Archived HHS-Licensed Products Approved by the FDA

 

Archive of Vaccines and Therapeutics Developed with Technologies Licensed from HHS Intramural Research Programs

Dengvaxia®

Dengvaxia® (Dengue Tetravalent Vaccine, Live) is a vaccine indicated for the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3, and 4. Dengvaxia is approved for use in individuals 9 through 16 years of age with laboratory-confirmed previous dengue infection and living in endemic areas.

 

Licensee:

Sanofi Pasteur

FDA Approval:

May 1, 2019

First Commercial U.S. Sale:

2019

Agency:

NIH

U.S. Patents:

6,184,024; 6,676,936
 

Gardasil 9®

A new vaccine to protect against human papilloma virus (HPV) for use in males and females aged 9 to 45. Gardasil 9 prevents certain cancers and diseases caused by the nine HPV types covered by the vaccine.
 

Licensee:

Merck & Co., Inc.

FDA Approval:

October 5, 2018

First Commercial U.S. Sale:

2019

Agency:

NIH

U.S. Patents:

5,437,951; 5,618,536; 5,709,996; 5,716,620; 5,744,142; 5,756,284; 5,855,841; 5,871,998; 5,985,610; 7,220,419; 7,361,356; 7,462,356; 7,691,386
 

Symtuza®

Symtuza is a four-drug combination of darunavir (DRV), a human immunodeficiency virus (HIV-1) protease inhibitor, cobicistat (COBI), a CYP3A inhibitor, and emtricitabine (FTC) and tenofovir alafenamide (TAF), both HIV-1 nucleoside analog reverse transcriptase inhibitors, and is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients.

Licensee:

Janssen Therapeutics

FDA Approval:

July 17, 2018

First Commercial U.S. Sale:

2019

Agency:

NIH

U.S. Patents:

7,470,506; 8,597,876; 9,889,115
   

Zinbryta®

Monthly injectable interleukin-2 receptor blocking antibody for treating relapsing forms of multiple sclerosis in patients who failed to respond to two or more previous therapies.

Licensee:

Biogen

FDA Approval:

May 27, 2016

First Commercial U.S. Sale:

2016

Agency:

NIH

U.S. Patents:

7,575,742; 8,298,525; 8,636,997
 

Prezcobix®

Prezcobix is a two-drug combination of darunavir, a human immunodeficiency virus (HIV-1) protease inhibitor, and cobicistat, a CYP3A inhibitor, and is indicated for the treatment of HIV-1 infection in treatment-naïve and treatment-experienced.

Licensee:

Janssen Therapeutics

FDA Approval:

January 25, 2015

First Commercial U.S. Sale:

2015

Agency:

NIH

U.S. Patents:

7,470,506; 8,597,876; 9,889,115
 

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:

November 15, 2012

First Commercial U.S. Sale:

2012

Agency:

NIH

U.S. Patents:

5,616,608; 6,403,635; 6,429,232; 6,500,859
 

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:

October 16, 2009

First Commercial U.S. Sale:

2009

Agency:

NIH

U.S. Patents:

5,437,951; 5,618,536; 5,709,996; 5,716,620; 5,744,142; 5,756,284; 5,855,841; 5,871,998; 5,985,610; 7,220,419; 7,361,356; 7,462,356; 7,691,386
 

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:

June 23, 2006

First Commercial U.S. Sale:

2006

Agency:

NIH

U.S. Patents:

7,470,506; 8,597,876; 9,889,115
 

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:

June 8, 2006

First Commercial U.S. Sale:

2006

Agency:

NIH

U.S. Patents:

5,437,951; 5,618,536; 5,709,996; 5,716,620; 5,744,142; 5,756,284; 5,855,841; 5,871,998; 5,985,610; 7,220,419; 7,361,356; 7,462,356; 7,691,386
 

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:

December 15, 2004

First Commercial U.S. Sale:

2005

Agency:

NIH

U.S. Patents:

