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New Drug and Biological Product Approvals, 2003

Kate Traynor

About 70 drug products, including 21 new molecular entities and 9 biological products, won FDA marketing approval last year-a decline from 2002, when 80 drugs and 8 biologicals were approved or licensed.

A synopsis of noteworthy drug approval news appears below. Indications for new molecular entities and new biologicals approved in 2003 are provided in the table below.

On the battlefield. The year 2003 saw the arrival of three products designed to protect against agents that might be released during wartime or as an act of terrorism. FDA in February granted regulatory clearance for pyridostigmine bromide oral tablets, developed by the U.S. Army Medical Research and Materiel Command, to protect soldiers from the effects of exposure to the nerve gas soman. The preexposure therapy was approved on the basis of the so-called animal efficacy rule, which FDA adopted in 2002 to speed the approval of agents that cannot be ethically tested in humans but could provide protection from the effects of weapons used in a biological or chemical attack.

Another new weapon in the U.S. military's protective arsenal is Reactive Skin Decontamination Lotion, by O'Dell Engineering Ltd. of Canada, which earned regulatory approval in March as a topical liquid for the removal or neutralization of chemical warfare agents and the T-2 fungal toxin, a potentially lethal mycotoxin.

FDA in October approved the marketing of Prussian blue oral capsules, or Radiogardase, for the treatment of radiation contamination caused by exposure to cesium-137 or thallium. HEYL Chemisch-Pharmazeutische Fabrik GmbH & Co. KG of Berlin, Germany, submitted a new drug application for the product after FDA announced in January that the agency considers Prussian blue a safe and effective treatment for exposure to radioactive cesium or radioactive or nonradioactive thallium.

In a similar announcement, FDA stated in September that pentetate calcium trisodium and pentetate zinc trisodium are safe and effective for the treatment of certain radioactive exposures. The agency is soliciting new drug applications for these treatments but has not yet approved any products related to the solicitation.

New options for cancer. Two products classified as new molecular entities won FDA marketing approval for cancer treatment in 2003, and a third product was approved as adjunctive therapy.

The tyrosine kinase blocker gefitinib, marketed by AstraZeneca as Iressa, in May became the first drug in its class to win FDA marketing approval. The product is indicated as a second-line agent for the treatment of advanced non-small-cell lung cancer.

Also approved in May was Velcade, Millennium Pharmaceuticals' bortezomib product, for the treatment of multiple myeloma. Bortezomib is a proteasome inhibitor, the first drug in the class to receive FDA marketing clearance.

Merck's aprepitant product, Emend, in March became the first antinausea agent to earn FDA marketing approval for the prevention of delayed nausea and vomiting associated with chemotherapy. The product was approved only for use in combination with other antiemetics and antinausea drugs.

Fighting infection. FDA in March approved the marketing of Fuzeon, or enfuvirtide, an HIV-1 fusion inhibitor and the first drug in its class on the market. Enfuvirtide inhibits the virus from fusing with and entering certain immune cells.

Also in March, FDA granted marketing approval for FluMist, MedImmune's live attenuated intranasal influenza vaccine for use in healthy children and adolescents age 5 years or older and healthy adults. Buyer uptake of the product was slower than the manufacturer initially predicted but received a boost after injectable influenza vaccines became scarce during the current influenza epidemic.

Hormone therapy and contraception. FDA and makers of hormone-replacement therapy (HRT) products continued to react to the finding, in 2002, that estrogen-progestin HRT is riskier than was previously supposed. FDA in January required new labeling for all estrogen and estrogen-progestin products to warn of the cardiovascular and cancer risks associated with the therapy. Women are now advised to use HRT for the short-term treatment of moderate to severe symptoms associated with menopause and, in some cases, to prevent osteoporosis.

Faced with the declining use of traditional HRT, Wyeth last year won FDA approval to market lower-dose versions of the company's conjugated estrogens and conjugated estrogens-medroxyprogesterone products, Premarin and Prempro, available as oral tablets.

Two new hormonal therapies with novel delivery systems made their debut last year for the treatment of menopausal symptoms: Estrasorb, an estradiol topical emulsion made by Novavax, received FDA marketing approval in October for the treatment of hot flashes and night sweats associated with menopause; and Climara Pro, an estradiol-levonorgestrel transdermal patch made by Berlex, was approved in November.

Premenopausal women were presented with a new option for contraception in September when FDA granted marketing approval for Barr Laboratories's Seasonale ethinyl estradiol-levonorgestrel contraceptive tablets. Seasonale extended-cycle contraceptive tablets are taken daily for 84 consecutive days followed by 7 placebo tablets, resulting in four menstrual cycles per year.

The first chewable contraceptive tablet, Ovcon 35, with ethinyl estradiol and norethindrone, received marketing clearance in November.

Erectile dysfunction. Men's health received attention last year with the marketing approval of two erectile dysfunction remedies-Bayer's vardenafil hydrochloride product, Levitra, which was approved in August, and Lilly ICOS's tadalafil product, Cialis, approved in November. These products compete with Viagra, Pfizer's sildenafil citrate remedy for erectile dysfunction, which was approved in 2002.

