[Federal Register Volume 76, Number 12 (Wednesday, January 19, 2011)]
[Notices]
[Pages 3143-3144]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-1000]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-P-0431]


Determination That ALBAMYCIN (Novobiocin Sodium) Capsule, 250 
Milligrams, Was Withdrawn From Sale for Reasons of Safety or 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 
ALBAMYCIN (novobiocin sodium) capsule, 250 milligrams (mg) was 
withdrawn from sale for reasons of safety or effectiveness. The Agency 
will not accept or approve abbreviated new drug applications (ANDAs) 
for ALBAMYCIN (novobiocin sodium) capsule, 250 mg.

FOR FURTHER INFORMATION CONTACT: Nancy Hayes, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 6244, Silver Spring, MD 20993-0002, 301-
796-3601.

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 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 (FD&C 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

[[Page 3144]]

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.
    ALBAMYCIN (novobiocin sodium) capsule, 250 mg, is the subject of 
NDA 50-339, held by Pfizer, Inc. (Pfizer), and initially approved on 
September 4, 1964. ALBAMYCIN is indicated for the treatment of serious 
infections due to susceptible strains of Staphylococcus aureus when 
other less toxic antibiotics such as the penicillins, cephalosporins, 
vancomycin, lincomycin, erythromycin, and the tetracyclines cannot be 
used.
    Novobiocin antibiotic drug products were reviewed for efficacy 
under the Drug Efficacy Study Implementation (DESI) program. Under this 
program, implemented in response to the 1962 amendments to the FD&C Act 
requiring demonstration of effectiveness (The Kefauver-Harris 
Amendments, Public Law 87-781 (1962)), the National Academy of 
Sciences-National Research Council (NAS-NRC) undertook a study of some 
4,000 drug formulations to assess the efficacy of the products. Upon 
consideration of the findings and recommendations of the NAS-NRC, FDA 
set forth in the Federal Register its conclusions and assessment of 
whether and under what circumstances the reviewed drug products are 
considered ``effective'' for use as required by the FD&C Act.
    In the Federal Register of May 2, 1969 (34 FR 7252), FDA announced 
its conclusions following consideration of the findings and 
recommendations of the NAS-NRC regarding oral and parenteral forms of 
novobiocin including ALBAMYCIN (novobiocin sodium) capsule, 250 mg. The 
announcement stated that FDA had concluded that novobiocin is effective 
for certain indications and provided labeling guidelines in accordance 
with this conclusion. We note, however, that the initial panel review 
of a syrup form of novobiocin raised questions, even at that time, 
concerning the safety and effectiveness of this antibiotic. The panel 
report included the following statement: ``The development of safer and 
more effective drugs has virtually eliminated the need for novobiocin. 
The majority of the Panel believes that orally administered novobiocin 
should be taken off the market.'' Report of the Anti-Infectives Panel, 
National Academy of Sciences-National Research Council, Albamycin 
Syrup.
    In an annual report received on June 9, 1999, Pharmacia & Upjohn 
(now Pfizer, Inc.) notified FDA that ALBAMYCIN (novobiocin sodium) 
capsule, 250 mg, was no longer being manufactured. In a letter dated 
June 27, 2007, Pfizer, then the current holder of NDA 50-339, notified 
FDA that ALBAMYCIN (novobiocin sodium) capsule, 250 mg, had been 
discontinued. In the Federal Register of February 11, 2009 (74 FR 
6896), FDA announced that it was withdrawing approval of NDA 50-339 in 
response to Pfizer's withdrawal request. As a result, ALBAMYCIN 
(novobiocin sodium) capsule, 250 mg, was moved to the ``Discontinued 
Drug Product List'' section of the Orange Book.
    Crixmore LLC submitted a citizen petition dated July 9, 2008 
(Docket No. FDA-2008-P-0431), under 21 CFR 10.30, requesting that the 
Agency determine whether ALBAMYCIN (novobiocin sodium) capsule, 250 mg, 
was withdrawn from sale for reasons of safety or effectiveness.
    After considering the citizen petition and reviewing Agency 
records, FDA has determined under Sec.  314.161 that ALBAMYCIN 
(novobiocin sodium) capsule, 250 mg, was withdrawn for reasons of 
safety or effectiveness. The petitioner stated that it had identified 
no data or other information suggesting that ALBAMYCIN (novobiocin 
sodium) capsule, 250 mg, was withdrawn for reasons of safety or 
effectiveness and speculated that the discontinuation of this product 
was an economic/strategic decision totally unrelated to safety and/or 
efficacy. We have carefully reviewed our files for records concerning 
the withdrawal of ALBAMYCIN (novobiocin sodium) capsule, 250 mg, from 
sale. We have also independently evaluated relevant literature and data 
for possible postmarketing adverse events. The literature and adverse 
event reports reveal several significant safety concerns. Reported 
adverse reactions include relatively common skin reactions, jaundice, 
hepatic failure, and blood dyscrasias (neutropenia, anemia, and 
thrombocytopenia). The literature also reveals concern about the 
development of novobiocin-resistant Staphylococci during treatment, and 
a potential for drug interactions. In light of the significant safety 
concerns with this product, we conclude that the withdrawal of this 
product from the market was on the basis of safety or effectiveness.
    Accordingly, the Agency will remove ALBAMYCIN (novobiocin sodium) 
capsule, 250 mg, from the list of drug products published in the Orange 
Book. FDA will not accept or approve ANDAs that refer to this drug 
product.

    Dated: January 13, 2011.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2011-1000 Filed 1-18-11; 8:45 am]
BILLING CODE 4160-01-P