[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Withdrawn From Sale for Reasons of Safety or Effectiveness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(dexamethasone) Topical Aerosol, 0.01%, were not withdrawn from sale 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