[Federal Register: August 4, 2004 (Volume 69, Number 149)]
[Page 47155-47156]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



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Tromethamine Injection Were Not Withdrawn From Sale for Reasons of 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the two drug products listed in this document were not withdrawn from 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 Under FDA regulations, drugs are withdrawn from the list if the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listed drug was withdrawn from sale for reasons of safety or 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

    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]