81 FR 62143 - Determination That PREVACID IV (Lansoprazole) Intravenous Injection, 30 Milligrams/Vial, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 174 (September 8, 2016)

Page Range		62143-62144
FR Document		2016-21551

The Food and Drug Administration (FDA or Agency) has determined that PREVACID IV (lansoprazole) intravenous injection, 30 milligrams (mg)/vial, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for lansoprazole intravenous injection, 30 mg/vial, if all other legal and regulatory requirements are met.

Federal Register, Volume 81 Issue 174 (Thursday, September 8, 2016)

[Federal Register Volume 81, Number 174 (Thursday, September 8, 2016)]
[Notices]
[Pages 62143-62144]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-21551]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-P-1037]


Determination That PREVACID IV (Lansoprazole) Intravenous 
Injection, 30 Milligrams/Vial, Was Not Withdrawn From Sale for Reasons 
of Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

[[Page 62144]]


ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) has 
determined that PREVACID IV (lansoprazole) intravenous injection, 30 
milligrams (mg)/vial, was not withdrawn from sale for reasons of safety 
or effectiveness. This determination will allow FDA to approve 
abbreviated new drug applications (ANDAs) for lansoprazole intravenous 
injection, 30 mg/vial, if all other legal and regulatory requirements 
are met.

FOR FURTHER INFORMATION CONTACT: Bronwen Blass, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6224, Silver Spring, MD 20993-0002, 301-
796-5092, [email protected].

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 (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.
    PREVACID IV (lansoprazole) intravenous injection, 30 mg/vial, is 
the subject of NDA 021566, held by Takeda Pharmaceuticals North 
America, Inc., and initially approved on May 27, 2004. The Indications 
and Usage section of the PREVACID IV labeling states the following: 
``When patients are unable to take the oral formulations, PREVACID I.V. 
for Injection is indicated as an alternative for the short-term 
treatment (up to 7 days) of all grades of erosive esophagitis. Once the 
patient is able to take medications orally, therapy can be switched to 
an oral formulation of PREVACID for a total of 6 to 8 weeks. The safety 
and efficacy of PREVACID I.V. for Injection as an initial treatment of 
erosive esophagitis have not been demonstrated. Refer to full 
prescribing information for the oral formulations of PREVACID.''
    In a letter dated February 5, 2007, Takeda Pharmaceuticals North 
America, Inc. notified FDA that PREVACID IV (lansoprazole) intravenous 
injection, 30 mg/vial, was being discontinued, and FDA moved the drug 
product to the ``Discontinued Drug Product List'' section of the Orange 
Book.
    Rose Zhao submitted a citizen petition dated March 18, 2016 (Docket 
No. FDA-2016-P-1037), under 21 CFR 10.30, requesting that the Agency 
determine whether PREVACID IV (lansoprazole) intravenous injection, 30 
mg/vial, was 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 PREVACID IV (lansoprazole) intravenous 
injection, 30 mg/vial, was not withdrawn for reasons of safety or 
effectiveness. The petitioner has identified no data or other 
information suggesting that PREVACID IV (lansoprazole) intravenous 
injection, 30 mg/vial, was withdrawn for reasons of safety or 
effectiveness. We have carefully reviewed our files for records 
concerning the withdrawal of PREVACID IV (lansoprazole) intravenous 
injection, 30 mg/vial, 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 this drug 
product was not withdrawn from sale for reasons of safety or 
effectiveness.
    Accordingly, the Agency will continue to list PREVACID IV 
(lansoprazole) intravenous injection, 30 mg/vial, 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 PREVACID IV (lansoprazole) 
intravenous injection, 30 mg/vial, 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: September 1, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-21551 Filed 9-7-16; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 174 / Thursday, September 8, 2016 / Notices 62143

