U.S. Food and Drug Administration • Center for Drug Evaluation and Research
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Approval Statistics


Calculations are based on best available information and may be subject to revision.

Approved claims per year

Year Number
1
1949 1
1952 1
1953 2
1954 1
1957 1
1959 5
1961 1
1962 2
1963 7
1964 5
1965 1
1966 2
1967 1
1969 3
1970 4
1971 3
1973 2
1974 2
1975 1
1976 1
1977 2
1978 3
1981 1
1982 1
1983 1
1986 5
1987 7
1988 7
1989 2
1990 6
1991 6
1992 4
1993 4
1994 6
1995 10
1996 16
1997 9
1998 21
1999 18
2000 8
2001 7
2002 23
2003 11
2004 16
2005 11
2006 28
2007 10
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Approved New Molecules for Cancer Use per year

Year Number
1952 1
1953 2
1954 1
1957 1
1959 3
1962 1
1963 7
1964 3
1965 1
1966 1
1967 1
1969 2
1970 1
1971 1
1973 1
1974 1
1975 1
1976 1
1977 2
1978 2
1981 1
1983 1
1986 1
1987 2
1989 1
1990 1
1991 2
1992 3
1993 1
1994 1
1995 4
1996 9
1997 3
1998 6
1999 8
2000 2
2001 2
2002 5
2003 1
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Classes of drugs for approved claims

Description Number
alfa interferon 6
alkylator 11
anthracycline 10
antibiotic 7
aromatase inhibitor 4
covalent conjugate of recombinant methionyl human GCSF and monomethoxypolyethylene glycol 1
cyclo-oxygenase inhibitor 1
diluent 1
enzyme 1
erythropoiesis stimulating protein 2
estrogen receptor modulator 9
folate antagonist 5
granulocyte colony stimulating factor 2
hormonal 1
inorganic arsenate 1
microtubule inhibitor 22
modifier 3
monoclonal antibody 4
monoclonal antivody 4
nitrosourea 5
nucleoside analogue 17
osteoclast inhibitor 1
platinum 6
retinoid 4
stem cell stimulator 1
topoisomerase 1 inhibitor 5
topoisomerase 2 inhibitor 7
tyrosine kinase inhibitor 2
urate-oxidase enzyme 1

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Indications for approved claims

Description Number
adrenal 2
bladder 1
bone 1
bone marrow 7
brain and central nervous system 2
breast 30
chemoprotectant 5
colon-rectum 8
diluent 1
esophagus 1
eye 1
gastro intestinal 2
gynecologic (other than cervix, ovary) 1
Kaposi's sarcoma- AIDS related 6
kidney 3
leukemias 26
lung 14
lymphoma 15
muscle 1
osteosarcoma 1
ovary 12
pancreas 2
pleural effusion 2
prostate 4
radiation protectant 1
severe combined immunodeficiency 1
Sickle cell anemia 1
skin 1
skin-melanoma 1
soft tissue sarcoma 1
stomach and gastrointestinal 1
testis 7
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Line of therapy for approved claims

Description Number
Adjuvant 9
Chemoprotection 7
Diluent 1
dosage change 1
First 37
First, Second 2
Palliative 19
Risk reduction 2
Second 28
Second and subsequent 5
Second, Third 3
supportive 7
Third 3
Topical treatment 1
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Dosage Forms for approved claims

Description Number
aerosol 1
capsule 11
capsule; oral 1
capsules; oral 1
gel 2
implant 2
intramuscular injection 8
intrathecal injection 1
intravenous injection 137
intravesical instillation 1
ntravenous injection 3
powder for injection 1
subcutaneous injection 8
tablet 23
tablet; buccal 1
tablet; oral 4
VIAL; SUBCUTANEOUS 1
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Approved claims with Special Status

Description Number
Orphan Status 102
Priority Status 47
Subpart H Status 32
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FDA/Center for Drug Evaluation and Research
Last Updated:  
Originator: OTCOM/DLIS
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