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About CDER - Report |
U.S. Food and Drug Administration • Center for Drug Evaluation and Research |
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About CDER - Report |
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CDER Report to the Nation: 1999 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 35 new medicines that have never been marketed before in this country, 186 generic versions of existing drugs and authorized four medicines to be sold over the counter without a prescription. 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. 1999 drug review accomplishments:
New Drug ReviewWe took 190 actions on original new drug applications, of which 83 were approvals. The proportion of total actions that are approvals has risen steadily from under one-third in 1993 to approximately half in recent years. The lower number of actions represents a decline in the number of applications submitted to us. The higher percentage of approvals in recent years stems from our increased predictability and accountability and improved performance on the part of manufacturers. Total original NDA approvalsThe median total approval time for new drugs acted on in 1999 was 12.0 months, the same as in 1998. Approval time represents the total review time at the Agency plus industry response time to the Agency's requests for additional information. The median FDA review time-FDA time only-was slightly shorter at 11.8 months. Twelve of the NDAs were approved for "orphan" uses in patient populations of 200,000 or fewer. In 1998, nine NDAs were approved for orphan uses. Priority reviewsLast year's new drug approvals included 28 priority drugs. We perform a six-month review on priority drugs because these drugs represent an advance in medical treatment. The median total approval time for these priority applications was 6.1 months, and the median FDA review time was also 6.1 months. New molecular entity approvalsThirty-five of the original new drugs we approved in 1999 were new molecular entities, and 19 of these received priority approvals. The median total approval time for NMEs was 11.6 months. NMEs contain an active substance that has never before been approved for marketing in any form in the United States. The median FDA review time was 10.0 months. Sixteen of the 30 NMEs approved in 1998 were priority reviews. Eight of the 1999 NMEs were for orphan uses compared to seven in 1998.
New drug statistics:
Notable 1999 new drug approvalsLast year's approvals benefited people with rare disorders, those with HIV infection, older Americans and people with diabetes and other disorders. People with rare diseasesTwelve of the new drugs approved last year are for rare diseases with patient populations too small to make the development of such drugs and devices routinely profitable. We approve these drugs under the 16 year-old Orphan Drug Program which grants special privileges and marketing incentives for drugs that treat conditions affecting fewer than 200,000 Americans. Bexarotene (Targretin) offers new hope for patients with rare forms of cancer, including those who have advanced or recurrent cutaneous T-cell lymphoma, a slow-growing form of non-Hodgkin's lymphoma, and who have not been helped by other treatments. Epirubicin hydrochloride injection (Ellence) treats early stage breast cancer that has spread to the lymph nodes under the arm and has been treated surgically. Epirubicin is commonly used in combination with other medications to slow or halt the progression of cancer. Adult patients who have anaplastic astrocytoma, a rare form of brain cancer, and who have relapsed after chemotherapy can now be treated with temozolomide (Temodar). Infants and children with rare diseases could benefit from several new drugs approved under the Orphan Drug Program. Caffeine citrate (Cafcit) is a short-term pediatric treatment for apnea (breathing interruptions), and poractant alfa (Curosurf) can be used for relief from the respiratory distress syndrome. Another new product for respiratory failure in term or near-term infants is nitric oxide (INOmax). People with CancerIn addition to epirubicin (Ellence), which was approved under the Orphan Drug Program, we approved exemestane (Aromasin) for advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy. A potentially cancer-preventing product is aminolevulinic acid hydrochloride (Levulan Kerastick), the first drug/device for the treatment of precancerous skin lesions on the face and scalp. People with HIV and AIDSAmprenavir (Agenerase), a new protease inhibitor received an accelerated approval for use in children as young as 4 and in adults in combination with other anti-retrovirals for HIV infection. Amprenavir is one of five protease inhibitors