[Federal Register Volume 76, Number 27 (Wednesday, February 9, 2011)]
[Notices]
[Pages 7219-7220]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-2890]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2005-P-0394] (formerly Docket No. 2005P-0168)
Determination That DECASPRAY (Dexamethasone) Topical Aerosol,
0.04%, and AEROSEB-DEX (Dexamethasone) Topical Aerosol, 0.01%, 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Withdrawn From Sale for Reasons of Safety or Effectiveness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
DECASPRAY (dexamethasone) Topical Aerosol, 0.04%, and AEROSEB-DEX
(dexamethasone) Topical Aerosol, 0.01%, were not withdrawn from sale
for reasons of safety or effectiveness. This determination will allow
FDA to approve abbreviated new drug applications (ANDAs) for
dexamethasone topical aerosol, 0.04% and 0.01%, if all other legal and
regulatory requirements are met. However, in considering whether to
file an ANDA for dexamethasone topical aerosol, 0.04% and 0.01%, future
applicants are advised that they may not be able to obtain DECASPRAY
(dexamethasone) Topical Aerosol, 0.04%, or AEROSEB-DEX (dexamethasone)
Topical Aerosol, 0.01%, for bioequivalence testing because the products
have not been commercially available for a number of years. An ANDA
applicant who is unable to obtain DECASPRAY (dexamethasone) Topical
Aerosol, 0.04%, or AEROSEB-DEX (dexamethasone) Topical Aerosol, 0.01%,
for bioequivalence testing should contact the Office of Generic Drugs
for a determination of what is necessary to show bioavailability and
same therapeutic effect.
FOR FURTHER INFORMATION CONTACT: Janice Weiner, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6304, 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 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
[[Page 7220]]
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 that has been
voluntarily withdrawn from sale was withdrawn for reasons of safety or
effectiveness. This determination may be made at any time after the
drug has been voluntarily 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.
AEROSEB-DEX (dexamethasone) Topical Aerosol, 0.01%, is the subject
of ANDA 83-296, held by Allergan Herbert (Allergan) and initially
approved on June 15, 1973. AEROSEB-DEX is indicated for relief of the
inflammatory and pruritic manifestations of corticosteroid-responsive
dermatoses.
In its June 1997 annual report, Allergan notified FDA that AEROSEB-
DEX (dexamethasone) Topical Aerosol, 0.01%, was being discontinued, and
FDA moved the drug product to the ``Discontinued Drug Product List''
section of the Orange Book. In a letter dated August 28, 1998, Allergan
requested withdrawal of ANDA 83-296 for AEROSEB-DEX (dexamethasone)
Topical Aerosol, 0.01%. In the Federal Register of June 10, 1999 (64 FR
31226), FDA announced that it was withdrawing approval of ANDA 83-296,
effective July 12, 1999.
Acaderm Inc., (Acaderm) submitted a citizen petition dated April
28, 2005 (Docket No. FDA-2005-P-0394), under 21 CFR 10.30, requesting
that the Agency determine whether AEROSEB-DEX (dexamethasone) Topical
Aerosol, 0.01%, was withdrawn from sale for reasons of safety or
effectiveness. Although the citizen petition did not address DECASPRAY
(dexamethasone) Topical Aerosol, 0.04%, that dexamethasone topical
aerosol product has also been discontinued. On our own initiative, we
have also determined whether DECASPRAY (dexamethasone) Topical Aerosol,
0.04%, was withdrawn for safety or effectiveness reasons.
DECASPRAY (dexamethasone) Topical Aerosol, 0.04%, is the subject of
NDA 12-731, held by Merck & Co., Inc. (Merck). DECASPRAY, a synthetic
adrenocortical steroid, was initially approved on March 29, 1961,
solely on the basis of safety. The 1962 amendments to the FD&C Act
require that drugs be shown to be effective as well. To accomplish
this, FDA initiated the Drug Efficacy Study Implementation (DESI)
review to evaluate the effectiveness of drugs that had been previously
approved on safety grounds alone. In its DESI review of topical
corticosteroids, FDA concluded that NDA 12-731 for dexamethasone
topical aerosol was effective for certain indications (see 36 FR 7982,
April 28, 1971), and it was labeled for relief of the inflammatory and
pruritic manifestations of corticosteroid-responsive dermatoses.
In its annual report, Merck notified FDA that DECASPRAY
(dexamethasone) Topical Aerosol, 0.04%, was being discontinued, and FDA
moved the drug product to the ``Discontinued Drug Product List''
section of the Orange Book. In a letter dated June 25, 2002, Merck
requested withdrawal of NDA 12-731 for DECASPRAY (dexamethasone)
Topical Aerosol, 0.04%. In the Federal Register of August 18, 2003 (68
FR 49481), FDA announced that it was withdrawing approval of NDA 12-
731, effective September 17, 2003.
After considering the citizen petition and comments submitted to
the docket, and reviewing Agency records, FDA has determined under
Sec. 314.161 that AEROSEB-DEX (dexamethasone) Topical Aerosol, 0.01%,
was not withdrawn from sale for reasons of safety or effectiveness. The
petitioner has identified no data or other information suggesting that
AEROSEB-DEX (dexamethasone) Topical Aerosol, 0.01%, was withdrawn for
reasons of safety or effectiveness. We have carefully reviewed our
files for records concerning the withdrawal of AEROSEB-DEX
(dexamethasone) Topical Aerosol, 0.01%, from sale and have found no
information that would indicate that this product was withdrawn from
sale for reasons of safety or effectiveness.
FDA has also determined under Sec. 314.161 that DECASPRAY
(dexamethasone) Topical Aerosol, 0.04%, was not withdrawn for reasons
of safety or effectiveness. We have carefully reviewed our files for
records concerning the withdrawal of DECASPRAY (dexamethasone) Topical
Aerosol, 0.04%, 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 this product was
withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list DECASPRAY
(dexamethasone) Topical Aerosol, 0.04%, and AEROSEB-DEX (dexamethasone)
Topical Aerosol, 0.01%, 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 DECASPRAY (dexamethasone) Topical
Aerosol, 0.04%, and AEROSEB-DEX (dexamethasone) Topical Aerosol, 0.01%,
may be approved by the Agency as long as they meet all other legal and
regulatory requirements for 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.
In considering whether to file an ANDA for this drug product,
future applicants should be advised that they may not be able to obtain
DECASPRAY (dexamethasone) Topical Aerosol, 0.04%, or AEROSEB-DEX
(dexamethasone) Topical Aerosol, 0.01%, for bioequivalence testing
because the products have not been commercially available for a number
of years. An ANDA applicant who is unable to obtain DECASPRAY
(dexamethasone) Topical Aerosol, 0.04%, or AEROSEB-DEX (dexamethasone)
Topical Aerosol, 0.01%, for bioequivalence testing should contact the
Office of Generic Drugs for a determination of what showing is
necessary to satisfy the requirements of section 505(j)(2)(A)(iv) of
the FD&C Act. If an ANDA is approved without a showing of
bioequivalence, the approved product will not be considered
therapeutically equivalent to the reference listed drug, i.e., granted
an AB rating, in the Orange Book.
Dated: February 3, 2011.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2011-2890 Filed 2-8-11; 8:45 am]
BILLING CODE 4160-01-P