[Federal Register Volume 68, Number 17 (Monday, January 27, 2003)]
[Notices]
[Pages 3886-3887]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-1742]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02P-0068]


Determination That Chymopapain 10,000 Units/Vial Injection Was 
Not Withdrawn From Sale for Reasons of Safety or Effectiveness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) is announcing its 
determination that CHYMODIACTIN (chymopapain 10,000 units/vial 
injection) was not withdrawn from sale for reasons of safety or 
effectiveness. This determination will allow FDA to

[[Page 3887]]

approve abbreviated new drug applications (ANDAs) for chymopapain 
10,000 units/vial injection.

FOR FURTHER INFORMATION CONTACT: Brian L. Pendleton, 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 drugs 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 Under FDA regulations, drugs are withdrawn from the list if the 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).
    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.
    CHYMODIACTIN (chymopapain 10,000 units/vial injection) is the 
subject of NDA 18-663. CHYMODIACTIN is indicated for the treatment of 
patients with documented herniated lumbar intervertebral discs whose 
symptoms and signs, particularly sciatica, have not responded to an 
adequate period or periods of conservative therapy. FDA approved the 
NDA for CHYMODIACTIN on November 10, 1982.
    On February 12, 2002, ChymoCorp submitted a citizen petition 
(Docket No. 02P-0068/CP1) under 21 CFR 10.30 requesting that the agency 
determine whether chymopapain manufactured by Abbott Laboratories under 
the brand name CHYMODIACTIN was withdrawn from sale for reasons of 
safety or effectiveness.
    The agency has determined that CHYMODIACTIN (chymopapain 10,000 
units/vial injection) was not withdrawn from sale for reasons of safety 
or effectiveness. Abbott Laboratories informed the agency by telephone 
that the company no longer markets CHYMODIACTIN. FDA has independently 
evaluated relevant literature and data for possible postmarketing 
adverse event reports, but has found no information that would indicate 
this product was withdrawn for reasons of safety or effectiveness.
    After considering the citizen petition and reviewing its records, 
FDA determines that, for the reasons outlined previously, CHYMODIACTIN 
(chymopapain 10,000 units/vial injection) was not withdrawn from sale 
for reasons of safety or effectiveness. Accordingly, the agency will 
continue to list chymopapain 10,000 units/vial injection 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 CHYMODIACTIN 
(chymopapain 10,000 units/vial injection) may be approved by the 
agency.

    Dated: January 15, 2003.
Margaret M. Dotzel,
Assistant Commissioner for Policy.
[FR Doc. 03-1742 Filed 1-24-03; 8:45 am]
BILLING CODE 4160-01-S