 |
About CDER - Report |
U.S. Food and Drug Administration • Center for Drug Evaluation and Research |
|
About CDER - Report |
 |
CDER Report to the Nation: 2000 Drug ReviewMany Americans benefited from last year's timely reviews of new prescription medicines, over-the-counter medicines and their generic equivalents. We met or exceeded nearly all goals for reviews supported by manufacturer user fees. We approved 27 new medicines that have never been marketed before in this country and 244 generic versions of existing drugs. We authorized eight medicines to be sold over the counter without a prescription. We conducted 528 foreign and domestic inspections that help protect volunteers for clinical trials from research risks and validate the quality and integrity of data submitted to us. Highlights of new medication options for American consumers include:
MissionWe promote the public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of human drugs in a timely manner. 2000 drug review accomplishments
New drug statistics
New molecular entity statistics
Median timeThe median time is a value that falls in the middle of all times. It provides a truer picture of performance than average time, which can be unduly influenced by a few extremely long or short times. Information on average, or mean, approval times and other statistics are available on our Web site at http://www.fda.gov/cder/rdmt/default.htm. New Drug ReviewWe took 238 actions on original new drug applications, of which 98 were approvals. In 1999, we took 190 actions, of which 83 were approvals. Total original NDA approvalsThe median total approval time for new drugs in 2000 was 11.2 months, compared with 12.0 in 1999. Approval time represents our total review time plus industry response time to our requests for additional information. The 10.9-month median FDA review time-our time only-was 8 percent shorter in 2000 than the 11.8 months in 1999. Three of the NDAs were approved for "orphan" uses in patient populations of 200,000 or fewer. In 1999, we approved 12 NDAs for orphan uses. Priority reviewsThe new drug approvals in 2000 included 20 priority reviews. We perform a six-month review on priority drugs because they represent an advance in medical treatment. The median total approval time and the median FDA review time for these priority reviews were both 6.0 months. In 1999, there were 28 priority reviews. New molecular entity approvalsTwenty-seven of the original new drugs we approved in 2000 were new molecular entities. NMEs contain an active substance that has never before been approved for marketing in any form in the United States. Nine of these received priority approvals. The median total approval time for NMEs was 15.6 months, and the median FDA review time was 13.9 months. These times were longer than those for all NDAs. Last year the number of NDAs approved increased from the previous year, but the number of NMEs approved fell. Although user fee goals were met, the longer times for some drugs had a disproportionately larger effect on NME statistics. In 1999, there were 35 NMEs approved. Note: click on charts to view larger versions.
Notable 2000 new drug approvalsLast year's approvals benefited people with cancer, HIV, diabetes, heart disease and disorders of the circulatory and nervous systems. People with cancerArsenic trioxide (Trisenox) treats acute promyelocytic leukemia, a cancer of white blood cells, in patients whose disease has recurred or who have failed to respond to standard therapy. Trisenox, a priority drug and an orphan drug, was approved in six months. The product's total development time for this use was only three years. Gemtuzumab ozogamicin (Mylotarg), a monoclonal antibody, is a priority orphan drug for treating CD33 (an antigen on certain leukemia cells) positive acute myeloid leukemia in patients 60 years or older who have relapsed for the first time and are not suitable candidates for the standard but poorly tolerated cytotoxic therapy. Triptorelin pamoate (Trelstar Depot) is for the palliative treatment of advanced prostate cancer. It represents a new alternative for patients with prostate cancer in whom orchiectomy or estrogen administration is not indicated or is unacceptable. People with HIV and AIDSA combination of lopinavir and ritonavir (Kaletra) received accelerated approval as a protease inhibitor for the treatment of HIV infection in adults and children in combination with other antiretroviral agents. The product, indicated for twice daily dosing