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.
Apotex launches Teriparatide Injection in US
Teva Pharmaceuticals secures FDA approval for generic Forteo (teriparatide injection)
Upsher-Smith Laboratories introduces Pitavastatin Tablets
Par Pharmaceutical starts shipping colchicine 0.6mg capsules
Padagis launces Brinzolamide Ophthalmic Suspension with CGT exclusivity
Novartis completes Sandoz Spin-off
Novartis completes Sandoz spin-off, focusing on innovative medicines
Sanofi and Teva collaborate on innovative IBD treatment
Hikma marks KLOXXADO two-year anniversary by surpassing 375,000 doses donated in the US
STADA seeks full approval for Kinpeygo in IgA nephropathy from UK MHRA
Azurity Pharmaceuticals completes Slayback Pharma acquisition
Sandoz secures European approval for Tyruko biosimilar in MS treatment
Senores Pharmaceuticals introduces Nicardipine Hydrochloride Capsules USP, 20mg and 30mg in US
Lupin collaborates with Mark Cuban Cost Plus Drug Company and COPD foundation
Certara Simcyp receives FDA grants for advanced pharmacokinetic modelling