2003 Drug Approvals

New molecular entities and new biologicals, 2003a

Abarelix for injectable suspension (Plenaxis, Praecis), for the palliative treatment of men with advanced symptomatic prostate cancer, in whom luteinizing hormone-releasing hormone agonist therapy is not appropriate and who refuse surgical castration, and have one or more of the following: risk of neurologic compromise due to metastases, ureteral or bladder outlet obstruction due to local encroachment or metastatic disease, or severe bone pain from skeletal metastases despite narcotic analgesia
Alfuzosin hydrochloride extended release oral tablets (Uroxatral, Sanofi-Synthelabo), for the treatment of the signs and symptoms of benign prostatic hyperplasia
Alpha1-proteinase inhibitor, human, for injection (Zemaira, Aventis), for chronic augmentation and maintenance therapy in adults with alpha-1-antitrypsin deficiency and evidence of emphysema
Antihemophilic factor, recombinant, plasma/albumin-free method, for injection (Advate, Baxter), for the prevention and control of bleeding episodes and for the perioperative management of patients with hemophilia A
Aprepitant oral capsules (Emend, Merck), for use, in combination with other antiemetic agents, to prevent acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy, including high-dose cisplatin
Atazanavir sulfate oral capsules (Reyataz, Bristol-Myers Squibb), for the treatment of HIV-1 infection, in combination with other antiretroviral agents
Bortezomib for injection (Velcade, Millennium), for the treatment of multiple myeloma in patients who have received at least two prior therapies and have demonstrated disease progression on the last therapy
Botulism immune globulin, i.v., human (BabyBIG, California Department of Health Services), for the treatment of infant botulism caused by type A or type B Clostridium botulinum
Daptomycin i.v. injection (Cubicin, Cubist), for the treatment of complicated skin and skin structure infections caused by susceptible strains of the gram-positive microorganisms Staphylococcus aureus (including methicillin-resistant strains), Streptococcus pyogenes, S. agalactiae, S. dysgalactiae subsp. equisimilis and Enterococcus faecalis (vancomycin-susceptible strains only)
Emtricitabine oral capsules (Emtriva, Gilead), for the treatment of HIV-1 infection in adults, in combination with other antiretroviral agents
Enfuvirtide injection (Fuzeon, Roche), for the treatment of HIV-1 infection, in combination with other antiretroviral agents, in patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy
Epinastine hydrochloride ophthalmic solution (Elestat, Allergan), for the prevention of itching associated with allergic conjunctivitis
Fibrin sealant, human (Crosseal, OMRIX Biopharmaceuticals), as an adjunct to hemostasis in patients undergoing liver surgery, when control of bleeding by conventional surgical techniques is ineffective or impractical
Gefitinib oral tablets (Iressa, AstraZeneca), for the treatment of locally advanced or metastatic non-small-cell lung cancer after failure of both platinum-based and docetaxel chemotherapies
Gemifloxacin mesylate oral tablets (Factive, LG Life Sciences), for the treatment of mild to moderate community-acquired pneumonia caused by multidrug-resistant Streptococcus pneumoniae and other susceptible pathogens and for the treatment of acute bacterial exacerbations of chronic bronchitis
Ibandronate sodium oral tablets (Boniva, Roche), for the prevention and treatment of osteoporosis in postmenopausal women
Immune globulin, i.v., human (Flebogamma, Instituto Grifols), for replacement therapy in primary, or inherited, humoral immunodeficiency disorders
Immune globulin, i.v., human (Gamunex, Bayer), for the treatment of primary humoral immunodeficiency and idiopathic thrombocytopenic purpura
Influenza virus vaccine, live, intranasal (FluMist, MedImmune), for active immunization against influenza A and B viruses in healthy children and adolescents age 5-17 years of age and healthy adults age 18-49 years
Memantine hydrochloride oral tablets (Namenda, Forest), for the treatment of moderate to severe dementia of the Alzheimer's type
Miglustat oral capsules (Zavesca, Actelion), for the treatment of mild to moderate type 1 Gaucher's disease in adults
Palonosetron hydrochloride injection (Aloxi, Helsinn Healthcare), for the prevention of acute nausea and vomiting associated with initial and repeat courses of moderately and highly emetogenic cancer chemotherapy and for prevention of delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy
Pegvisomant for injection (Somavert, Pharmacia), for the treatment of acromegaly in patients who have not responded adequately to surgery, radiation, or other medical therapies or for whom these therapies are not appropriate
Prussian blue oral capsules, insoluble (Radiogardase, Heyl Chemisch-pharmazeutische Fabrik GmbH), for the treatment of patients with known or suspected internal contamination with radioactive cesium or radioactive or nonradioactive thallium to increase their rates of elimination
Rosuvastatin calcium oral tablets (Crestor, AstraZeneca), as an adjunct to diet for the improvement of lipid profiles in adults with primary hypercholesterolemia and mixed dyslipidemia and as an adjunct to diet for patients with an elevated level of serum triglycerides
Sertaconazole nitrate topical cream (Ertaczo, Mylan), for the treatment of interdigital tinea pedis caused by Trichophyton rubrum, T. mentagrophytes, and Epidermophyton floccosum in immunocompetent patients 12 years of age or older
Tadalafil oral tablets (Cialis, Lilly), for the treatment of erectile dysfunction in men
Tetanus and diphtheria toxoids adsorbed (Tetanus and diphtheria toxoids adsorbed, Aventis), for primary and booster immunization of persons 7-59 years of age against tetanus and diphtheria
Tositumomab and iodine 131 tositumomab (Bexxar, Corixa), for the treatment of patients with CD20-positive, follicular, non-Hodgkin's lymphoma, with and without transformation, whose disease is refractory to rituximab and has relapsed following chemotherapy
Vardenafil hydrochloride oral tablets (Levitra, Bayer), for the treatment of erectile dysfunction in men

aFrom information available on FDA's Web site, January 2004.