FDA Perspective

Significant FDA Approvals in 1999

Am Fam Physician. 2000 Apr 15;61(8):2531-2533.

During 1999, the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA) took 190 actions on original new drug applications. Of these actions, 83 were drug approvals that occurred in a median time of 12 months. Twenty-eight of these approvals were for priority products that were considered to be of potentially exceptional public health value. These were approved in a median time of 6.1 months. The priority and regular approvals included 35 new molecular entities that had not been previously marketed in the United States and that were approved in a median time of 11.6 months. The new molecular entities are listed in Table 1.

TABLE 1

Selected New Molecular Entity Drugs Approved in 1999

Drug Use/indication

Cilostazol (Pletal)

Treatment of intermittent claudication

Aliperetinate (Panretin)

Treatment of cutaneous lesions in patients with AIDS-related Kaposi's sarcoma

Ferric sodium gluconate complex (Ferrlecit)

Treatment of iron deficiency anemia in patients undergoing chronic hemodialysis who are receiving supplemental erythropoietin therapy

Amprenavir (Agenerase)

A protease inhibitor indicated, in combination with other antiretroviral agents, for the treatment of HIV-1 infection

Orlistat (Xenical)

Management of obesity, including weight loss and weight maintenance, when used in conjunction with a reduced-calorie diet; also indicated to reduce the risk for weight regain after prior loss.

Rofecoxib (Vioxx)

Relief of the signs and symptoms of osteoarthritis, for the management of acute pain and treatment of primary dysmenorrhea

Rosiglitazone (Avandia)

Treatment of type 2 diabetes mellitus, as monotherapy or in combination with metformin

Doxercalciferol (Hectorol)

Reduction of elevated iPTH levels in the management of secondary hyperparathyroidism in patients undergoing chronic renal dialysis

Ketotifen (Zaditor)

Prevention of itching of the eye caused by allergic conjunctivitis

Pioglitazone (Actos)

Improvement of glycemic control in patients with type 2 diabetes, as monotherapy or in combination with a sulfonylurea, metformin or insulin, when diet and a single agent do not result in adequate glycemic control

Zanamivir (Relenza)

Treatment of uncomplicated acute illness caused by influenza virus in adults and adolescents 12 years of age and older who have been symptomatic for no more than two days

Ganirelix (Antagon)

Inhibition of premature LH surges in women undergoing controlled ovarian hyperstimulation

Technetium Tc-99m depreotide (Neotect)

Patients presenting with pulmonary lesions on CT and/or chest radiograph who have known malignancy or who are highly suspect for malignancy

Temozolomide (Temodar)

Treatment of adults with refractory anaplastic astrocytoma (i.e., patients at first relapse who have experienced disease progression on a drug regimen containing a nitrosourea and procarbazine)

Zaleplon (Sonata)

Outpatients and inpatients as adjunct to general anesthesia to facilitate tracheal intubation and provide skeletal muscle relaxation during surgical procedures

Rabeprazole (Aciphex)

Healing of erosive or ulcerative GERD; maintenance of healing of erosive or ulcerative GERD; healing of duodenal ulcer; treatment of pathologic hypersecretory conditions, including Zollinger-Ellison syndrome

Sirolimus (Rapamune)

Prophylaxis of organ rejection in patients receiving renal transplants

Epirubicin (Ellence)

Component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer

Quinupristin and dalfopristin (Synercid)

Treatment of patients with serious or life-threatening infections associated with vancomycin-resistant Enterococcus faecium bacteremia

Pemirolast (Alamast)

Prevention of itching of the eye caused by allergic conjunctivitis

Dofetilide (Tikosyn)

Conversion of atrial fibrillation and flutter to normal sinus rhythm

Entacapone (Comtan)

Adjunct to levodopa/carbidopa in the treatment of patients with idiopathic Parkinson's disease who have signs and symptoms of end-of-dose “wearing off” (so-called fluctuation patients)

Exemestane (Aromasin)

Treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy

Oseltamivir (Tamiflu)

Treatment for influenza A and B

Poractant alpha (Curosurf)

Rescue treatment of RDS in premature infants

Levetiracetam (Keppra)

Adjunctive therapy in the treatment of partial-onset seizures in adults with epilepsy

Aminolevulinic acid (Levulan Kerastick)

With blue light irradiation (using the BLU-U Illuminator), is indicated for treatment of nonhyperkeratotic actinic keratoses of the face and scalp

Gadoversetamide (Optimark)

With MRI in patients with an abnormal blood barrier or abnormal vascularity of the brain, spine and associated tissues; with MRI to provide contrast enhancement and facilitate visualization of lesions with abnormal vascularity in the liver in patients who are highly suspect for liver structural abnormalities identified on CT

Mequinol, tretinoin (Solage)

