HHS-Licensed Products Approved by the FDA

 

Developed with Technologies from HHS Intramural Research Programs

 

Lumoxiti

A prescription medicine used to treat adults with hairy cell leukemia.

Licensee:

AstraZeneca

FDA Approval:

13 September 2018

First Commercial U.S. Sale:

2019

Agency:

NIH

 

Spravato®

A nasal spray antidepressant for the treatment of treatment-resistant depression in adults.

Licensee:

Janssen Therapeutics

FDA Approval:

06 March 2019

First Commercial U.S. Sale:

2019

Agency:

NIH

 

Gardasil 9®

A new vaccine to protect against 9 types of HPV that causes cervical cancer, currently approved for use in females aged 9 to 26. 

Licensee:

Merck & Co. Inc.

FDA Approval:

05 October 2018

First Commercial U.S. Sale:

2019

Agency:

NIH

 

Gardasil®

Vaccine to protect against cervical cancer, currently approved for use in females aged 9 to 26. Gardasil® prevents infection against four forms of Human Papilloma Virus (HPV): HPV16, HPV18, HPV6, and HPV11.

Licensee:

Merck & Co. Inc.

FDA Approval:

08 Jun 2006

First Commercial U.S. Sale:

2006

Agency:

NIH

 

Prezista®

A novel protease inhibitor for the treatment of HIV-1 in patients who are non-responsive to existing antiretroviral therapies. Prezista® is approved for use in combination with low-dose administration of ritonavir, which helps decrease the breakdown of Prezista® in the body, thereby enhancing drug efficacy.

Licensee:

Tibotec Pharmaceuticals Ltd.

FDA Approval:

23 Jun 2006

First Commercial U.S. Sale:

2006

Agency:

NIH

 

Kepivance®

Kepivance® (palifermin) is a human keratinocyte growth factor protein produced using recombinant DNA technology. It is used to decrease the incidence and duration of severe mouth sores in patients with hematologic cancers who receive myelotoxic therapy. In such a therapy, the patients' myeloid cells are first destroyed by chemotherapy alone or in combination with radiation, and then reconstituted with a bone marrow transplant. Kepivance® is the first and only therapy to treat the severe mouth sores that afflict these patients as a painful and unavoidable side effect of the treatment.

Licensee:

Amgen Inc.

FDA Approval:

15 Dec 2004

First Commercial U.S. Sale:

2005

Agency:

NIH

 

Velcade®

A treatment for multiple myeloma that works by specifically inhibiting an enzyme complex known as the proteosome. Under an accelerated approval program, the FDA has allowed the use of Velcade® in patients who have failed two prior therapies. The selectivity and manageable side-effect profile of this boronic dipeptide compound makes it an exciting new cancer drug. NIH researchers made a critical contribution by developing stable, pharmaceutically acceptable compositions of these important compounds. Indeed, as the first proteosome inhibitor to be approved by the FDA, Velcade® opens the door for a new class of useful drugs.

Licensee:

Millennium Pharmaceuticals

FDA Approval:

13 May 2003

First Commercial U.S. Sale:

2003

Agency:

NIH

 

Archive of Products Previously Developed Using HHS Technologies