comments be faxed to the Office of collection of information to OMB for accordance with part 822 (21 CFR part
Information and Regulatory Affairs, review and clearance. 822) in §§ 822.15 through 822.19 of the
OMB, Attn: FDA Desk Officer, FAX: regulation, which describe the grounds
202–395–7285, or emailed to oira_ Postmarket Surveillance—21 CFR Part for approving or disapproving a PS plan.
submission@omb.eop.gov. All 822—OMB Control Number 0910– In addition, the PS regulation provides
comments should be identified with the 0449—Extension instructions to manufacturers to submit
OMB control number 0910–0449. Also Section 522 of the Federal Food, Drug, interim and final reports in accordance
include the FDA docket number found and Cosmetic Act (21 U.S.C. 360l) with § 822.38. Respondents to this
in brackets in the heading of this authorizes FDA to require a collection of information are those
document. manufacturer to conduct postmarket manufacturers who require postmarket
FOR FURTHER INFORMATION CONTACT: FDA surveillance (PS) of any device that surveillance of their products.
PRA Staff, Office of Operations, Food meets the criteria set forth in the statute. In the Federal Register of April 28,
and Drug Administration, Three White The PS regulation establishes 2016 (81 FR 25409), FDA published a
Flint North, 10A63, 11601 Landsdown procedures that FDA uses to approve 60-day notice requesting public
St., North Bethesda, MD 20852, and disapprove PS plans. The regulation comment on the proposed collection of
PRAStaff@fda.hhs.gov. provides instructions to manufacturers information. No comments were
SUPPLEMENTARY INFORMATION: In so they know what information is received.
compliance with 44 U.S.C. 3507, FDA required in a PS plan submission. FDA FDA estimates the burden of this
has submitted the following proposed reviews PS plan submissions in collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Activity/21 CFR section responses per burden per Total hours
respondents responses
respondent response

Postmarket surveillance submission (§§ 822.9 and 822.10) 131 1 131 120 15,720
Changes to PS plan after approval (§ 822.21) .................... 15 1 15 40 600
Changes to PS plan for a device that is no longer mar-
keted (§ 822.28) ................................................................ 80 1 80 8 640
Waiver (§ 822.29) ................................................................. 1 1 1 40 40
Exemption request (§ 822.30) .............................................. 16 1 16 40 640
Periodic reports (§ 822.38) ................................................... 131 3 393 40 15,720

Total .............................................................................. ........................ ........................ ........................ ........................ 33,360
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Explanation of Reporting Burden Sections 822.26, 822.27, and 822.34 do that necessary to identify the
Estimate: The burden captured in table not constitute information collection respondent, the date, the respondents
1 of this document is based on the data subject to review under the PRA address, and the nature of the
from FDA’s internal tracking system. because it entails no burden other than instrument (See 5 CFR 1320.3(h)(1)).

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of Average
Number of Total annual
Activity/21 CFR section records per burden per Total hours
recordkeepers records
recordkeeper recordkeeping

Manufacturer records (§ 822.31) .......................................... 131 1 131 20 2,620
Investigator records (§ 822.32) ............................................ 393 1 393 5 1,965

Total .............................................................................. ........................ ........................ ........................ ........................ 4,585
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Explanation of Recordkeeping Burden Dated: September 1, 2016. DEPARTMENT OF HEALTH AND
Estimate: FDA expects that at least some Leslie Kux, HUMAN SERVICES
of the manufacturers will be able to Associate Commissioner for Policy.
satisfy the PS requirement using Food and Drug Administration
[FR Doc. 2016–21554 Filed 9–7–16; 8:45 am]
information or data they already have. BILLING CODE 4160–01–P
For purposes of calculating burden, [Docket No. FDA–2016–P–1037]
however, FDA has assumed that each PS
mstockstill on DSK3G9T082PROD with NOTICES

order can only be satisfied by a 3-year Determination That PREVACID IV
clinically based surveillance plan, using (Lansoprazole) Intravenous Injection,
three investigators. These estimates are 30 Milligrams/Vial, Was Not Withdrawn
From Sale for Reasons of Safety or
based on FDA’s knowledge and
Effectiveness
experience with postmarket
surveillance. AGENCY: Food and Drug Administration,
HHS.

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62144 Federal Register / Vol. 81, No. 174 / Thursday, September 8, 2016 / Notices

