FDA approval of generic cancer drug Doxil is expected to help resolve shortage

The US Food and Drug Administration has approved the first generic version of the cancer drug Doxil (doxorubicin hydrochloride liposome injection), from US health care giant Johnson & Johnson’s (NYSE: JNJ) Janssen subsidiary.

The generic is made by India-based Sun Pharmaceutical (SUNP: IN), whose doxorubicin hydrochloride liposome injection is administered intravenously by a health care professional. Sun’s generic will be available in 20 milligram and 50 milligram vials, the FDA noted. Sun’s shares rose as much as 4.5% to 752.10 rupees on the news.

Doxorubicin hydrochloride liposome injection is currently on the FDA’s drug shortage list. For products on the shortage list, the FDA’s Office of Generic Drugs is using a priority review system to expedite the review of generic applications to help alleviate shortages.