[Federal Register Volume 79, Number 208 (Tuesday, October 28, 2014)]
[Notices]
[Pages 64201-64202]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-25534]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-P-0979]


Determination That DIAMOX (Acetazolamide) Intravenous, 500 
Milligrams Base/Vial, and DIAMOX (Acetazolamide) Tablets, 125 
Milligrams and 250 Milligrams, Were Not Withdrawn From Sale for Reasons 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) has determined that 
DIAMOX (acetazolamide) intravenous, 500 milligrams (mg) base/vial, and 
DIAMOX (acetazolamide) tablets, 125 mg and 250 mg, were not withdrawn 
from sale for reasons of safety or effectiveness. This determination 
means that FDA will not begin procedures to withdraw approval of 
abbreviated new drug applications (ANDAs) that refer to these drug 
products, and it will allow FDA to continue to approve ANDAs that refer 
to these products, if all other legal and regulatory requirements are 
met.

FOR FURTHER INFORMATION CONTACT: Ayako Sato, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, Rm. 6228, Silver Spring, MD 20993-0002, 240-402-4191.

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 
(Sec.  314.162 (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.
    DIAMOX (acetazolamide) intravenous, 500 mg base/vial, is the 
subject of NDA 009-388, held by Teva Branded Pharmaceutical Products 
R&D, Inc., and initially approved on June 25, 1954. DIAMOX 
(acetazolamide) tablets, 125 mg and 250 mg, are the subject of NDA 008-
943, held by Teva Branded Pharmaceutical Products R&D, Inc., and 
initially approved on July 27, 1953. DIAMOX (acetazolamide) 
intravenous, 500 mg base/vial, and DIAMOX (acetazolamide) tablets, 125 
mg and 250 mg, are indicated for adjunctive treatment of: Edema due to 
congestive heart failure; drug-induced edema; centrencephalic 
epilepsies (petit mal, unlocalized seizures); and chronic simple (open-
angle) glaucoma, secondary glaucoma, and preoperatively in acute angle-
closure glaucoma where delay of surgery is desired in order to lower 
intraocular pressure. DIAMOX (acetazolamide) intravenous, 500 mg base/
vial, and DIAMOX (acetazolamide) tablets, 125 mg and 250 mg, are also 
indicated for the prevention or amelioration of symptoms associated 
with acute mountain sickness in climbers attempting rapid ascent and in 
those who are very susceptible to acute mountain sickness despite 
gradual ascent.
    DIAMOX (acetazolamide) intravenous, 500 mg base/vial, and DIAMOX 
(acetazolamide) tablets, 125 mg and 250 mg, are currently listed in the 
``Discontinued Drug Product List'' section of the Orange Book.
    Emcure Pharmaceuticals USA, Inc., submitted a citizen petition 
dated July 3, 2014 (Docket No. FDA-2014-P-0979), under 21 CFR 10.30, 
requesting that the Agency determine that DIAMOX (acetazolamide) 
intravenous, 500 mg base/vial, was discontinued for reasons unrelated 
to safety and effectiveness. Although the citizen petition did not 
address DIAMOX (acetazolamide) tablets, 125 mg and 250 mg, since those 
products have also been discontinued, on our own initiative, we 
therefore determined whether DIAMOX (acetazolamide) tablets, 125 mg and 
250 mg, were withdrawn for safety or effectiveness reasons.
    After considering the citizen petition and reviewing Agency 
records, FDA has determined under Sec.  314.161 that DIAMOX 
(acetazolamide) intravenous, 500 mg base/vial, and DIAMOX 
(acetazolamide) tablets, 125 mg and 250 mg, were not withdrawn for 
reasons of safety or effectiveness. The petitioner has identified no 
data or other information suggesting that DIAMOX (acetazolamide) 
intravenous, 500 mg base/vial, was withdrawn for reasons of safety or 
effectiveness. We have carefully reviewed our files for records 
concerning the withdrawal of DIAMOX (acetazolamide) intravenous, 500 mg 
base/vial, and DIAMOX (acetazolamide) tablets, 125 mg and 250 mg from 
sale. We have also independently evaluated relevant literature and data 
for possible postmarketing adverse events and have found no information 
that would indicate that these products were

[[Page 64202]]

withdrawn from sale for reasons of safety or effectiveness.
    Accordingly, the Agency will continue to list DIAMOX 
(acetazolamide) intravenous, 500 mg base/vial, and DIAMOX 
(acetazolamide) tablets, 125 mg and 250 mg, 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. FDA will not begin procedures to withdraw approval of 
ANDAs that refer to DIAMOX (acetazolamide) intravenous, 500 mg base/
vial, and DIAMOX (acetazolamide) tablets, 125 mg and 250 mg. Additional 
ANDAs that refer to these products may also 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 
advise ANDA applicants to submit such labeling.

    Dated: October 21, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-25534 Filed 10-27-14; 8:45 am]
BILLING CODE 4164-01-P