FDA approves two generic injectables from Novadoz Pharmaceuticals

The Hyderabad, India-based affiliate of Novadoz, MSN Labs, has received approval for Decitabine and Fosaprepitant and immediately commenced shipping of the latter

Novadoz Pharmaceuticals, the US-based sales & marketing affiliate for MSN Labs, based in Hyderabad, India, has received FDA approvals for its generic versions of Decitabine and Fosaprepitant for injection. Decitabine was approved on 29 August, and Fosaprepitant gained clearance 5 September. 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 US$91 million, while brand sales of Fosaprepitant are approximately $279m during the previous twelve months of published sales. Decitabine is available as 50 mg 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 sterile, lyophilised formulation available as a single vial, and indicated to prevent acute and delayed nausea and vomiting associated with initial and repeat courses of chemotherapy.

Seshu Akula, Novadoz President North America Generics, said: "The approval of Fosaprepitant and Decitabine for injection, mark the company's entrance into the speciality injectable market. The introduction of Fosaprepitant, as well as our earlier approvals for Abiraterone, and Capecitabine, further the organisation'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 speciality products."

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