Novadoz/MSN Labs get FDA nod for two generic specialty injectables

Novadoz, the U.S. based sales and marketing affiliate of MSN Labs, has received the Food and Drug Administration's blessing for decitabine and fosaprepitant.

Fosaprepitant is the generic of Merck’s Emend and Decitabine is the generic of Otsuka’s Dacogen.

The decitabine brand and generics have a market value of over $91 million, while fosaprepitant has a brand market of approximately $279 million for the latest 12-month period, the company said.

Decitabine is available as a 50 mg single-dose vial. It is 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 sterile, lyophilized formulation available as a single vial. It is indicated to prevent acute and delayed nausea and vomiting associated with initial and repeat courses of chemotherapy.

"The approval of fosaprepitant and decitabine for injection mark the company's entrance into the specialty injectable market," Novadoz president of North America generics Seshu Akula said. "The introduction of fosaprepitant, as well as our earlier approvals for abiraterone and capecitabine, further the organization's commitment to be a leading supplier of oncology products. We expect several additional approvals over the next year, adding to our growing line of specialty products."