HHS-Licensed Products Approved by the FDA

 

Developed with Technologies from HHS Intramural Research Programs

Zinbryta
Monthly injectable for treating relapsing forms of multiple sclerosis in patients who failed to respond to two or more previous therapies.
Licensee: Biogen
FDA Approval: 27 May 2016
First Commercial U.S. Sale: 2016
Agency: NIH
License: Active
 
PREZCOBIX
For use in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults.
Licensee: Janssen Therapeutics
FDA Approval: 29 Jan 2015
First Commercial U.S. Sale: 2015
Agency: NIH
License: Active
 
Zilver® PTX® Drug-Eluting Peripheral Stent
This is the first drug-eluting stent approved to treat peripheral arterial disease in the superficial femoral artery. This device combines the mechanical support of stenting with the drug paclitaxel to reduce the risk of restenosis.
Licensee: Angiotech/Cook Medical
FDA Approval: 15 Nov 2012
First Commercial U.S. Sale: 2012
Agency: NIH
License: Active
 
Cervarix®
Cervarix® is a bivalent Human Papilloma Virus (HPV) vaccine that protects against infection by HPV16 and HPV18 viruses. Infections from these viruses have been etiologically linked to cervical cancer.
Licensee: MedImmune Inc./GlaxoSmithKline
FDA Approval: 16 Oct 2009
First Commercial U.S. Sale: 2009
Agency: NIH
License: Active
 
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
License: Active
 
Gardasil®
A new 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
License: Active
 
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
License: Active
 
Didanosine Delayed-Release Capsules
Generic equivalent for Videx® EC, a treatment of HIV infection with ddI. Selectively inhibits the replication of HIV by interfering with a critical element known as reverse transcriptase. Because of being better tolerated or having a different pattern of toxicity than other treatments, patients may find it useful in either individual or combination treatment therapy.
Licensee: Barr Laboratories
FDA Approval: 03 Dec 2004
First Commercial U.S. Sale: 2005
Agency: NIH
License: Inactive
 
TAXUS® Express2®  Monorail Paclitaxel-Eluting Coronary Stent System
Treatment of coronary artery disease by balloon angioplasty and placement of a stent is often followed by restenosis caused by cellular proliferation. The TAXUS® Express2® stent system contains two medical components: the Express2 coronary stent and paclitaxel contained in a polymer coating. NIH researchers discovered that the paclitaxel component inhibits cellular proliferation and subsequent restenosis thus leading to greatly improved medical outcomes.
Licensee: Angiotech/Boston Scientific
FDA Approval: 04 Mar 2004
First Commercial U.S. Sale: 2004
Agency: NIH
License: Active
 
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
License: Active
 
Zevalin®
A treatment for non-Hodgkin's lymphoma, which affects 50,000 Americans annually. A majority of these cases are low-grade lymphomas that do not respond to other treatments. Treatment with Zevalin®, which is simple and fast, and has less severe side effects, is especially suited for these patients. This drug combines the targeting power of monoclonal antibodies with the cell killing ability of radioactive atoms, and is the first radioimmunotherapy to be approved by the FDA.
Licensee: IDEC Pharmaceuticals
FDA Approval: 19 Feb 2002
First Commercial U.S. Sale: 2002
Agency: NIH
License: Inactive
 
Twinrix®
A vaccine formulation that combines both Hepatitis A and Hepatitis B. Combining the two vaccines, for two of the most common infectious diseases that represent serious public health problems, Twinrix® offers significant advantages such as increased convenience for patient and physician, fewer injections and greater compliance compared with two separate vaccines.
Licensee: GlaxoSmithKline
FDA Approval: 11 May 2001
First Commercial U.S. Sale: 2001
Agency: NIH
License: Inactive
 