with a total of six capsules per day, is the only protease inhibitor approved for use in children as young as 6 months. People with heart and circulatory diseasesArgatroban (Acova) is an anticoagulant for the prevention or treatment of thrombosis (abnormal blood clotting) associated with heparin-induced thrombocytopenia, a serious immune disorder caused by heparin, a common anticoagulant used to prevent blood clots. Bivalirudin (Angiomax) is an anticoagulant for use in patients with unstable angina who are undergoing coronary angioplasty. It is to be used with aspirin. Colesevelam (WelChol) is used in conjunction with diet and exercise for the reduction of elevated LDL cholesterol in patients with primary hypercholesterolemia. The novel, non-absorbed, lipid-lowering agent is to be administered alone or in combination with an HMG-CoA reductase inhibitor (statin). Tinzaparin (Innohep), a low-molecular-weight heparin, is a once-daily treatment for deep vein thrombosis with or without pulmonary embolism when administered in conjunction with warfarin. People with diabetesInsulin aspart recombinant (NovoLog) is for the treatment of type 1 and type 2 diabetes. Insulin glargine (Lantus) is a long-acting recombinant human insulin for type 1 and type 2 diabetes. Nateglinide (Starlix), the first in a new class of drugs, is for the treatment of type 2 diabetes. People with gastrointestinal disordersAlosetron (Lotronex) was to treat irritable bowel syndrome in women whose predominant bowel symptom is diarrhea, but the drug was withdrawn by the manufacturer. Balsalazide disodium (Colazal) is for the treatment of mild to moderately active ulcerative colitis, a chronic and debilitating inflammatory disease of the gastrointestinal tract. Pantoprazole (Protonix), a proton pump inhibitor, is a delayed-release tablet for the short-term (up to 16 weeks) treatment in the healing and symptomatic relief of erosive esophagitis. People with neurological disordersOxcarbazepine (Trileptal) is for treatment of epileptic partial seizures as monotherapy in adults or as adjunctive therapy in adults and children as young as 4. Rivastigmine tartrate (Exelon), a cholinesterase inhibitor, treats mild to moderate Alzheimer's disease. Zonisamide (Zonegran) is for adjunctive therapy in the treatment of partial seizures in adults with epilepsy. Infectious diseasesDocosanol (Abreva) is an over-the-counter topical treatment for recurrent oral-facial herpes simplex infections, commonly known as cold sores or fever blisters. Linezolid (Zyvox) is the first antibiotic in a new class in 35 years (the oxazolidinones) to treat infections caused by gram-positive bacteria. Gram-positive bacteria are regarded as one of the greatest challenges in hospitals. Oseltamivir (Tamiflu) oral suspension was approved for prevention of influenza virus in adults and adolescents aged 13 years and older. Zanamivir (Relenza) treats uncomplicated influenza A and B in adults and children 7 years and older. People with thyroid diseaseLevothyroxine sodium (Unithroid), a thyroid replacement drug, is the first single-ingredient oral levothyroxine product approved for the treatment of hypothyroidism, a disease that causes mental and physical sluggishness, including stunted growth. Although oral levothyroxine drugs products have been marketed in the United States since the 1950s, this product meets FDA's standards for safety and effectiveness as well as its standards for manufacturing processes, purity, potency and stability. People with eye diseaseVerteporfin for injection (Visudyne) is the first therapy to slow vision loss in people with the classic type of wet age-related macular degeneration, a disease that can cause blindness. Unoprostone isopropyl (Rescula) treats open-angle glaucoma or ocular hypertension. People with severe eczemaTacrolimus (Protopic) is an ointment for patients with moderate or severe eczema for whom standard eczema therapies present potential risks or who are not adequately treated by or do not tolerate standard eczema therapies. Children with asthmaBudesonide inhalation suspension (Pulmicort Respules) is approved for children 1 to 8 years old with asthma. The product is the first anti-inflammatory corticosteroid formulated for inhalation using a nebulizer in this age group. This is important because toddlers frequently cannot use metered-dose inhalers. Other NME approvalsArticaine 4 percent and epinephrine hydrochloride (Septocaine) is a local anesthetic to be used for simple and complex dental