[Federal Register: May 28, 2003 (Volume 68, Number 102)]
[Page 31720]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 02P-0479]

Determination That Periactin Was Not Withdrawn From Sale for 
Reasons of Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) has determined that 
Periactin (cyproheptadine hydrochloride (HCl)) 4-milligram (mg) tablets 
were not withdrawn from sale for reasons of safety or effectiveness. 
This determination will allow FDA to approve abbreviated new drug 
applications (ANDAs) for cyproheptadine HCl 4-mg tablets.

FOR FURTHER INFORMATION CONTACT: Mary Catchings, 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 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 a 
version of the drug that was previously approved under a new drug 
application (NDA). Sponsors of ANDAs do not have to repeat the 
extensive clinical testing otherwise necessary to gain approval of an 
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 
    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 Under FDA regulations, drugs are withdrawn from the list if the 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listed drug was withdrawn from sale for reasons of safety or 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 Sec.  314.161(a)(1) (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withdrawn from sale for reasons of safety or effectiveness before an 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.
    Periactin 4-mg tablets are the subject of NDA 12-649. On October 
17, 1961, Merck & Co., Inc., received approval to market Periactin 4-mg 
    On November 5, 2002, CorePharma LLC submitted a citizen petition 
(Docket No. 02P-0479/CP1) under 21 CFR 10.30 requesting that the agency 
assign reference listed drug status to a currently marketed 
cyproheptadine hydrochloride 4-mg tablet drug product. At that time, 
FDA exercised its discretion under Sec.  314.161(a) to determine if 
Periactin 4-mg tablets were withdrawn for reasons of safety or 
    After reviewing agency records, FDA has determined that Periactin 
4-mg tablets were not withdrawn from sale for reasons of safety or 
effectiveness. Accordingly, the agency will continue to list Periactin 
4-mg tablets 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 that refer to 
Periactin 4-mg tablets may be approved by the agency.

    Dated: May 19, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-13193 Filed 5-27-03; 8:45 am]