FDA approves NDA for Teva's topotecan injection

SILVER SPRINGS, Md. — Teva Pharmaceuticals has received approval of their new drug application for topotecan hydrochloride injection, a treatment for small cell lung cancer, according to Food and Drug Administration records.

The NDA provides for the use of topotecan hydrochloride injection in the 1 mg/mL strength in the treatment of chemotherapy-sensitive small cell lung cancer after failure of first-line chemotherapy and, in combination with cisplatin, for the treatment of stage IV-B, recurrent or persistent carcinoma of the cervix, cancer not amenable to curative treatment with surgery or radiation therapy.

As DSN reported in early December, the generic topotecan hydrochloride injection is also produced by Sagent Pharmaceuticals and is a version of GlaxoSmithKline’s Hycamtin.