FDA acts to bolster supply of critically needed cancer drugs;
announcements build on President Obama’s Executive Order
Under FDA’s exercise of enforcement discretion
the chemotherapeutic drug Lipodox will be imported
as an alternative to Doxil. Doxil is used in
multiple treatment regimens, including treatment of
ovarian cancer after failure of platinum-based
chemotherapy. The drug is also indicated for use in
AIDS-related Kaposi’s sarcoma and multiple myeloma.
FDA anticipates that the incoming supply of Lipodox
will be able to fully meet patient needs.
FDA’s exercise of enforcement discretion for Lipodox
is a temporary, limited arrangement specific to Sun
Pharma Global FZE and its authorized distributor,
Caraco Pharmaceutical Laboratories Ltd.
Temporary importation of unapproved foreign drugs is
considered in rare cases when there is a shortage of
an approved drug that is critical to patients and
the shortage cannot be resolved in a timely fashion
with FDA-approved drugs.
When a company is identified that is willing and
able to import the needed drug product, FDA
evaluates the foreign-approved drug to ensure that
it is of adequate quality and that the drug does not
pose significant risks for US patients. Only after
successful evaluation of these factors does FDA
exercise its enforcement discretion for the
temporary importation of an overseas drug into the
With regard to methotrexate, a drug that is needed
for the treatment of many forms of cancer and other
serious diseases, FDA has successfully engaged many
firms to assist in maintaining supplies to meet all
patient needs. Preservative-free methotrexate is
needed for the intrathecal (injection into the fluid
surrounding the brain and spinal cord) treatment of
children with acute lymphocytic leukemia (ALL) and
for the high-dose therapy of osteosarcoma.
First, FDA has prioritized review of and approved a
preservative-free methotrexate generic drug
manufactured by APP Pharmaceuticals and expects that
product to become available in March and continue
indefinitely. Second, Hospira expedited release of
additional supplies, resulting in 31,000 vials of
new product – enough for more than one month’s worth
of demand – being shipped to hundreds of U.S.
hospitals and treatment centers today. FDA is
actively working with other manufacturers of
methotrexate who have also stepped up to increase
production in order to meet patient needs, including
Mylan and Sandoz Pharmaceuticals.