FDA: Liposomal Doxorubicin HCl Supply Update

Sun Pharma Global has confirmed to the FDA that there are sufficient supplies of its Doxorubicin HCl Liposome Injection, the generic version of Janssen’s Doxil, to provide for the U.S. market.

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On September 25, 2013, Janssen notified healthcare professionals of an interruption in the supply of Doxil (doxorubicin HCl [liposomal]) 2mg/mL (10mL vial) due to manufacturing issues at Ben Venue Laboratories. Then on October 3, 2013, Ben Venue Laboratories announced their plans to cease all manufacturing by the end of the year.

Sun Pharma Global’s Doxorubicin HCl Liposome Injection is indicated for the treatment of ovarian cancer with disease progression after platinum-based chemotherapy and for AIDS-related Kaposi’s sarcoma in patients after failure of prior systemic chemotherapy or intolerance to such therapy.

Doxil is also indicated for multiple myeloma in combination with bortezomib in patients who have not previously received bortezomib and have received at least one prior therapy, however Sun Pharma Global’s product labeling does not include this indication.

Doxorubicin HCl Liposome Injection is available from Sun Pharma Global as a 2mg/mL strength in 10mL and 25mL vials.

For more information call (888) 835-2237 or visit SunPharma.com