ROCKVILLE, Md., Jan. 15 /PRNewswire/ -- FDA's Center for Drug Evaluation
and Research (CDER) in 1998 took 199 actions on original new drug applications
(NDAs) and approved 90 of them. The median total time to approval for new
original drugs was 12.0 months, 17 percent shorter than the 14.4 months in
1997. The median CDER review time for these products was also 12.0 months, 2
percent shorter than the year before.
The 1998 cohort included 25 priority drugs considered of potentially
exceptional public health value. The median approval time for these priority
products was 6.4 months. Thirty of the new original drugs were new molecular
entities (NMEs), which contain an active substance that had never before been
approved for marketing in any form in the United States. The median approval
time for these products was 12.0 months, 10 percent faster than the 13.4
months in 1997.
Sixteen of the NMEs were priority drugs, which received an accelerated
review because they represent a major advance in medical treatment. The
following priority drugs were approved in six months or less: efavirenz (3.2
months), fomivirsen (4.6), sildenafil (5.9), capecitabine (6.0), rifapentine
(6.0), and leflunomide (6.0).
CDER last year scored an important achievement also in approving generic
drugs, which are not user fee supported. CDER's Office of Generic Drugs
received an unusually high number of applications -- 564, v. 322 in 1994 --
and approved 344 of them. The approvals included cyclosporin, used to prevent
rejection of transplanted organs, and generic versions of cimetadine for the
treatment of ulcers, and a nicotine transdermal product for use as a smoking
deterrent. Despite the continuous increase in submissions, the median approval
time for generic drugs has decreased from 28.2 months in 1995 to 18.7 months
last year.
In addition to the medicines included in FDA's report on New Health Care
Products Approved in 1998, CDER approved the following "orphan" products with
patient populations of 200,000 or less:
* Sacrosidase, the first treatment for patients with generic deficiency
of the enzyme sucrase, which is part of the congenital sucrase-
isomaltase deficiency (CSID).
* Lepirudin, which provides the first available treatment for patients
with heparin-induced markedly lowered platelet counts to help prevent
further development of platelet emboli.
* Octreotide acetate depot, a new dosage form for patients with
acromegaly, VIPoma, or carcinoid. This new dosage form reduces the
number of injections they require from 2-4 a day to one a month.
* Modafinil, a new therapy for patients with narcolepsy.
The complete list of CDER's approvals in 1998 for prescription
products follows:
Priority Approvals:
Lepirudin
Sildenafil citrate
Sacrosidase
Capecitabine
Tirofiban hydrochloride (2 dosage forms)
Eptifibatide
Ribavirin and interferon alfa-2b
Glucagon (rDNA)
Rifapentine
Thalidomide
Fomivirsen sodium
Levonorgestrel/ethinyl estradiol
Leflunomide
Glucagon rDNA origin
Nevirapine
Kit for the preparation of tc 99mm apcitide
Efavirenz
Valrubicin
Midazolam HCL
Octreotide acetate depot
Thyrotropin alfa
Abacavir sulfate (2 dosage forms)
Celecoxib
NMEs:
Tolcapone
Naratriptan
Montelukast sodium
Lepirudin
Loteprednol etabonate
Tolterodine tartrate
Risedronate sodium
Sildenafil citrate
Brinzolamide
Sacrosidase
Paricalcitol
Capecitabine
Tirofiban hydrochloride
Eptifibatine
Candesartam cilexetil
Rifapentine
Rizatriptan benzoate
Thalidomide
Citalopram hydrobromide
Fomivirsen sodium
Leflunomide
Kit for the preparation of tc 99mm apcitide
Efavirenz
Valrubicin
Sevelarmer hydrochloride
Telmisartan
Thyrotropin alfa
Abacavir sulfate
Celecoxib.
SOURCE Food and Drug Administration
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