[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]
-----------------------------------------------------------------------
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Not Withdrawn From Sale for Reasons of Safety or Effectiveness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.
-----------------------------------------------------------------------
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injection) was not withdrawn from sale for reasons of safety or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 Under FDA regulations, drugs are withdrawn from the list if the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