Treatment of solar lentigines

Moxifloxacin (Avelox)

Treatment of acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, community-acquired pneumonia

Dexmedetomidine (Precedex)

Sedation of initially intubated and mechanically ventilated adult patients in an ICU setting

Gatifloxacin (Tequin)

Treatment of acute bacterial sinusitis, community-acquired pneumonia, acute bacterial exacerbation of chronic bronchitis, UTIs, pyelonephritis and uncomplicated gonorrhea

Nitric oxide (INOmax)

In conjunction with ventilatory support and other appropriate agents, for the treatment of term and near-term (> 34 weeks) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence or pulmonary hypertension, where it improves oxygenation and reduces the need for extracorporeal membrane oxygenation

Bexarotene (Targretin)

Treatment of cutaneous manifestations of cutaneous T-cell lymphoma in patients who are refractory to at least one prior systemic therapy


AIDS = acquired immunodeficiency disease; HIV-1 = human immunodeficiency virus-1; iPTH = immunoreactive parathyroid hormone; LH = luteinizing hormone; CT = computed tomography; GERD = gastroesophageal reflux disease; RDS = respiratory distress syndrome; MRI = magnetic resonance imaging; ICU = intensive care unit; UTIs = urinary tract infections.

TABLE 1   Selected New Molecular Entity Drugs Approved in 1999

View Table

TABLE 1

Selected New Molecular Entity Drugs Approved in 1999

Drug Use/indication

Cilostazol (Pletal)

Treatment of intermittent claudication

Aliperetinate (Panretin)

Treatment of cutaneous lesions in patients with AIDS-related Kaposi's sarcoma

Ferric sodium gluconate complex (Ferrlecit)

Treatment of iron deficiency anemia in patients undergoing chronic hemodialysis who are receiving supplemental erythropoietin therapy

Amprenavir (Agenerase)

A protease inhibitor indicated, in combination with other antiretroviral agents, for the treatment of HIV-1 infection

Orlistat (Xenical)

Management of obesity, including weight loss and weight maintenance, when used in conjunction with a reduced-calorie diet; also indicated to reduce the risk for weight regain after prior loss.

Rofecoxib (Vioxx)

Relief of the signs and symptoms of osteoarthritis, for the management of acute pain and treatment of primary dysmenorrhea

Rosiglitazone (Avandia)

Treatment of type 2 diabetes mellitus, as monotherapy or in combination with metformin

Doxercalciferol (Hectorol)

Reduction of elevated iPTH levels in the management of secondary hyperparathyroidism in patients undergoing chronic renal dialysis

Ketotifen (Zaditor)

Prevention of itching of the eye caused by allergic conjunctivitis

Pioglitazone (Actos)

Improvement of glycemic control in patients with type 2 diabetes, as monotherapy or in combination with a sulfonylurea, metformin or insulin, when diet and a single agent do not result in adequate glycemic control

Zanamivir (Relenza)

Treatment of uncomplicated acute illness caused by influenza virus in adults and adolescents 12 years of age and older who have been symptomatic for no more than two days

Ganirelix (Antagon)

Inhibition of premature LH surges in women undergoing controlled ovarian hyperstimulation

Technetium Tc-99m depreotide (Neotect)

Patients presenting with pulmonary lesions on CT and/or chest radiograph who have known malignancy or who are highly suspect for malignancy

Temozolomide (Temodar)

Treatment of adults with refractory anaplastic astrocytoma (i.e., patients at first relapse who have experienced disease progression on a drug regimen containing a nitrosourea and procarbazine)

Zaleplon (Sonata)

Outpatients and inpatients as adjunct to general anesthesia to facilitate tracheal intubation and provide skeletal muscle relaxation during surgical procedures

Rabeprazole (Aciphex)

Healing of erosive or ulcerative GERD; maintenance of healing of erosive or ulcerative GERD; healing of duodenal ulcer; treatment of pathologic hypersecretory conditions, including Zollinger-Ellison syndrome

Sirolimus (Rapamune)

Prophylaxis of organ rejection in patients receiving renal transplants

Epirubicin (Ellence)

Component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer

Quinupristin and dalfopristin (Synercid)

Treatment of patients with serious or life-threatening infections associated with vancomycin-resistant Enterococcus faecium bacteremia

Pemirolast (Alamast)

Prevention of itching of the eye caused by allergic conjunctivitis

Dofetilide (Tikosyn)

Conversion of atrial fibrillation and flutter to normal sinus rhythm

Entacapone (Comtan)

Adjunct to levodopa/carbidopa in the treatment of patients with idiopathic Parkinson's disease who have signs and symptoms of end-of-dose “wearing off” (so-called fluctuation patients)

Exemestane (Aromasin)

Treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy

Oseltamivir (Tamiflu)

