[Federal Register Volume 80, Number 242 (Thursday, December 17, 2015)]
[Notices]
[Pages 78747-78748]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-31689]
[[Page 78747]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-4667]
Determination That Vancomycin Hydrochloride Injection Drug
Products, Were Not Withdrawn From Sale for Reasons of Safety or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 or Agency) has
determined that VANCOCIN (vancomycin hydrochloride (HCl)) injection,
500 milligrams (mg)/vial, 1 gram (g)/vial, 10 g/vial (``the VANCOCIN
drug products''); VANCOLED (vancomycin HCl) injection, 500 mg/vial, 1
g/vial, 2 g/vial, 5 g/vial, and 10 g/vial (``the VANCOLED drug
products''); and VANCOCIN HYDROCHLORIDE (vancomycin HCl) injection, 500
mg/vial and 1 g/vial (``the VANCOCIN HCl drug products'') (hereinafter
collectively ``these Vancomycin HCl drug products''), were not
withdrawn from sale for reasons of safety or effectiveness. This
determination will allow FDA to approve abbreviated new drug
applications (ANDAs) for these Vancomycin HCl drug products if all
other legal and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Robin Fastenau, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002, 240-
402-4510, [email protected].
SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products 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 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 known generally as the ``Orange
Book.'' Under FDA regulations, drugs are removed 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).
A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale,
but must be made prior to approving an ANDA that refers to the listed
drug (Sec. 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that
does not refer to a listed drug.
The VANCOCIN drug products are the subject of ANDA 62-812 held by
ANI Pharmaceuticals, Inc., and were initially approved on November 17,
1987. The VANCOLED drug products are the subject of ANDA 62-682 held by
Eurohealth International S[agrave]rl and were initially approved on
July 22, 1986. The VANCOCIN HCl drug products are the subject of ANDA
60-180 held by ANI Pharmaceuticals, Inc., and were initially approved
on November 6, 1964. These Vancomycin HCl drug products are indicated
for the treatment of serious or severe infections caused by susceptible
strains of methicillin-resistant (beta-lactam-resistant) staphylococci.
They are indicated for penicillin-allergic patients; for patients who
cannot receive or who have failed to respond to other drugs, including
the penicillins or cephalosporins; and for infections caused by
vancomycin-susceptible organisms that are resistant to other
antimicrobial drugs. They are indicated for initial therapy when
methicillin-resistant staphylococci are suspected, but after
susceptibility data are available, therapy should be adjusted
accordingly.
These Vancomycin HCl drug products are currently listed in the
``Discontinued Drug Product List'' section of the Orange Book.
Strides Arcolab Limited submitted a citizen petition dated May 18,
2009 (Docket No. FDA-2009-P-0242), under Sec. 10.30 (21 CFR 10.30),
requesting that the Agency determine whether VANCOCIN (Vancomycin HCl)
injection, 10 g/vial, was withdrawn from sale for reasons of safety or
effectiveness. Although the citizen petition did not address the 500
mg/vial and 1 g/vial strengths, these strengths have also been
discontinued. On our own initiative, we have also determined whether
these strengths were withdrawn for safety or effectiveness reasons.
Hospira submitted a citizen petition dated October 5, 2015 (Docket No.
FDA-2015-P-3621), under Sec. 10.30, requesting that the Agency
determine whether VANCOLED (vancomycin HCl) injection, 10 g bulk
packaging, was withdrawn from sale for reasons of safety or
effectiveness. Although the citizen petition did not address the 500
mg/vial, 1 g/vial, 2 g/vial, and 5 g/vial strengths, these strengths
have also been discontinued. On our own initiative, we have also
determined whether these strengths were withdrawn from sale for reasons
of safety or effectiveness. In addition, the VANCOCIN HCl (Vancomycin
HCl), injection, 500 mg/vial, and 1 g/vial drug products have been
discontinued from sale and FDA has determined whether these drug
products were withdrawn from the market for safety or effectiveness
reasons.
After considering the citizen petitions and reviewing Agency
records and based on the information we have at this time, FDA has
determined under Sec. 314.161 that these Vancomycin HCl drug products
were not withdrawn for reasons of safety or effectiveness. The
petitioners have identified no data or other information suggesting
that these Vancomycin HCl drug products were withdrawn for reasons of
safety or effectiveness. We have carefully reviewed our files for
records concerning the withdrawal of these Vancomycin HCl drug products
from sale. We have also independently evaluated relevant literature and
data for possible postmarketing adverse events. We have reviewed the
available evidence and determined that these drug products were not
withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list these Vancomycin HCl
drug products 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
these Vancomycin HCl drug products may be approved by the Agency as
long as they meet all other legal and regulatory requirements for the
approval of ANDAs. If FDA determines that labeling for these drug
products should be revised to meet current standards, the Agency will
[[Page 78748]]
advise ANDA applicants to submit such labeling.
Dated: December 11, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-31689 Filed 12-16-15; 8:45 am]
BILLING CODE 4164-01-P