[Federal Register Volume 66, Number 135 (Friday, July 13, 2001)]
[Notices]
[Page 36793]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-17496]



[[Page 36793]]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00P-1548]


Determination That Cyclosporine Capsules USP, 50 Milligrams, Were 
Not Withdrawn From Sale for Reasons of Safety or Effectiveness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 
cyclosporine capsules USP (Neoral Soft Gelatin Capsules), 50 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(mg), were not withdrawn from sale for reasons of safety or 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 cyclosporine capsules USP, 50 mg.

FOR FURTHER INFORMATION CONTACT: Paul C. Varki, Center for Drug 
Evaluation and Research (HFD-7), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20855, 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 
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 Under FDA regulations, drugs are withdrawn from the list if the 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).
    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.
    Cyclosporine capsules USP, 50 mg, are the subject of NDA 50-715. On 
July 14, 1995, Sandoz, Inc. (now Novartis), obtained approval to market 
the 25-, 50-, and 100-mg capsules. Novartis has never marketed the 50-
mg capsules.
    On September 29, 2000, Lachman Consultant Services, Inc., submitted 
a citizen petition (Docket No. 00P-1548/CP1) under 21 CFR 10.30 to FDA 
requesting that the agency determine whether cyclosporine capsules USP, 
50 mg, were withdrawn from sale for reasons of safety or effectiveness. 
FDA has determined that, for purposes of Sec.  314.161(a) and (c), 
never marketing an approved drug product is equivalent to withdrawing 
the drug from sale.
    FDA has reviewed its records and, under Sec. 314.161, has 
determined that Novartis' decision not to market cyclosporine capsules 
USP, 50 mg, was not due to concerns about safety or effectiveness of 
the product. Accordingly, the agency will maintain cyclosporine 
capsules USP, 50 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 that 
refer to cyclosporine capsules USP, 50 mg, may be approved by the 
agency.

    Dated: July 6, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-17496 Filed 7-12-01; 8:45 am]
BILLING CODE 4160-01-S