[Federal Register Volume 64, Number 162 (Monday, August 23, 1999)]
[Notices]
[Page 45973]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-21813]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99N-2532]


Determination That Astemizole 10-Milligram Tablets Were Withdrawn 
From Sale for Safety Reasons

AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined that 
astemizole 10-milligram (mg) tablets (Hismanal) were withdrawn from 
sale for safety reasons. The agency will not accept or approve 
abbreviated new drug applications (ANDA's) for astemizole 10-mg 
tablets.

FOR FURTHER INFORMATION CONTACT: Andrea C. Masciale, 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 (Public Law 98-417) 
(the 1984 amendments), which authorized the approval of duplicate 
versions of approved innovator drug products under an ANDA procedure. 
ANDA sponsors generally must 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 a drug that 
was previously approved under a new drug application (NDA). Sponsors of 
ANDA's are not required to repeat the extensive clinical testing 
necessary to gain approval of an NDA. The only data from investigations 
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 Under FDA regulations, drugs are withdrawn from the list if the 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drug was withdrawn from sale for reasons of safety or effectiveness 
(Sec. 314.162 (21 CFR 314.162)). FDA may not approve an ANDA that does 
not refer to a listed drug (21 CFR 314.92(a)).
    Astemizole 10-mg tablets (Hismanal) are the subject of approved NDA 
19-402, currently held by Janssen Pharmaceutica (Janssen). In 1988, FDA 
approved the NDA for Hismanal tablets for the relief of symptoms 
associated with seasonal allergic rhinitis and chronic idiopathic 
urticaria. On June 18, 1999, Janssen withdrew Hismanal tablets from 
sale in the United States. The agency's review of the withdrawal of 
astemizole 10-mg tablets (Hismanal) from the market has considered the 
sponsor's explanation of the basis for the withdrawal of the product 
and information available to the agency regarding Hismanal. The current 
evidence supports the conclusion under Sec. 314.161 (21 CFR 314.161) 
that astemizole 10-mg tablets (Hismanal) were withdrawn from the market 
for safety reasons.
    The agency has determined, under Sec. 314.161, that astemizole 10-
mg tablets (Hismanal) were withdrawn from the market for safety 
reasons. Accordingly, the agency will remove astemizole 10-mg tablets 
(Hismanal) from the ``Orange Book'' (Sec. 314.162). FDA will not accept 
or approve ANDA's that refer to this drug product.

    Dated: August 13, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-21813 Filed 8-20-99; 8:45 am]
BILLING CODE 4160-01-F