Novadoz Increases Receives FDA Approval of Thiotepa Vials for Injection

Novadoz Pharmaceuticals received FDA approval for their generic version of Thiotepa 15mg and 100mg vials for injection. The product is supplied as a powder for solution in single-dose vials for intravenous, intracavitary, or intravesical use. The company expects shipping of the product to commence shortly. The combined Thiotepa brand and generic sales are trending over $36.5mil during the previous 12 months according to recent published sales data.

Thiotepa for injection is indicated for treatment of adenocarcinoma of the breast or ovary. The recommended dose of Thiotepa for injection for treatment of adenocarcinoma of the breast or ovary is 0.3 to 0.4 mg/kg intravenously. Doses should be given at 1 to 4 week intervals. Initially the higher dose in the given range is commonly administered. The maintenance dose should be adjusted weekly based on pretreatment control blood counts and subsequent blood counts. Maintenance doses should not be administered more frequently than weekly. Healthcare professionals should refer to the company's prescribing information prior to administering this medication.

"MSN's approval for generic Thiotepa 15mg & 100mg 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 100mg vial will provide a 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.

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