Important note: Information in this article was accurate in 1994. The state of the art may have changed since the publication date.
Food and Drug Administration, January 13, 1994
Mike Shaffer (301) 443-3285
Twenty-five of the new drug approvals are for new molecular entities (NMEs) -- drugs distinctly different in structure from those already on the market. Thirteen of these 25 new prescription drugs are in the "priority" classification -- drugs that are expected to have important therapeutic value. There were nine orphan drugs approved of which six are NMEs. In addition, three new biological products were designated as orphan products. Orphan products are medications developed under a special program to assist manufacturers of products for small numbers of potential patients.
Noteworthy drug approvals include Parke-Davis' Cognex, the first product ever approved to treat Alzheimer's disease, and Forest Laboratories' Flumadine for treating flu.
Major biological approvals include Genentech's Pulmozyme (also known as DNase), the first recombinant product developed specifically to improve lung function in cystic fibrosis patients, and an additional approval for Chiron's Betaseron for multiple sclerosis.
Other important biological approvals include Kogenate from Miles Inc., the second clotting factor for hemophilia A produced by recombinant techniques, and vaccines for various combinations of haemophilus, tetanus, diphtheria and pertussis.
Two of the 1993 approvals are for AIDS-related conditions. One -- U.S. Biosciences' Neutrexin for treating pneumocystis carinii pneumonia -- is a drug. Miles Inc.'s Gamimune-N for decreasing the frequency of bacterial infections in children with HIV is a biological product.
In 1993, FDA approved two new vaccines, one for haemophilus influenza, the other for a combination of DTP and haemophilus influenza.
In addition to the biological Betaseron for multiple sclerosis, five new drugs approved in 1993 are for neurological conditions, including two for epilepsy -- Carter-Wallace's Felbatol and Parke-Davis' Neurontin. The agency also approved two products to treat eye infections -- Alcon Laboratory's Alomide and Iolab's Livostin.
FDA also approved 1,314 drug supplements which are changes or additional uses for drugs that are already on the market.
The median review time for the 25 NMEs approved in 1993 was 23.0 months, compared to 22.6 months for 1992. The median review time for all NDAs was 24.1 months, compared to 26.7 the previous year. The median review time for the 13 priority NMEs was 15.0 months compared to 14.2 months for the 11 priority NMEs approved in 1992.
Three drugs -- including Parke-Davis' Cognex and Miles Laboratories' Trasylol -- were approved in less than 11 months; the the other -- Orlaam, Biometric Research's product to treat dependence on opiates such as morphine -- was approved in about 3 weeks. Eleven other NMEs were approved in 23 months or less.
The average review time for the 23 major biological products was 23.9 months compared to 31.9 months for 16 similar products approved last year.
FDA's Office of Generic Drugs approved 249 generic drug applications in 1993 compared to 229 last year. Included are 32 distinct "first time" approvals for generic products not previously available in generic form. These include generic versions of brand name drugs such as Xanax, Lotrim, Cardizem, Lopid, Lopressor and Monistat. Also approved were 2,771 generic drug supplements.
All figures presented are for calendar years. The total number of new approvals -- 370 -- included 70 drug approvals (which includes the 25 NMEs), the 51 biologics approvals (which includes the 23 major biologic products) and the 249 generic drug applications approved. The total number of approvals in 1992 was 387.
The 25 NMEs approved by FDA's Center for Drug Evaluation and Research during 1993 are:
PRODUCT NAME/FORM MANUFACTURER INDICATIONS/USE RATING GENERIC NAME
Omniscan I 1 Sterling Drug Imaging agent 1S Gadodiamide Collegeville, PA
Leustatin I 2 Ortho Biotech Hairy cell 1P Cladribine Raritan, NJ leukemia O
Lovenox I 3 Rhone-Poulenc Rorer Anticoagulant 1P Enoxaparin Fort Washington, PA
Claritin T 4 Schering Corp. Allergic 1S Loratadine Kenilworth, NJ rhinitis
Metastron I 5 Medi-Physics Analgesic 1P Strontium Sr-89 Arlington Heights, IL
Orlaam L 6 Biometric Research Opiate 1P Levomethadyl Arlington, VA addiction O acetate
Felbatol T 7 Carter-Wallace Epilepsy 1P Felbamate Cranbury, NJ O
Propulsid T 8 Janssen Pharmaceutica Nighttime 1S Cisapride Titusville, NJ heartburn
Imagent L 9 Alliance Pharm. Bowel imaging 1P Perflubron San Diego, CA agent
Demadex T & I 10 Boehringer Ingelheim Edema 1S Torsemide Ridgefield, CT
Cognex C 11 Parke-Davis Alzheimer's 1P Tacrine HCl Morris Plains, NJ Disease
Flumadine T & S 12 Forest Laboratories Preventing flu 1P Rimantadine HCl St. Louis, MO
Alomide H 13 Alcon Laboratories Eye infections 1S Iodoxamide tro- Fort Worth, TX O methamine
Zosyn I 14 Lederle Laboratories Antibiotic 1,4S Piperacillin sodium Wayne, NJ with tazobactam sodium
Livostin H 15 Iolab Allergic 1P Levocabastine HCl Claremont, CA conjunctivitis
Neutrexin I 16 U.S. Bioscience Pneumocystis 1P Trimetrexate W. Conshohocken, PA carinii pneu- AA glucuronate monia in AIDS O,E patients
Effexor T 17 Wyeth-Ayerst Antidepressant 1S Venlafaxine HCl Philadelphia, PA
Trasylol I 18 Miles, Inc. Preventing blood 1P Aprotinin Elkhart, IN loss during heart O surgery
Kytril I 19 SmithKline Beecham Preventing nausea 1S Granisetron HCl Pittsburgh, PA & vomiting during cancer chemotherapy
Risperdal T 20 Janssen Pharmaceutica Psychotic 1P Risperidone Titusville, NJ disorders
Dovonex O 21 Bristol-Myers Squibb Psoriasis 1S Calcipotriene Princeton, NJ
Aceon T 22 Ortho Pharmaceutical High blood 1S Perindopril Spring House, PA pressure erbumine
Neurontin C 23 Parke-Davis Epilepsy 1P Gabapentin Morris Plains, NJ
Lipidil C 24 Fournier Research Lowering serum 1S Fenofibrate Mamaroneck, NY triglycerides
Lescol C 25 Sandoz Pharmaceuticals Lowering serum 1S Fluvastatin sodium East Hanover, NJ cholesterol
These figures are in accordance with previously used reporting methods for generic drugs where applications for the same drug product from a single manufacturer but in different strength were counted as separate approvals. The word "distinct" is used to refer to groups of products where all strengths are counted as one.