and periodontal procedures. Cetrorelix acetate (Cetrotide) prevents premature ovulation in women undergoing controlled ovarian stimulation for assisted reproductive treatment. Meloxicam (Mobic) tablets are a once-daily treatment for the pain and stiffness associated with osteoarthritis. Mifepristone (Mifeprex) is to terminate pregnancies of 49 days or less from the beginning of a woman's last menstrual period. Perfluoropolymethylisopropyl ether/polytetrafluoroethylene (Skin Exposure Reduction Paste Against Chemical Warfare Agents), when used with Mission Oriented Protective Posture gear, reduces or delays the absorption of such agents through the skin when the paste is applied prior to exposure. Malaria treatmentA combination of atovaquone and proguanil (Malarone) is for the prevention and treatment of acute, uncomplicated malaria. It has been shown to be effective in regions where the disease has become resistant to other anti-malarial drugs. PET drug initiativeWe approved F-18 FDG, an injected radiopharmaceutical drug that localizes areas with abnormal glucose metabolism to assist in cancer assessments and in identifying reversible cardiac dysfunction. It was approved as part of an initiative under the FDA Modernization Act of 1997, which included consultations with the public and an advisory committee, a review of literature and a Federal Register notice describing how the drug could be found to be safe and effective for certain indications. Orphan drug approvalsIn 2000, we approved three "orphan" products to treat disorders with patient populations of 200,000 or fewer: Arsenic trioxide (Trisenox) treats acute promyelocytic leukemia, a cancer of white blood cells, in patients whose disease has recurred or who have failed to respond to standard therapy. Somatropin, recombinant (Norditropin) is indicated for the long-term treatment of children who have growth failure due to inadequate secretion of endogenous growth hormone. Gemtuzumab ozogamicin (Mylotarg) treats CD33-positive acute myeloid leukemia in patients 60 years or older who have relapsed for the first time and are not suitable candidates for the standard but poorly tolerated cytotoxic therapy. Priority new drug approvals (N=NME)
New molecular entities in 2000
New or Expanded Use ReviewApplications for a new or expanded use, often representing important new treatment options, are formally called "efficacy supplements" to the original new drug application. Last year we took action on 205 applications for new or expanded uses of already approved drugs. We approved 134, including 18 that were given priority reviews of six months or less. Five of the approvals were for orphan uses in patient populations of 200,000 or fewer. Efficacy supplement statistics
Notable 2000 new or expanded use approvals
Priority efficacy supplement approvals
Orphan efficacy supplement approvals
Note: Click on charts to view larger versions.
Over-the-Counter Drug ReviewIn 2000, we approved eight new drugs and three new uses for over-the-counter marketing. New OTC medicines and new uses
Over-the-counter drug statistics
Public meeting airs OTC drug issuesWe are open to the possibility of having more and different kinds of OTC medicines available to consumers. We explored these issues with more than 300 stakeholders at a two-day public meeting. Discussions included how we determine which drugs should be available over the counter, who should initiate Rx-to-OTC switches and safety concerns about OTC availability of medicines for chronic conditions without symptoms. A brief report of the meeting is available at: http://www.fda.gov/cder/pike/july2000.htm#OTC. Improved labels for OTC medicinesAmerican consumers last year began to see new, easy-to-understand labels on nonprescription drugs. Titled "Drug Facts," the new labels are the result of a regulation we issued in 1999. These new labels will improve a consumer's ability to use an OTC drug safely and properly and to find and understand its benefits and risks. How we regulate OTC drugsWe publish monographs that establish acceptable ingredients, doses, formulations and consumer labeling for OTC drugs. Products that conform to a final monograph may be marketed without prior FDA clearance. Drugs can also be approved for OTC sale through the new drug review process. Note: click on chart to view larger version.
|
Back to Top 
Back to About CDER
FDA/Center for Drug Evaluation and Research
Last Updated: June 14, 200119 Jan 2006 14:03:16 -0500
Originator: OTCOM/DCM
HTML by JO, PKS
