Doxil — The First FDA-Approved Nano-Drug: From an Idea to a Product - Harnessing Biomaterials in Nanomedicine: Preparation, Toxicity, and Applications - page 336

Doxil success. It demonstrates that such a development requires a
multidisciplinary approach and is highly dependent on understanding
and optimal use of physicochemical and nano-technology principles.
Doxil, which is considered today the gold standard in liposome-based
drug delivery systems, has opened the road to the development of
other anticancer and anti-inflammatory nano-drugs that make used
of the EPR eff ect and remote drug loading.
12.1 HistoricalPerspectives
I will never forget the cool, early morning (01:00 AM) in November
1995 when most of the Liposome Technology Inc. (LTI) employees
and I were waiting in the big, noisy storage area of LTI at 1050
Hamilton Court, Menlo Park, CA, with a lot of food, drinks, and many
discussions waiting nervously to see online the FDA's Oncologic Drug
Advisory Committee (ODAC) meeting in Washington, DC, at which
a recommendation to the FDA to approve or disapprove Doxil ® for
Kaposi's sarcoma indication should be given. ODAC's session started
at 08:00 AM Eastern time (05:00 CA time). The happy end of that
morning was that Doxil's approval was recommended. Doxil is
actually an abbreviation of the words “ DOX orubicin I n L iposomes.”
Doxil vials ((Figure 12.1) were distributed for clinical use by
Sequus Pharmaceuticals (previously LTI) as early as 1996.
Figure 12.1 Doxil vial as sold by Sequus Pharmaceuticals (1996). See also
Color Insert.