News
01/13/1994
FDA DRUG AND BIOLOGICS APPROVALS -- 1993
NOTE TO CORRESPONDENTS Mike Shaffer
Jan. 13, 1994 (301) 443-3285
FDA approved 370 new drug, generic drug and biological product
applications in 1993. Seventy of the approvals were for new drugs,
51 were for biological products and 249 were for generic versions
of new drugs.
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
-MORE-
Page 2, NTC, 93 Approvals
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
-MORE-
Page 3, NTC, 93 Approvals
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.
-MORE-
Page 4, NTC, 93 Approvals
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
-MORE-
Page 5, NTC, 93 Approvals
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
-MORE-
Page 6, NTC, 93 Approvals
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.
-MORE-
Page 7, NTC, 93 Approvals
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
-MORE-
Page 8, NTC, 93 Approvals
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
-MORE-
Page 9, NTC, 93 Approvals
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.
####