Dosage T = Tablets C = Capsules I = Injection forms: O = Ointment H = Ophthalmic solution L = Liquid for oral use
1 --- Drug that is a new molecular entity. 4 --- Drug that is a new combination of ingredients. P --- Priority review: a drug offering a therapeutic advance. S --- Standard review: a drug substantially equivalent to a previously marketed drug. AA -- Drug indicated for treatment of AIDS or HIV-related disease. E --- Drug for severly debilitating or life threatening illness. O --- Product designated as an orphan drug.
The numbers of NMEs approved in previous years are: 1992: 26, 1991: 30, 1990: 23, 1989: 23, 1988: 20, 1987: 21, 1986: 20, 1985: 30, 1984: 22, 1983: 14, 1982: 28, 1981: 27, 1980: 12.
The important biological product approvals by FDA's Center for Biologics Evaluation and Research during 1993 are:
PRODUCT NAME (S) MANUFACTURER INDICATIONS/USE
Kogenate 1 Miles Inc. Hemophilia A T Antihemophilic Factor Berkeley, CA O (Recombinant)
ActHIB 2 Pasteur Merieux Immunization V Haemophilus b Serums et Vacc. S.A. of infants Conjugate Lyon, France & children (Tetanus Toxoid Conjugate)
ActHIB 3 Pasteur Merieux (Form for use V Haemophilus b Serums et Vacc. S.A. with Connaught S Conjugate Lyon, France DTP vaccine) (Tetanus Toxoid Conjugate)
Tetramune 4 Lederle Labs. DTP and V Diphtheria & Tetanus Pearl River, NY haemophilus Toxoids & Pertussis immunization Vaccine Adsorbed & Haemophilus b Conjugate (Diphtheria CRM197 Protein Conjugate
Hepatitis C 5 Chiron Corp. Test for anti- D Virus Encoded Emeryville,, CA bodies to Antigen hepatitis C (Recombinant) (RIBA) virus
Betaseron 6 Chiron Corp. Multiple T Interferon Emeryville, CA Sclerosis O beta-1b
Pulmozyme 7 Genentech Inc. Cystic T Dornase alfa San Francisco, CA Fibrosis O
Standardized Cat 8 Meridian Bio-Medical Diagnosis and A Hair Round Rock, TX treatment of S allergies to cats
Epogen 9 Amgen Inc. Anemia T Epoetin alfa Thousand Oaks, CA associated S with cancer chemotherapy
Epogen 10 Amgen Inc. (Multidose T Epoetin alfa Thousand Oaks, CA formulation) S
Orthoclone OKT3 11 Ortho Biotech Inc. Rejection of T Muromonab-CD3 Raritan, NJ liver & heart transplants
Gamimune-N 12 Miles Inc. Preventing T Immune Globulin Berkeley, CA infections in S Intravenous (Human) bone marrow transplant patients
Gamimune-N 13 Miles Inc. Preventing T Immune Globulin Berkeley, CA infections in S Intravenous (Human) children with HIV
Intron A 14 Schering Corp. Use in comb- T Interferon alfa-2a Kenilworth, NJ ination with S podophyllin in treating genital warts
Intron A 15 Schering Corp. (Injectable T Interferon alfa-2a Kenilworth, NJ form) S
Engerix-B 16 SmithKline Beecham New dosage V Hepatitis B Rixensart, Belgium form S vaccine (Recombinant)
Recombivax HB 17 Merck Sharp & Dohme New dosage V Hepatitis B Vaccine West Point, PA form S (Recombinant)
Albumin (Human) 4% 18 New York Blood Cent. New dosage T Melville, NY form S
Albumin (Human) 20% 19 New York Blood Cent. New dosage T Melville, NY form S
Qwick-1 Microwave 20 Microwave Med Syst. Warming 5 Blood & Plasma Littleton, MA blood Warmer
Anti-B27 FITC 21 One Lambda Inc. Tissue 5 Monoclonal Antibody Canoga Park, CA typing
Radiation Exposure 22 International Spec. Measuring 5 Indicators for Products exposure of Irradiated Blood Wayne, NJ blood to irradiation
Cryogenic Storage 23 CharterMed Storage of 5 Container using Lakewood, NJ blood Hemoflex Film
V -- Vaccine products A -- Allergenic products D -- Diagnostic products T -- Therapeutic products 5 -- Biological devices subject to 510K medical device review procedures O -- Orphan products
The numbers of important new biological products approved in previous years are: 1992: 16, 1991: 16, 1990: 14. 1989: 14, 1988: 6, 1987: 6, 1986: 6.
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SOURCE: Food and Drug Administration (FDA).
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