5,654,405; 5,665,870; 5,707,805; 5,731,170; 5,741,642; 6,420,531; 6,709,842; 6,833,132; 7,026,291
 

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:

December 3, 2004

First Commercial U.S. Sale:

2005

Agency:

NIH

U.S. Patents:

4,861,759; 5,026,687; 5,254,539; 5,376,642; 5,616,566
 

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:

March 4, 2004

First Commercial U.S. Sale:

2004

Agency:

NIH

U.S. Patents:

5,616,608; 6,403,635; 6,429,232; 6,500,859
 

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:

February 19, 2002

First Commercial U.S. Sale:

2002

Agency:

NIH

U.S. Patents:

4,831,175; 5,099,069; 5,246,692
 

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:

May 11, 2001

First Commercial U.S. Sale:

2001

Agency:

NIH

U.S. Patents:

4,532,215; 4,620,978; 4,636,469; 6,113,912; 6,180,110; 6,423,318; 6,680,060
 

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. 

Licensee:

Berlex Laboratories, formerly Diatide Inc.

FDA Approval:

August 3, 1999

First Commercial U.S. Sale:

1999

Agency:

NIH

U.S. Patents:

5,066,716
 

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. 

Licensee:

GlaxoSmithKline

FDA Approval:

December 21, 1998

First Commercial U.S. Sale:

1999

Agency:

NIH

U.S. Patents:

4,578,355; 4,925,799
 

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:

November 30, 1998

First Commercial U.S. Sale:

1998

Agency:

NIH

U.S. Patents:

6,117,991; 6,284,491
 

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:

September 14, 1998

First Commercial U.S. Sale:

1998

Agency:

NIH

U.S. Patents:

5,066,716
 

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. 

Licensee:

Wyeth Laboratories Inc.

FDA Approval:

August 31, 1998

First Commercial U.S. Sale:

1998

Agency:

NIH

U.S. Patents:

4,571,385; 4,704,275; 4,751,080
 

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:

August 26, 1998

First Commercial U.S. Sale:

1998

Agency:

NIH and FDA

U.S. Patents:

5,003,097; 5,264,423; 5,276,019; 5,286,717
 

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® was the first pediatric vaccine introduced into the U.S. market by a new independent vaccine producer in over ten years. 

Licensee:

Baxter Pharmaceuticals, formerly North American Vaccine, Inc.

FDA Approval:

July 29, 1998

First Commercial U.S. Sale:

1998

Agency:

NIH

U.S. Patents:

4,762,710; 5,338,670
 

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:

June 19, 1998

First Commercial U.S. Sale:

1998

Agency:

NIH

U.S. Patents:

Biological Material License
 

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:

December 10, 1997

First Commercial U.S. Sale:

1998

Agency:

NIH

U.S. Patents:

7,094,404
 

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:

February 21, 1997

First Commercial U.S. Sale:

1997

Agency:

NIH

U.S. Patents:

4,727,064; 5,096,893
 

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:

February 22, 1995

First Commercial U.S. Sale:

1997

Agency:

NIH

U.S. Patents:

4,727,064; 5,096,893
 

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:

December 17, 1993

First Commercial U.S. Sale:

1994

Agency:

NIH

U.S. Patents:

4,694,007
   

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:

December 29, 1992

First Commercial U.S. Sale:

1996

Agency:

NIH

U.S. Patents:

5,496,804; 5,496,846; 6,150,398
 

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:

June 19, 1992

First Commercial U.S. Sale:

1992

Agency:

NIH

U.S. Patents:

4,879,277
 

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:

October 9, 1991

First Commercial U.S. Sale:

1991

Agency:

NIH

U.S. Patents:

4,861,759; 5,026,687; 5,254,539; 5,376,642; 5,616,566
 

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:

April 18, 1991

First Commercial U.S. Sale:

1991

Agency:

NIH

U.S. Patents:

4,188,378; 4,210,745; 4,357,324
 

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