that attempt to prevent HIV from making new copies of itself by interfering with the HIV protease enzyme. Another new HIV product is alitretinoin (Panretin), a topical gel for the treatment of skin lesions in patients with AIDS-related Kaposi's sarcoma. Older peopleRofecoxib (Vioxx), a new drug for treatment of osteoarthritis, menstrual pain and the management of acute pain in adults, is a type of nonsteroidal anti-inflammatory drug (NSAID) known as a "Cox-2 inhibitor." NSAIDs temporarily relieve pain by blocking the body's production of prostaglandins, the chemicals believed to be associated with the pain and inflammation of injuries and immune reactions. A combination of aspirin and extended-release dipyridamole (Aggrenox) reduces the risk of stroke in people who have had transient ischemia attack or completed stroke. Dofetilide (Tikosyn) is an anti-arrhythmic agent for the maintenance and conversion of normal sinus rhythm in patients with highly symptomatic atrial fibrillation and atrial flutter, types of irregular heartbeats. Cilostazol (Pletal) is for treating stable intermittent claudication, a severe pain, aching or cramping in the legs that occurs with walking. Entacapone (Comtan) enhances the benefits of standard treatment for Parkinson's disease. Zaleplon (Sonata) is for the short-term treatment of insomnia in adults, including elderly patients. People with Diabetes.Patients with type II or adult-onset diabetes who are not adequately controlled by diet and exercise alone can be treated with pioglitazone (Actos) or rosiglitazone (Avandia). These medicines are members of the thiazolidinedione class of drugs that can improve the body's ability to use insulin. Infectious diseasesDalfopristin and quinupristin injection (Synercid) is the first antibacterial drug to treat infections caused by vancomycin-resistant Enterococcus faecium, which has become highly resistant to older antibiotics. This drug was also approved for complicated skin and skin structure infections. Gatifloxacin (Tequin) is a new type of quinolone antibiotic for treating community-acquired respiratory tract infections such as pneumonia, acute exacerbation of chronic bronchitis and acute sinusitis. Moxifloxacin hydrochloride (Avelox) is a once-a-day antibiotic to treat common respiratory tract infections, including bacterial exacerbations of chronic bronchitis, community-acquired pneumonia of mild to moderate severity and acute bacterial sinusitis. Two anti-viral therapies treat people infected with the virus that causes influenza. These are zanamivir (Relenza), an inhaled drug for adults and adolescents who are 12 or older, and oseltamivir phosphate (Tamiflu), a capsule indicated for onset of influenza A and B. Other significant approvalsDexmedetomidine hydrochloride (Precedex) is a sedative for people in intensive care settings who have undergone major surgery. Doxecalciferol (Hectoral) helps manage secondary hyperparathyroidism in patients undergoing chronic renal dialysis. Gadoversetamide (OptiMARK) is a magnetic resonance imaging agent to help diagnose lesions, including tumors, of the brain, spine and liver. Ganirelix acetate (Antagon) reduces in vitro fertilization treatment times from four weeks to about 10 days and simplifies treatment regimens. Ketotifen fumarate (Zaditor) is an ophthalmic solution for the temporary relief of itchy eyes due to allergic conjunctivitis. Levetiracetam (Keppra) is a new epilepsy drug that helps control partial onset seizures in adults. Orlistat (Xenical) is a lipase inhibitor to treat obesity. Rabeprazole sodium (Aciphex) is a once-a-day proton pump inhibitor to heal duodenal ulcers and erosive gastroesophageal reflux disease. Pemirolast potassium (Alamast) is an ophthalmic solution to prevent itchy eyes caused by allegic conjunctivitis. Rapacuronium bromide (Raplon) is an adjunct to general anesthesia to facilitate tracheal intubation and provide skeletal muscle relaxation. Sirolimus (Rapamune) is the first in a new class of immunosuppressant agents that prevent organ rejection in people with transplants. Sodium ferric gluconate (Ferrlecit) treats iron deficiencyin end-stage renal disease for patients in hemodialysis who are receiving erythropoietin therapy. The technetium Tc 99m depreotide kit (NeoTect) is for imaging suspected malignant tumors in the lung. Priority new drug approvals:
1999 new molecular entities:
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 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 184 applications for new or expanded uses of already approved drugs. We approved 97, including nine that were given priority reviews of six months or less. Four of the approvals were for orphan uses in patient populations of 200,000 or fewer. The median total approval time was 10.4 months, and median FDA review time was 10.2 months. Efficacy supplement statistics:
Notable 1999 new or expanded use approvalsCelecoxib (Celebrex), a nonsteroidal anti-inflammatory drug first approved in 1999 to treat arthritis, is the first drug treatment (together with endoscopic surveillance or surgery) for familial adenomatous polyposis, a genetic disorder. The new indication is for the reduction in the number of adenomatous colorectal polyps, which greatly increase the risk of developing colon and rectal cancer in young patients. This indication was given an accelerated approval as a product that promised therapeutic benefit for a life-threatening condition that has no other acceptable treatment. Docetaxel (Taxotere), which was originally designed for treating patients with advanced breast cancer, and now is approved for use in non-small cell lung cancer that does not respond to chemotherapy. Paroxetine hydrochloride (Paxil) is the first drug to receive FDA approval to treat social phobia Sertraline hydrochloride (Zoloft) is the first drug for posttraumatic stress disorder, which has long been recognized as an important clinical problem. Somatropin (Nutropin Depot), a genetically engineered drug, was approved for long-term treatment of growth failure. Priority efficacy supplement approvals
Electronic submissionsOne of the advantages of the FDA review system is the availability of complete data for reviewers. A bulky component of the application consists of case report forms and case report tabulations. We have been accepting the archive copy of these in electronic format since November 1997. In January 1999, we published guidances that provide for the receipt and archiving of a new drug application entirely in electronic format without an accompanying paper archival copy. We expanded our electronic document room to manage the receipt and handling of full electronic new drug applications. We conducted workshops to assist industry in preparing their electronic submissions and trained our reviewers in using electronic submissions. The majority of original new drug applications now include electronic components. In addition, we expanded our internal electronic document management system so that we can electronically archive all of our documents for investigational new drug applications and new drug applications. Pregnancy labelingWe have reviewed the current system of labeling drugs for use by pregnant women and developed an improved, more comprehensive and clinically meaningful approach. We consulted multiple government agencies, medical experts, consumer groups and the pharmaceutical industry in developing two draft guidances for industry and a preliminary discussion paper. PediatricsWe are authorized to grant six months of marketing exclusivity to manufacturers who conduct and file pediatric studies in response to our written request. We have reviewed more than 175 proposed study requests from industry and issued more than 140 written requests asking for more than 200 studies. Over-the-Counter Drug ReviewIn 1999, we approved four new drugs and four new uses for over-the-counter marketing. New OTC medicines and new uses
Over-the-counter drug statistics:
Improved Labels for OTC MedicinesConsumers will soon find it easier to use over-the-counter medicines as a result of a final rule we published in 1999 that will provide new, easy-to-understand labels on nonprescription drugs. The regulation calls for a standardized format that will improve the labels on drugs Americans use most-nonprescription, or over-the-counter drugs. By clearly showing a drug's ingredients, dose and warnings, the new labels will make it easier for consumers to understand information about a drug's benefits and risks as well as its proper use. Titled "Drug Facts," the new label will make it easier for consumers to identify active ingredients, which will be listed at the top, followed by uses, warnings, directions and inactive ingredients. The rule also sets minimum type sizes and other graphic features for the standardized format, including options for modifying the format for various package sizes and shapes. OTC drug factsAs Americans continue to participate more actively in their health care decisions, many medications purchased are OTC drugs. Currently, there are more than 100,000 OTC products on the market. However, fewer than 1,000 active ingredients are used in all OTC products. The expanding availability of OTC drugs reclassified from prescription status offers consumers greater choices. More than 600 OTC products use ingredients and dosages available only by prescription 20 years ago. OTC drug monographsOne of our goals is to 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 further FDA clearance.
FDA/Center for Drug Evaluation and Research |
