Amneal Biosciences announced the launch of Tepadina (thiotepa) for injection, the branded version of Thiotepa in both the 15mg/vial and 100mg/vial strength. Generic Thiotepa is already available as a 15mg/vial strength powder for IV, intravesical, or intracavitary administration.
Tepadina, an alkylating agent, is indicated to reduce the risk of graft rejection when used with high-dose busulfan and cyclophosphamide as a preparative regimen for allogeneic hematopoietic progenitor (stem) cell transplantation (HSCT) for pediatric patients with class 3 beta-thalassemia. Tepadina is also indicated to treat adenocarcinoma of the breast or ovary, for controlling intracavitary effusions secondary to diffuse or localized neoplastic diseases of various serosal cavities, and for treatment of superficial papillary carcinoma of the urinary bladder.
Amneal Biosciences President, Charles Lucarelli, stated, “We are thrilled to bring to the U.S. a product that is not only valuable to the pediatric transplant process, but in the 100mg vial that’s been unavailable for years. Now we have a fully FDA-approved thiotepa molecule with options for the reconstituting pharmacist.”
Tepadina is available as a 15mg and 100mg strength powder for reconstitution.
For more information call (844) 668-3940 or visit Amneal.com