Parvovirus B19 Enzyme Immunoassay
By detecting B19 virus IgM antibodies in human serum and plasma, this product should be helpful in diagnosing and managing parvovirus B19 infection, which can put pregnant women at serious risk of fetal loss. This is the first diagnostic test for parvovirus B19 infection approved by the FDA for U.S. use.
Licensee: MedImmune Inc./Biotrin International
FDA Approval: 06 Aug 1999
First Commercial U.S. Sale: 2001
Agency: NIH
License: Inactive
 
NeoTect®
A synthetic peptide radiopharmaceutical used for the diagnosis of lung cancer. The probe binds to somatostatin receptor-bearing masses in the lungs, and offers additional information to the physician. The procedure, being minimally invasive, carries much reduced risk compared to invasive procedures like biopsies. (Manufacturer has withdrawn the product from the market)
Licensee: Berlex Laboratories, formerly Diatide Inc.
FDA Approval: 03 Aug 1999
First Commercial U.S. Sale: 1999
Agency: NIH
License: Inactive
 
LYMErix
The world's first vaccine for the prevention of Lyme disease. Lyme disease is one of the fastest vector-borne diseases in the US. It can lead to severe and debilitating problems such as arthritis, heart abnormalities and Bell's palsy. (Manufacturer has withdrawn the product from the market)
Licensee: GlaxoSmithKline
FDA Approval: 21 Dec 1998
First Commercial U.S. Sale: 1999
Agency: NIH
License: Inactive
 
Thyrogen®
A recombinant form of human thyroid stimulating hormone (TSH) for use in follow-up screening of patients who have been treated for thyroid cancer. Thyrogen® permits these patients to avoid the debilitating effects of thyroid hormone withdrawal while undergoing standard diagnostic procedures such as serum thyroglobulin testing and radioiodine imaging.
Licensee: Genzyme Corp.
FDA Approval: 30 Nov 1998
First Commercial U.S. Sale: 1998
Agency: NIH
License: Active
 
AcuTect®
A synthetic peptide radiopharmaceutical used for the detection of acute deep venous thrombosis (DVT). DVT affects an estimated 5 million individuals in the U.S. each year and is the most common source of pulmonary embolism. AcuTect® is the first in-vivo imaging agent to target acute DVT in the lower extremities.
Licensee: Berlex Laboratories, formerly Diatide Inc.
FDA Approval: 14 Sep 1998
First Commercial U.S. Sale: 1998
Agency: NIH
License: Inactive
 
RotaShield®
A live oral vaccine for the prevention of rotavirus gastroenteritis in infants. Rotavirus is the single most common cause of epidemic severe acute gastroenteritis (diarrhea and vomiting) in infants and children from both developed and developing countries. RotoShield® is the first rotavirus vaccine approved for use in humans. (Manufacturer has withdrawn the product from the market)
Licensee: Wyeth Laboratories Inc.
FDA Approval: 31 Aug 1998
First Commercial U.S. Sale: 1998
Agency: NIH
License: Inactive
 
Vitravene®
A phosphorothioate oligonucleotide that inhibits cytomeglovirus (CMV) infections in the eye. Such infections commonly occur in immunocompromised patients with resultant damage to the retina. Vitravene® is the first antisense therapeutic approved for use in humans.
Licensee: Isis Pharmaceuticals Inc.
FDA Approval: 26 Aug 1998
First Commercial U.S. Sale: 1998
Agency: NIH
License: Inactive
 
Certiva®
A combined diphtheria, tetanus and acellular pertussis vaccine for use in infants and children. A special process that reduces local and systemic adverse events commonly associated with traditional whole-cell DPT vaccine administration has detoxified the acellular pertussis component of this vaccine. Certiva® is the first pediatric vaccine introduced into the U.S. market by a new independent vaccine producer in over ten years. (Manufacturer has withdrawn the product from the market)
Licensee: Baxter Pharmaceuticals, formerly North American Vaccine, Inc.
FDA Approval: 29 Jul 1998
First Commercial U.S. Sale: 1998
Agency: NIH
License: Inactive
 
