[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Milligrams and 250 Milligrams, Were Not Withdrawn From Sale for Reasons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DIAMOX (acetazolamide) tablets, 125 mg and 250 mg, were not withdrawn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