Treatment for influenza A and B

Poractant alpha (Curosurf)

Rescue treatment of RDS in premature infants

Levetiracetam (Keppra)

Adjunctive therapy in the treatment of partial-onset seizures in adults with epilepsy

Aminolevulinic acid (Levulan Kerastick)

With blue light irradiation (using the BLU-U Illuminator), is indicated for treatment of nonhyperkeratotic actinic keratoses of the face and scalp

Gadoversetamide (Optimark)

With MRI in patients with an abnormal blood barrier or abnormal vascularity of the brain, spine and associated tissues; with MRI to provide contrast enhancement and facilitate visualization of lesions with abnormal vascularity in the liver in patients who are highly suspect for liver structural abnormalities identified on CT

Mequinol, tretinoin (Solage)

Treatment of solar lentigines

Moxifloxacin (Avelox)

Treatment of acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, community-acquired pneumonia

Dexmedetomidine (Precedex)

Sedation of initially intubated and mechanically ventilated adult patients in an ICU setting

Gatifloxacin (Tequin)

Treatment of acute bacterial sinusitis, community-acquired pneumonia, acute bacterial exacerbation of chronic bronchitis, UTIs, pyelonephritis and uncomplicated gonorrhea

Nitric oxide (INOmax)

In conjunction with ventilatory support and other appropriate agents, for the treatment of term and near-term (> 34 weeks) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence or pulmonary hypertension, where it improves oxygenation and reduces the need for extracorporeal membrane oxygenation

Bexarotene (Targretin)

Treatment of cutaneous manifestations of cutaneous T-cell lymphoma in patients who are refractory to at least one prior systemic therapy


AIDS = acquired immunodeficiency disease; HIV-1 = human immunodeficiency virus-1; iPTH = immunoreactive parathyroid hormone; LH = luteinizing hormone; CT = computed tomography; GERD = gastroesophageal reflux disease; RDS = respiratory distress syndrome; MRI = magnetic resonance imaging; ICU = intensive care unit; UTIs = urinary tract infections.

The FDA approved 20 orphan drugs, biologics and devices in 1999 for the treatment of rare diseases with patient populations too small to make the development of such drugs and devices routinely profitable.

Cancer

Some significant approvals for the treatment or diagnosis of cancer include epirubicin (Ellence) for the treatment of early-stage breast cancer that has spread to the underarm lymph nodes and has been treated surgically with removal of all of the known tumor; temozolomide (Temodar) for the treatment of adults with a relapsed anaplastic astrocytoma, a form of brain cancer; and a new indication for docetaxel (Taxotere) as a treatment for non-small cell lung cancer that does not respond to cisplatin-based chemotherapy. In addition, CDER approved a drug/device using aminolevulinic acid (Levulan Kerastick) for the treatment of certain precancerous skin lesions. This is the first device of its kind.

The contribution of the Center for Biological Evaluation and Research to the fight against cancer was the approval of denileukin diftitox (Ontak), a biologic treatment for patients with advanced or recurrent cutaneous T-cell lymphoma who have not been helped by other treatments (Table 2). The Center for Devices and Radiological Health approved the TranScan T-Scan 2000, a new imaging device that will help radiologists determine if a woman should be evaluated further when her mammogram results are ambiguous.

TABLE 2

Significant New Biologic Products Approved in 1997

Product Use/indication

Denileukin diftitox (Ontak)*†

Treatment of persistent or recurrent cutaneous T-cell lymphoma

Hepatitis B immune globulin, human (Nabi-HB)

For acute exposure to blood containing HBsAg; perinatal exposure to infants born to HBsAg-positive mothers; sexual exposure to HBsAg-positive persons; household exposure of infants born to persons with acute HBV infections

Interferon alfa-nl, lymphoblastoid (Wellferon)*

Treatment of hepatitis C in patients 18 years of age or older without decompensated liver disease

Coagulation factor VIIa, recombinant (NovoSeven)*†

Treatment of bleeding episodes in patients with hemophilia A and B with inhibitors to factors VIII or IX

Antihemophilic factor/von Willebrand factor complex, human (Humane-P)*†

Prevention and control of hemorrhagic episodes in hemophilia A patients; new indication for treatment of von Willebrand disease


*—First approval for product.

†—Orphan designation.

HBsAg = hepatitis B surface antigen; HBV = hepatitis B virus.

