FDA Approves 16 New Biotech Products, Eight New Indications in 2001

Washington, D.C. (February 4, 2002) – The FDA approved 16 new biotechnology-based medicines and vaccines in 2001, as well as eight new indications for previously approved biotech products, according to an analysis by the Biotechnology Industry Organization (BIO). The new products include treatments for leukemia, congestive heart failure, rheumatoid arthritis and life-threatening sepsis, as well as a new combination vaccine for hepatitis A and B.

"Even though the number of approvals declined from 2000’s record of 32, we are pleased that the past year has brought important new additions to the pharmacopeia that will save and enhance lives," said Carl B. Feldbaum, president of BIO. "More than half of the 133 biotechnology medications available today have been approved in the last five years, and another 350 products are in late-stage development. That’s a consistent record of new therapeutic development from biotechnology, and more much-needed therapies are coming.

"One factor in this increase has been the positive outcome of the Prescription Drug User Fee Act, which is up for renewal this year. The law has led to reduced review and approval times. The prospect of further refinement in the law’s performance goals can only have a salutary effect on the drug approval process. That means, simply, more patients will get new drugs faster," Feldbaum added.

BIO represents more than 1,000 biotechnology companies, academic institutions, state biotechnology centers and related organizations in all 50 states and 33 other nations. BIO members are involved in the research and development of health-care, agricultural, industrial and environmental biotechnology products.

FDA Approvals, 2001

New Products*

Product Company Indication Approval date
(darbepoetin alfa;recombinant erythropoiesis-stimulating protein)
Amgen Anemia associated with chronic renal failure September
(alemtuzumab; recombinant monoclonal antibody against CD52 glycoprotein)
Ilex Oncology Inc., Millennium Pharmceuticals Inc. and Berlex Laboratories Inc. B-cell chronic lymphocytic leukemia in patients who have been treated with alkylating agents and who have failed fludarabine therapy May
(human-based, tissue-engineered living dermal substitute)
Advanced Tissue Sciences Inc. and Smith & Nephew plc Diabetic foot ulcers September
(digoxin immune fab [ovine])
Protherics plc Digoxin toxicity September
(dexmethylphenidate hydrochloride; refined version of methylphenidate containing only the active isomer)
Celgene Corp. and Novartis Pharmaceuticals Corp. Attention deficit hyperactivity disorder November
(frovatriptan succinate)
Vernalis Group plc and Elan Corp. plc Migraine November
(imatinib mesylate)
Novartis Pharmaceuticals Corp Chronic myeloid leukemia in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy May
(anakinra; recombinant form of non-glycosylated human interleukin-1 receptor antagonist)
Amgen Moderately to severely active rheumatoid arthritis in adult patients who have failed disease-modifying anti-rheumatic drugs November
Metadate® CD
(bi-phasic release formulation of methylphenidate)
Celltech Pharmaceuticals Inc. Attention deficit hyperactivity disorder April
(nesiritide; recombinant form of human B-type natriuretic peptide)
Scios Inc. Acutely decompensated congestive heart failure with shortness of breath at rest or with minimal activity August
(composite cultured skin; bi-layered cellular matrix)
Ortec International Inc. For patients with recessive dystrophic epidemolysis bullosa undergoing hand reconstruction surgery February
(pegylated version of recombinant interfreron alfa-2b)
Enzon Inc. and Schering-Plough Corp. Monotherapy for chronic hepatitis C January
Actelion Ltd. Pulmonary arterial hypertension with WHO Class III or IV symptoms November
(hepatitis A inactivated and hepatitis B [recombinant] vaccine)
SmithKline Beecham Biologicals (unit of GlaxoSmith-Kline) Immunization against hepatitis A and B viruses May
(tenofovir disoproxil fumarate)
Gilead Sciences For use in combination with other antiretroviral agents for treatment of HIV-1 infection October
(drotrecogin alfa activated; recombinant form of human Activated Protein C)
Eli Lilly and Co. Severe, life-threatening sepsis November

New Indications for Previously Approved Products*

Product Company Indication Approval date
Cathflo™ Activase®
(alteplase; recombinant tissue plasminogen activator)
Genentech Inc. Dissolution of clots in central venous access devices September
(recombinant form of human somatropin)
Pharmacia Long-term treatment of growth failure in children born small for gestational age who fail to catch up by age 2 July
Therapeutics Inc.
Acute coronary syndrome, including both patients managed medically and those undergoing percutaneous coronary intervention June
(insulin aspart; recombinant)
Novo Nordisk For pump therapy in diabetes December
(composite cultured skin; bi-layered cellular matrix)
Ortec International Inc. Treatment of donor site wounds in burn victims August
(pegylated version of recombinant interferon alfa-2b)
Enzon Inc. and Schering-Plough Combination therapy with Rebetol for treatment of hepatitis C in patients with compensated liver disease August
(basiliximab; recombinant monoclonal antibody that binds the interleukin-2 receptor-alpha chain)
Pharmaceutical Corp.
Prevention of rejection in combination with triple immunosuppressive therapy in renal transplant; use in pediatric renal transplant; and use of IV bolus injection March
(verteporfin for injection)
PhotoTherapeutics Inc. and Novartis Ophthalmics
Predominantly classic subfoveal choroidal neovascularization due to pathologic myopia (severe near-sightedness) August

* Note: This list includes novel biologics developed by biotechnology companies and pharmaceutical companies, as well as small-molecule products developed by biotechnology companies, and other selected small-molecule or tissue-engineered products. For a complete listing of 2001 FDA approvals, visit the agency's Web site at