Fosaprepitant is a substance P/neurokin-1 receptor agonist, approved in 2008 for the treatmen of adults and pediatric patients at least 6 months of age, in combination with other antiemetic agents for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses highly and moderately emetogenic cancer chemotherapy. 

 

See Full Prescribing Information (Fosaprepitant)

Decitabine is a nucleoside metabolic inhibitor approved in 2008 for the treatment of adult patients with myelodysplastic syndromes (MDS) including previously treated and underrated, 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, intemediate-2, and high-risk International Prognostic Scoring System groups.

 

See Full Prescribing Information (Decitabine)

The company announced in a press release that it has immediately begun shipping generic version of fosaprepitant, which coincide with the first day of Emend’s patent expiration (Sept. 5th), previously marketed by Merck. Shipments for decitabine will begin later in September, the company says.