[Federal Register: August 4, 2004 (Volume 69, Number 149)]
[Notices]
[Page 47155-47156]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04au04-78]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N-0331]
Determination That Esmolol Hydrochloride Injection and Ketorolac
Tromethamine Injection Were Not Withdrawn From Sale for Reasons of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
the two drug products listed in this document were not withdrawn from
sale for reasons of safety or effectiveness. This determination means
that FDA will not begin procedures to withdraw approval of abbreviated
new drug applications (ANDAs) for the drug products, and it will allow
FDA to continue to approve ANDAs for the products.
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. Sponsors of ANDAs do
not have to repeat the extensive clinical testing otherwise necessary
to gain approval of a new drug application (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 Under FDA regulations, drugs are withdrawn from the list if the
[[Page 47156]]
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)).
Under Sec. 314.161(a) (21 CFR 314.161(a)), the agency must
determine whether a listed drug was withdrawn from sale for reasons of
safety or effectiveness: (1) Before an ANDA that refers to that listed
drug may be approved or (2) whenever a listed drug is voluntarily
withdrawn from sale, and ANDAs that referred to the listed drug have
been approved. Section 314.161(d) provides that if FDA determines that
the listed drug was removed from sale for safety or effectiveness
reasons, the agency will initiate proceedings that could result in the
withdrawal of approval of the ANDAs that refer to the listed drug.
FDA has become aware that the drug products listed in table 1 of
this document have been withdrawn from sale.
Table 1.
------------------------------------------------------------------------
Application No. Drug Applicant
------------------------------------------------------------------------
19-386 BREVIBLOC (esmolol Baxter Healthcare
HCl) Injection, 10 Corp., Route 120 and
milligram (mg)/ Wilson Rd., RLT-10,
milliliter (mL) Round Lake, IL 60073-
(formulation without 0490
sodium chloride)
------------------------------------------------------------------------
19-698 TORADOL IV/IM Roche Pharmaceuticals,
(ketorolac 340 Kingsland St.,
tromethamine Nutley, NJ 07110-1199
injection), 15 mg/mL
and 30 mg/mL
(formulations with
and without citric
acid)
------------------------------------------------------------------------
FDA has reviewed our records and, under Sec. 314.161, has
determined that the drug products listed in this document were not
withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the agency will continue to list these drug products in
the ``Discontinued Drug Product List'' section of the Orange Book. The
``Discontinued Drug Product List'' identifies, among other items, drug
products that have been discontinued from marketing for reasons other
than safety or effectiveness. Approved ANDAs that refer to the NDAs
listed in this document are unaffected by the withdrawal of the
products subject to those NDAs. Additional ANDAs for the products may
also be approved by the agency.
Dated: July 27, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-17692 Filed 8-3-04; 8:45 am]
BILLING CODE 4160-01-S