Novadoz Pharmaceuticals awarded FDA clearance for Fosaprepitant and Decitabine generics
6 September 2019 -

Pharmaceutical company Novadoz Pharmaceuticals and MSN Labs jointly reported on Thursday the receipt of approvals from the US Food and Drug Administration (FDA) for their generic versions of Decitabine and Fosaprepitant for injection.

Decitabine is available as 50mg single-dose vial used to treat a group of blood/bone marrow disorders in cases when bone marrow does not produce enough healthy blood cells. Fosaprepitant is a is a sterile, lyophilized formulation available as a single vial, and indicated to prevent acute and delayed nausea and vomiting associated with initial and repeat courses of chemotherapy.

The companies have commenced the shipment of Fosaprepitant effective immediately, coinciding with the first day of patent expiration for the brand EMEND, marketed by Merck.

Later this month, the companies expects to begin the shipment of Decitabine, the generic version of DACOGEN from Otsuka.

According to the companies, the combined sales of Decitabine brand and generics is trending over USD91m, while brand sales of Fosaprepitant are approximately USD279m during the prior 12 months of published sales.