Novadoz Pharmaceuticals reported on Friday the receipt of approval from the FDA for the generic version of Thiotepa in the 15mg and 100mg vials for injection indicated for treatment of adenocarcinoma of the breast or ovary.

The company added that Thiotepa is supplied as a powder for solution in single-dose vials for intravenous, intracavitary, or intravesical use. 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. The maintenance dose should be adjusted weekly based on pretreatment control blood counts and subsequent blood counts.

In addition, the company expects shipping of Thiotepa to commence shortly.

For the prior 12 months, the combined Thiotepa brand and generic sales are trending over USD36.5m, according to published sales data.

Novadoz Pharmaceuticals is the US-based sales & marketing affiliate for MSN Labs, based in Hyderabad India, which is engaged in the development and manufacturing of API (active pharmaceutical ingredients), KSMs (key starting materials) and product intermediates.