[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Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness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inhalation aerosol, 40 micrograms (mcg) and 80 mcg, were not withdrawn 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


