ANDA Accepted for Generic Doxil Injection
Merrimack announced that the Food and Drug Administration (FDA) has accepted for review the Abbreviated New Drug Application (ANDA) for Doxorubicin Hydrochloride (HCI) Liposome Injection, the generic version of Janssen's Doxil.
A manufacturing disruption in 2011 had placed Doxil on the FDA drug shortage list. During that time, a generic version of Sun Pharma's Doxorubicin HCl Liposome Injection was approved. Merrimack's (under partnership with Actavis) Doxorubicin HCI Liposome Injection will share the market if approved by the FDA.
Doxorubicin HCl Liposome Injection is approved to treat ovarian cancer refractory to platinum-based chemotherapy, AIDS-related Kaposi's sarcoma refractory to combination chemotherapy, and multiple myeloma, in combination with bortezomib, in patients not previously treated with bortezomib and who have received at least one prior therapy.
Doxorubicin HCl Liposome Injection is available as a 2mg/mL strength disperson for IV infusion after dilution.
For more information call (844) 441-6225 or visit Merrimackpharma.com.