[Federal Register: August 8, 2007 (Volume 72, Number 152)]
[Notices]
[Page 44558-44559]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08au07-87]
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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Equivalent to 2 Milligrams Base/Milliliter Was Not Withdrawn From Sale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.
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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milligrams (mg) base/milliliter (mL) was not withdrawn from sale for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