[Federal Register Volume 72, Number 152 (Wednesday, August 8, 2007)]
[Notices]
[Pages 44558-44559]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-15488]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006P-0445]


Determination That MIVACRON (Mivacurium Chloride) Injection 
Equivalent to 2 Milligrams Base/Milliliter Was Not Withdrawn From Sale 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) has determined that 
MIVACRON (mivacurium chloride) injection equivalent to (EQ) 2 
milligrams (mg) base/milliliter (mL) was not withdrawn from sale for 
reasons of safety or effectiveness. This determination will allow FDA 
to approve abbreviated new drug applications (ANDAs) for mivacurium 
chloride injection EQ 2 mg base/mL.

FOR FURTHER INFORMATION CONTACT: Christine F. Rogers, 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 
applicants 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. ANDA applicants 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 (the 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 removed from the list 
if the agency withdraws or suspends approval

[[Page 44559]]

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.
    MIVACRON (mivacurium chloride) injection EQ 2 mg base/mL is the 
subject of approved NDA 20-098 held by Abbott Laboratories, Inc. 
(Abbott). MIVACRON is a short-acting neuromuscular blocking agent 
indicated for inpatients and outpatients, as an adjunct to general 
anesthesia, to facilitate tracheal intubation and to provide skeletal 
muscle relaxation during surgery or mechanical ventilation. FDA 
approved the NDA for MIVACRON on January 22, 1992. Abbott ceased 
marketing MIVACRON in July 2006.
    Regulus Pharmaceutical Consulting, Inc., submitted a citizen 
petition dated October 25, 2006 (Docket No. 2006P-0445/CP1), under 21 
CFR 10.30, requesting that the agency determine, as described in Sec.  
314.161, whether MIVACRON (mivacurium chloride) injection EQ 2 mg base/
mL was withdrawn from sale for reasons of safety or effectiveness. The 
petitioner has identified no data or other information suggesting that 
MIVACRON was withdrawn from sale as a result of safety or effectiveness 
concerns.
    We have reviewed our records and determined that Abbott's MIVACRON 
(mivacurium chloride) injection EQ 2 mg base/mL was not withdrawn from 
sale for reasons of safety or effectiveness. We have also independently 
evaluated relevant literature and data for adverse event reports and 
have determined that this product was not withdrawn for reasons of 
safety or effectiveness.
    After considering the citizen petition and reviewing its records, 
FDA has determined that, for the reasons outlined in this notice, 
Abbott's MIVACRON (mivacurium chloride) injection EQ 2 mg base/mL was 
not withdrawn from sale for reasons of safety or effectiveness. 
Accordingly, the agency will list MIVACRON (mivacurium chloride) 
injection EQ 2 mg base/mL 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 MIVACRON (mivacurium chloride) 
injection EQ 2 mg base/mL may be approved by the agency as long as they 
meet all relevant legal and regulatory requirements for the approval of 
ANDAs. If FDA determines that labeling for this drug product should be 
revised to meet current standards, the agency will advise ANDA 
applicants to submit such labeling.

    Dated: July 30, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7-15488 Filed 8-7-07; 8:45 am]
BILLING CODE 4160-01-S