Synagis®
A monoclonal antibody used for the prevention and treatment of serious lower respiratory tract disease by respiratory syncytial virus (RSV). RSV is the most common cause of pneumonia and bronchiolitis in infancy and early childhood. Synagis is the world's first monoclonal antibody licensed by the FDA for any infectious disease.
Licensee: MedImmune Inc.
FDA Approval: 19 Jun 1998
First Commercial U.S. Sale: 1998
Agency: NIH
License: Active
 
ZENAPAX®
A humanized monoclonal antibody used for the prevention of acute kidney transplant rejection. This recombinantly produced antibody achieves its immunosuppressive properties by binding to the alpha (or Tac) subunit of human interleukin-2 (IL-2) receptor that is expressed on the surface of activated lymphocytes.
Licensee: Protein Design Laboratory/Hoffman-LaRoche
FDA Approval: 10 Dec 1997
First Commercial U.S. Sale: 1998
Agency: NIH
License: Inactive
 
SPORANOX® Oral Solution
Oral formulation of the anti-fungal agent itraconazole that is used for the treatment of painful and debilitating fungal infections of the esophagus and mouth, commonly called thrush. Itraconazole is solubilized for this application through coupling with hydroxy-propyl-cyclodextrin, a molecular inclusion complex.
Licensee: Janssen Pharmaceuticals
FDA Approval: 21 Feb 1997
First Commercial U.S. Sale: 1997
Agency: NIH
License: Active
 
Havrix®
A vaccine from the isolation of Hepatitis A virus strain HM-175. Hepatitis A is probably the most widespread of viral hepatitis diseases and is an endemic childhood disease in the underdeveloped countries of the world.
Licensee: GlaxoSmithKline
FDA Approval: 22 Feb 1995
First Commercial U.S. Sale: 1997
Agency: NIH
License: Inactive
 
NeuTrexin®
A treatment using trimetrexate as an anti-parasitic agent for infection. Infections due to Toxoplasma gondii and Pneumocystis carinii, as seen in AIDS patients are extremely refractory to standard therapy can be effectively treated by administering this drug.
Licensee: MedImmune Inc.
FDA Approval: 17 Dec 1993
First Commercial U.S. Sale: 1994
Agency: NIH
License: Inactive
 
Taxol®
An improved method for administering Taxol® (paclitaxel) has significantly improved the treatment of cancerous tumors, particularly advanced stage epithelial ovarian and breast cancers. Paclitaxel is a compound derived from the bark of the Western Yew tree.
Licensee: Bristol-Myers Squibb
FDA Approval: 29 Dec 1992
First Commercial U.S. Sale: 1996
Agency: NIH
License: Inactive
 
Hivid®
A treatment of HIV infection with ddC. Inhibits the replication of HIV by interfering with the critical enzyme reverse transcriptase. Patients find it useful in either individual or combination treatment therapy.
Licensee: Hoffmann-LaRoche
FDA Approval: 19 Jun 1992
First Commercial U.S. Sale: 1992
Agency: NIH
License: Inactive
 
Videx®
A treatment of HIV infection with ddI. Selectively inhibits the replication of HIV by interfering with a critical element known as reverse transcriptase. Because of being better tolerated or having a different pattern of toxicity than other treatments, patients may find it useful in either individual or combination treatment therapy.
Licensee: Bristol-Myers Squibb
FDA Approval: 09 Oct 1991
First Commercial U.S. Sale: 1991
Agency: NIH
License: Inactive
 
Fludara®
A DNA polymerase inhibitor (fludarabine) that has been shown to have potent activity in the treatment of B-cell leukemia. This compound is a cancer chemotherapeutic drug, 2-F-araA.
Licensee: Berlex Laboratories
FDA Approval: 18 Apr 1991
First Commercial U.S. Sale: 1991
Agency: NIH
License: Inactive