[Federal Register Volume 62, Number 209 (Wednesday, October 29, 1997)]
[Notices]
[Pages 56193-56194]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-28672]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97P-0220]


Determination That Pseudoephedrine Hydrochloride 120-Milligram 
Extended-Release Capsules Over-the-Counter Were Not Withdrawn From Sale 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 
pseudoephedrine hydrochloride (Sudafed 12-Hour Capsules) 120-milligram 
(mg) extended-release capsules over-the-counter (OTC) were not 
withdrawn from sale for reasons of safety or effectiveness. This 
determination will allow FDA to approve abbreviated new drug 
applications (ANDA's) for pseudoephedrine hydrochloride 120-mg 
extended-release capsules.

FOR FURTHER INFORMATION CONTACT: Mary E. 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 (Pub. L. 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 ANDA's 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 
drug.
    The 1984 amendments included what is now section 505(j)(6) of the 
Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(j)(6)), 
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 Under FDA regulations, drugs are withdrawn from the 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)). Regulations also provide 
that the agency must make a determination as to 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 
(Sec. 314.161(a)(1) (21 CFR 314.161(a)(1))). FDA may not approve an 
ANDA that does not refer to a listed drug.
    In a citizen petition dated June 3, 1997, and an amendment dated 
June 24, 1997 (Docket Nos. 97P-0220/CP1 and 97P-0220/AMD1), submitted 
under 21 CFR 10.30 and 314.161(a)(3), Eurand America, Inc., requested 
that the agency determine whether pseudoephedrine hydrochloride 120-mg 
extended-release capsules (OTC) were withdrawn from sale for reasons of 
safety or effectiveness. Pseudoephedrine hydrochloride 120-mg extended-
release capsules, OTC (Sudafed 12-Hour Capsules) were the subject of 
approved NDA 17-941 held by Burroughs Wellcome Co. Burroughs Wellcome

[[Page 56194]]

notified FDA in writing that Sudafed 12-Hour Capsules (pseudoephedrine 
hydrochloride 120-mg extended-release capsules, OTC) were no longer 
being marketed under NDA 17-941 and requested that approval of the 
application be withdrawn. In the Federal Register of September 29, 1995 
(60 FR 50626), FDA withdrew approval of NDA 17-941.
    FDA has reviewed its records and, under Secs. 314.161 and 
314.162(c), has determined that pseudoephedrine hydrochloride 120-mg 
extended-release capsules (OTC) were not withdrawn from sale for 
reasons of safety or effectiveness. Accordingly, the agency will 
maintain pseudoephedrine hydrochloride 120-mg extended-release capsules 
(OTC) 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. ANDA's that refer to 
pseudoephedrine hydrochloride 120-mg extended-release capsules (OTC) 
may be approved by the agency.

    Dated: October 23, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-28672 Filed 10-28-97; 8:45 am]
BILLING CODE 4160-01-F