[Federal Register Volume 70, Number 248 (Wednesday, December 28, 2005)]
[Notices]
[Page 76851]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E5-7875]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005P-0244]


Determination That DECADRON (Dexamethasone) Tablets, 1.5 
Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or 
Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined that 
DECADRON (dexamethasone) tablets, 1.5 milligrams (mg), were not 
withdrawn from sale for reasons of safety or effectiveness. This 
determination will allow FDA to approve abbreviated new drug 
applications (ANDAs) for dexamethasone tablets, 1.5 mg.

FOR FURTHER INFORMATION CONTACT: Janice L. Weiner, Center for Drug 
Evaluation and Research (HFD-7), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-2041.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price 
Competition and Patent Term Restoration Act of 1984 (the 1984 
amendments) (Public Law 98-417), which authorized the approval of 
duplicate versions of drug products approved under an ANDA procedure. 
ANDA sponsors must, with certain exceptions, show that the drug for 
which they are seeking approval contains the same active ingredient in 
the same strength and dosage form as the ``listed drug,'' which is 
typically a version of the drug that was previously approved. Sponsors 
of ANDAs do not have to repeat the extensive clinical testing otherwise 
necessary to gain approval of a new drug application (NDA). The only 
clinical data required in an ANDA are data to show that the drug that 
is the subject of the ANDA is bioequivalent to the listed drug.
    The 1984 amendments include what is now section 505(j)(7) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which 
requires FDA to publish a list of all approved drugs. FDA publishes 
this list as part of the ``Approved Drug Products With Therapeutic 
Equivalence Evaluations,'' which is generally known as the ``Orange 
Book.'' Under FDA regulations, drugs are withdrawn from the list if the 
agency withdraws or suspends approval of the drug's NDA or ANDA for 
reasons of safety or effectiveness or if FDA determines that the listed 
drug was withdrawn from sale for reasons of safety or effectiveness (21 
CFR 314.162).
    Under 21 CFR 314.161(a)(1), the agency must determine whether a 
listed drug was withdrawn from sale for reasons of safety or 
effectiveness before an ANDA that refers to that listed drug may be 
approved. FDA may not approve an ANDA that does not refer to a listed 
drug.
    DECADRON (dexamethasone) tablets, 1.5 mg, are the subject of 
approved NDA 11-664 held by Merck & Co., Inc. (Merck). According to 
Merck's 1997 annual report, the 1.5-mg dose strength, among others, of 
DECADRON (dexamethasone) tablets, a synthetic adrenocortical steroid, 
was discontinued in 1997. In a citizen petition dated June 16, 2005 
(Docket No. 2005P-0244), submitted under 21 CFR 10.30, ECR 
Pharmaceuticals requested that the agency determine whether DECADRON 
(dexamethasone) tablets, 1.5 mg, were withdrawn from sale for reasons 
of safety or effectiveness.
    The agency has determined that Merck's DECADRON (dexamethasone) 
tablets, 1.5 mg, were not withdrawn from sale for reasons of safety or 
effectiveness. FDA has reviewed its files for records concerning the 
withdrawal of DECADRON (dexamethasone) tablets, 1.5 mg, from sale. 
There is no indication that the decision not to market DECADRON 
(dexamethasone) tablets, 1.5 mg, commercially is a function of safety 
or effectiveness concerns. FDA has independently evaluated relevant 
literature and data for possible concerns regarding the safety or 
effectiveness of this drug product. FDA has found no information that 
would indicate that this product was withdrawn for reasons of safety or 
effectiveness.
    After considering the citizen petition and reviewing agency 
records, FDA determines that for the reasons outlined previously, 
DECADRON (dexamethasone) tablets, 1.5 mg, were not withdrawn from sale 
for reasons of safety or effectiveness. Accordingly, the agency will 
continue to list DECADRON (dexamethasone) tablets, 1.5 mg, in the 
``Discontinued Drug Product List'' section of the Orange Book. The 
``Discontinued Drug Product List'' delineates, among other items, drug 
products that have been discontinued from marketing for reasons other 
than safety or effectiveness. ANDAs for dexamethasone tablets, 1.5 mg, 
that comply with relevant legal and regulatory requirements may be 
approved by the agency.

    Dated: December 19, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E5-7875 Filed 12-27-05; 8:45 am]
BILLING CODE 4160-01-S