[Federal Register Volume 84, Number 65 (Thursday, April 4, 2019)]
[Notices]
[Pages 13298-13299]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06552]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-P-3412]
Determination That QVAR 40 and QVAR 80 (Beclomethasone
Dipropionate HFA) Inhalation Aerosol, 40 Micrograms and 80 Micrograms,
Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness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 or Agency) has
determined that QVAR 40 and QVAR 80 (beclomethasone dipropionate HFA)
inhalation aerosol, 40 micrograms (mcg) and 80 mcg, were not withdrawn
from sale for reasons of safety or effectiveness. This determination
will allow FDA to approve abbreviated new drug applications (ANDAs) for
QVAR 40 and QVAR 80 (beclomethasone dipropionate HFA) inhalation
aerosol, 40 mcg and 80 mcg, if all other legal and regulatory
requirements are met.
FOR FURTHER INFORMATION CONTACT: Nikki Mueller, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6280, Silver Spring, MD 20993-0002, 301-
796-3507.
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.
[[Page 13299]]
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 (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.
QVAR 40 and QVAR 80 (beclomethasone dipropionate HFA) inhalation
aerosol, 40 mcg and 80 mcg, are the subject of NDA 020911, held by TEVA
Branded Pharmaceutical Products R&D, Inc. (TEVA), and initially
approved on September 15, 2000. QVAR 40 and QVAR 80 are indicated for
the maintenance treatment of asthma as a prophylactic therapy in
patients 5 years of age and older.
Aurolife Pharma LLC submitted a citizen petition dated September 6,
2018 (Docket No. FDA-2018-P-3412), under 21 CFR 10.30, requesting that
the Agency determine whether QVAR 40 and QVAR 80 (beclomethasone
dipropionate HFA) inhalation aerosol, 40 mcg and 80 mcg, were withdrawn
from sale for reasons of safety or effectiveness.
After considering the citizen petition and reviewing Agency records
and based on the information we have at this time, FDA has determined
under Sec. 314.161 that QVAR 40 and QVAR 80 (beclomethasone
dipropionate HFA) inhalation aerosol, 40 mcg and 80 mcg, were not
withdrawn for reasons of safety or effectiveness. The petitioner has
identified no data or other information suggesting that QVAR 40 and
QVAR 80 (beclomethasone dipropionate HFA) inhalation aerosol, 40 mcg
and 80 mcg, were withdrawn for reasons of safety or effectiveness. In
addition, the petitioner provided information indicating that TEVA made
a business decision to discontinue manufacturing of these drug
products. We have carefully reviewed our files for records concerning
the withdrawal of QVAR 40 and QVAR 80 (beclomethasone dipropionate HFA)
inhalation aerosol, 40 mcg and 80 mcg, from sale. We have also
independently evaluated relevant literature and data for possible
postmarketing adverse events. We have reviewed the available evidence
and determined that these drug products were not withdrawn from sale
for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list QVAR 40 and QVAR 80
(beclomethasone dipropionate HFA) inhalation aerosol, 40 mcg and 80
mcg, 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 QVAR 40
and QVAR 80 (beclomethasone dipropionate HFA) inhalation aerosol, 40
mcg and 80 mcg, may 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 this drug product should be revised to
meet current standards, the Agency will advise ANDA applicants to
submit such labeling.
Dated: March 29, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-06552 Filed 4-3-19; 8:45 am]
BILLING CODE 4164-01-P