Lessons Learned from Pharmaceutical Nanomaterials - Safety of Nanomaterials along Their Lifecycle - page 124

TABLE 6.1
Approved Examples of Nanomedicine Products

Delivery
Route

FDA Approval
Date Brand Name Nanoparticle Drug Component Company FDA Approved Indication(s)

Abraxane ® Paclitaxel bound albumin NP IV Abraxis BioScience, AstraZeneca Various cancers Jan 2005

AmBiSome ® Amphotericin B liposomes IV Gilead Sciences Fungal infections, leishmaniasis Aug 1997

Doxil/Caelyx ® PEGylated doxorubicin*HCl

liposomes

IV OrthoBiotech Schering-Plough Metastatic ovarian cancer and AIDS

related Kaposi's sarcoma

Nov 1995

DaunoXome ® Encapsulated daunorubicin citrate

liposomes

IV Gilead Sciences Advanced HIV related Kaposi's

sarcoma

Apr 1996

Emend ® Nanocrystal aprepitant Oral Merck, Elan Nausea in chemotherapy patients Mar 2003

Rapamune ® Nanocrystal sirolimus Oral Wyeth, Elan Immunosuppressant for kidney

transplantation

Sep 1999

TriCor ® Nanocrystal fenoibrate Oral Abbott, Elan Primary hypercholesterolemia,

mixed lipidemia, and
hypertriglyceridemia

Nov 2004

Estrasorb ® Estradiol hemihydrate micellar NP

(emulsion)

Trans-dermal Novavax Reduction of vasomotor symptoms,

such as hot lushes and night
sweats in menopausal women

Oct 2003

Elestrin ® Estradiol gel (0.06%) incorpor.

calcium phosphate NP

Trans-dermal BioSanté Treatment of moderate to severe hot

lushes in menopausal women

Dec 2006

Source: Bawa, R., Touch Brieings, 2009, 6:122-127; and Möschwitzer, J.P., Int J Pharm, 2013, 453(1):142-156.

Note : Drug products shown in bold are explained in the text in more detail.