TABLE 2   Significant New Biologic Products Approved in 1997

View Table

TABLE 2

Significant New Biologic Products Approved in 1997

Product Use/indication

Denileukin diftitox (Ontak)*†

Treatment of persistent or recurrent cutaneous T-cell lymphoma

Hepatitis B immune globulin, human (Nabi-HB)

For acute exposure to blood containing HBsAg; perinatal exposure to infants born to HBsAg-positive mothers; sexual exposure to HBsAg-positive persons; household exposure of infants born to persons with acute HBV infections

Interferon alfa-nl, lymphoblastoid (Wellferon)*

Treatment of hepatitis C in patients 18 years of age or older without decompensated liver disease

Coagulation factor VIIa, recombinant (NovoSeven)*†

Treatment of bleeding episodes in patients with hemophilia A and B with inhibitors to factors VIII or IX

Antihemophilic factor/von Willebrand factor complex, human (Humane-P)*†

Prevention and control of hemorrhagic episodes in hemophilia A patients; new indication for treatment of von Willebrand disease


*—First approval for product.

†—Orphan designation.

HBsAg = hepatitis B surface antigen; HBV = hepatitis B virus.

From HIV to Obesity

Other important medications approved in 1999 include amprenavir (Agenerase), a protease inhibitor for the treatment of human immunodeficiency virus infection in children more than four years of age and adults; a combination of aspirin and dipyridamole (Aggrenox) that reduces the risk of a second stroke related to blood clots in the brain; levetiracetam (Keppra), an epilepsy drug that helps control partial-onset seizures in adults; Humate-P, a plasma-derived antihemophilic factor/von Willebrand factor complex as a new indication for the treatment of von Willebrand's disease; dalfopristin (Synercid), the first antibacterial agent to treat infections associated with vancomycin-resistant Enterococcus faecium; sirolimus (Rapamune), an immunosuppressant drug to prevent acute organ rejection in patients receiving kidney transplants; rofecoxib (Vioxx), a COX-2 inhibitor for the treatment of osteoarthritis, menstrual pain and other acute pain in adults; NovoSeven Coagulation Factor VIIa (recombinant) for the treatment of bleeding episodes in patients with hemophilia A or B with inhibitors to coagulation Factors VIII or IX; and orlistat (Xenical), a new lipase inhibitor for the treatment of obesity.

Hepatitis, Pneumonia, Lyme Disease

Patients with hepatitis, pneumonia and Lyme disease can be treated earlier and with greater assurance thanks to the following tests that were labeled in 1999: (1) the Hepatitis C Check, the first home test for the hepatitis C virus, and an improved supplemental test, the RIBA HCV 3.0 Strip Immunoblot Assay, to confirm screening test results for antibodies to the hepatitis C virus; (2) Binax NOW Streptococcus Pneumoniae Urinary Antigen test, a first-of-a-kind urine test for detecting Streptococcus pneumoniae; and (3) the PreVue B. burgdorferi Antibody Detection Assay, a simple new blood test for antibodies to Lyme disease that can be used in the office.

Influenza

Two new influenza medications, the first new treatments for this condition since 1993, were labeled last year: oseltamivir (Tamiflu), an oral antiviral medicine for adults whose influenza symptoms have lasted no more than two days; and zanamivir (Relenza), an inhaled antiviral medication for adults and adolescents more than 12 years of age who have uncomplicated influenza.

Myopia

Nearsighted patients can be helped by two new devices labeled by the FDA last year: KeraVision Intacs, which are tiny acrylic crescents that can be implanted in the eye to correct mild nearsightedness, and SVS Apex Plus Excimer Laser Workstation, an eye laser for use in correcting myopia, with or without astigmatism, in adults.

Diabetes

Patients with diabetes now have three more products to help manage the disease and improve their quality of life: pioglitazone (Actos) and rosiglitazone (Avandia), new drugs in the thiazolidinedione class for the treatment of type 2 diabetes (formerly known as non–insulin-dependent diabetes); and the Continuous Glucose Monitoring System, the first device that provides physicians with continuous measures of tissue glucose levels in adults through a sensor inserted under the skin and connected to a small external monitor.

Cardiac Conditions

Cardiac patients can benefit from several devices labeled by the FDA last year: the Ancure Tube and Bifurcated Endovascular Grafting Systems are designed to permit treatment of aortic aneurysms in the abdomen without major abdominal surgery; and the AngioJet System, which removes blood clots from blocked heart arteries or bypass grafts before angioplasty.

Also approved are the Eclipse TMR Holmium Laser System, a transmyocardial revascularization system that creates tiny holes in the heart muscle in areas inaccessible to treatment by coronary artery bypass; the Cardioseal Septal Occlusion System, a transvascular method of closing holes between the left and right sides of the heart for use in a selected population; and the Ensite 3000 and the Tracer 02T-W Mapping Device, two mapping systems for diagnosing complex atrial arrhythmias to assist in planning appropriate treatment.

Thomas J. McGinnis, R.Ph., is Director of Pharmacy Affairs in the Office of Policy for the U.S. Food and Drug Administration.

Coordinator of this quarterly series from the U.S. Food and Drug Administration is Mike Kubic of the Office of Public Affairs.


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