* FDA approves Sun Pharma Global FZE's generic Doxil
* First generic version to be approved by FDA
* Approval expected to relieve shortages
By Toni Clarke
Feb 4 U.S. health regulators have approved a
generic version of the cancer drug Doxil in a move that could
ease a months-long shortage that has threatened the lives of
thousands of patients.
The U.S. Food and Drug Administration said on Monday it
approved a version of Doxil, known generically as doxorubicin
HCI liposome injection, that is made by Sun Pharma Global FZE, a
subsidiary of India's Sun Pharmaceutical Industries Ltd
. It will be available in 20 milligram and 50 milligram
Sun's product is the first generic version of Doxil, which
was approved in 1995 and is used to treat ovarian cancer,
AIDS-related Kaposi's sarcoma, and multiple myeloma. Doxil is
made by Johnson & Johnson.
Doxil fell into short supply after manufacturing problems at
an outside contract manufacturer, Ben Venue Laboratories Inc, a
unit of German drugmaker Boehringer Ingelheim, suspended
operations in November 2011 due to quality control problems.
Last February, the FDA allowed for the temporary importation
of Lipodox, which is made by Sun and contains the same active
ingredient as Doxil. The agency said it intends to continue
allowing the importation of Lipodox until Sun has made enough
generic Doxil to meet demand.
Late last month a federal judge approved a consent decree
under which Ben Venue must bring its Bedford, Ohio facility into
compliance with regulatory requirements or face fines and other
The FDA said the company had repeatedly violated good
manufacturing practices. Recent inspections found that poorly
maintained equipment deteriorated to the point that it shed
particles into injectable drugs, the FDA said.
President Barack Obama made drug shortages a national
priority with an executive order in October, 2011.