Novadoz gets FDA green light for generic Thiotepa

Patients with a certain type of breast and ovary cancer will shortly have a new generic specialty injectable treatment available. The Food and Drug Administration has given Novadoz, an affiliate of MSN Labs, its blessing for generic Thiotepa 15 mg and 100 mg vials for injection. 

The product is indicated for the treatment of adenocarcinoma of the breast or ovary.

It is supplied as a powder for the solution in single-dose vials for intravenous, intracavitary, or intravesical use. The company expects the shipping of the product to commence shortly. 

The combined Thiotepa brand and generic have a market value of over $36.5 million for the previous 12 months, according to published sales data.

"MSN's approval for generic Thiotepa 15 mg and 100 mg vials for injection, increases the company's basket of specialty injectable products, moving forward our commitment to the generic oncology space.  As a first generic to the market, the 100 mg vial will provide substantial cost savings to oncology clinics, hospitals, and patients under a treatment regimen with the product.  Novadoz expects to add several more specialty injectables to our portfolio by the end of 2020," Seshu Akula, Novadoz president North America Generics said.