Novadoz/MSN Labs Receives FDA Clearance for Fosaprepitant, Decitabine

Novadoz Pharmaceuticals, the U.S based sales & marketing affiliate for MSN Labs, based in Hyderabad India, has received FDA approvals for their generic versions of Decitabine and Fosaprepitant for injection. The company has immediately commenced shipping of Fosaprepitant, which coincides with the first day of patent expiration for the brand EMEND©, marketed by Merck. Novadoz expects to begin the shipping of Decitabine, their generic version of DACOGEN© from Otsuka, later this month.

The combined sales of Decitabine brand and generics is trending over $91MIL, while brand sales of Fosaprepitant are approximately $279MIL during the previous twelve months of published sales. 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 approval of Fosaprepitant and Decitabine for injection, mark the company's entrance into the specialty injectable market," Seshu Akula, Novadoz President North America Generics, 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."

MSN Labs is engaged in the development and manufacturing of API (active pharmaceutical ingredients), KSMs (key starting materials), and product intermediates. MSN is a global leader in this category. In addition, the company manufactures finished dosage oral solids, liquids, and injectable products in sixty-five markets throughout the world, doing business in the U.S under the Novadoz label.

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