[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]



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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Products, Were Not Withdrawn From Sale for Reasons of Safety or 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withdrawn from sale for reasons of safety or effectiveness.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