ACTION: Notice. FDA may not approve an ANDA that Book. The ‘‘Discontinued Drug Product
does not refer to a listed drug. List’’ delineates, among other items,
SUMMARY: The Food and Drug PREVACID IV (lansoprazole) drug products that have been
Administration (FDA or Agency) has intravenous injection, 30 mg/vial, is the discontinued from marketing for reasons
determined that PREVACID IV subject of NDA 021566, held by Takeda other than safety or effectiveness.
(lansoprazole) intravenous injection, 30 Pharmaceuticals North America, Inc., ANDAs that refer to PREVACID IV
milligrams (mg)/vial, was not and initially approved on May 27, 2004. (lansoprazole) intravenous injection, 30
withdrawn from sale for reasons of The Indications and Usage section of the mg/vial, may be approved by the
safety or effectiveness. This PREVACID IV labeling states the Agency as long as they meet all other
determination will allow FDA to following: ‘‘When patients are unable to legal and regulatory requirements for
approve abbreviated new drug take the oral formulations, PREVACID the approval of ANDAs. If FDA
applications (ANDAs) for lansoprazole I.V. for Injection is indicated as an determines that labeling for this drug
intravenous injection, 30 mg/vial, if all alternative for the short-term treatment product should be revised to meet
other legal and regulatory requirements (up to 7 days) of all grades of erosive current standards, the Agency will
are met. esophagitis. Once the patient is able to advise ANDA applicants to submit such
FOR FURTHER INFORMATION CONTACT: take medications orally, therapy can be labeling.
Bronwen Blass, Center for Drug switched to an oral formulation of
Dated: September 1, 2016.
Evaluation and Research, Food and PREVACID for a total of 6 to 8 weeks.
The safety and efficacy of PREVACID Leslie Kux,
Drug Administration, 10903 New
I.V. for Injection as an initial treatment Associate Commissioner for Policy.
Hampshire Ave., Bldg. 51, Rm. 6224,
Silver Spring, MD 20993–0002, 301– of erosive esophagitis have not been [FR Doc. 2016–21551 Filed 9–7–16; 8:45 am]
796–5092, Bronwen.blass@fda.hhs.gov. demonstrated. Refer to full prescribing BILLING CODE 4164–01–P
information for the oral formulations of
SUPPLEMENTARY INFORMATION: In 1984,
PREVACID.’’
Congress enacted the Drug Price In a letter dated February 5, 2007, DEPARTMENT OF HEALTH AND
Competition and Patent Term Takeda Pharmaceuticals North America, HUMAN SERVICES
Restoration Act of 1984 (Pub. L. 98–417) Inc. notified FDA that PREVACID IV
(the 1984 amendments), which (lansoprazole) intravenous injection, 30 Food and Drug Administration
authorized the approval of duplicate mg/vial, was being discontinued, and
versions of drug products under an FDA moved the drug product to the [Docket No. FDA–2016–N–2544]
ANDA procedure. ANDA applicants ‘‘Discontinued Drug Product List’’
must, with certain exceptions, show that section of the Orange Book. Agency Information Collection
the drug for which they are seeking Rose Zhao submitted a citizen Activities; Proposed Collection;
approval contains the same active petition dated March 18, 2016 (Docket Comment Request; Medical Device:
ingredient in the same strength and No. FDA–2016–P–1037), under 21 CFR Current Good Manufacturing Practice
dosage form as the ‘‘listed drug,’’ which 10.30, requesting that the Agency Quality System Regulations
is a version of the drug that was determine whether PREVACID IV
previously approved. ANDA applicants AGENCY: Food and Drug Administration,
(lansoprazole) intravenous injection, 30 HHS.
do not have to repeat the extensive mg/vial, was withdrawn from sale for
clinical testing otherwise necessary to reasons of safety or effectiveness. ACTION: Notice.
gain approval of a new drug application After considering the citizen petition SUMMARY: The Food and Drug
(NDA). and reviewing Agency records and Administration (FDA) is announcing an
The 1984 amendments include what based on the information we have at this opportunity for public comment on the
is now section 505(j)(7) of the Federal time, FDA has determined under proposed collection of certain
Food, Drug, and Cosmetic Act (21 U.S.C. § 314.161 that PREVACID IV information by the Agency. Under the
355(j)(7)), which requires FDA to (lansoprazole) intravenous injection, 30 Paperwork Reduction Act of 1995 (the
publish a list of all approved drugs. mg/vial, was not withdrawn for reasons PRA), Federal Agencies are required to
FDA publishes this list as part of the of safety or effectiveness. The petitioner publish notice in the Federal Register
‘‘Approved Drug Products With has identified no data or other concerning each proposed collection of
Therapeutic Equivalence Evaluations,’’ information suggesting that PREVACID information including each proposed
which is known generally as the IV (lansoprazole) intravenous injection, extension of an existing collection of
‘‘Orange Book.’’ Under FDA regulations, 30 mg/vial, was withdrawn for reasons information, and to allow 60 days for
drugs are removed from the list if the of safety or effectiveness. We have public comment in response to the
Agency withdraws or suspends carefully reviewed our files for records notice. This notice solicits comments on
approval of the drug’s NDA or ANDA concerning the withdrawal of recordkeeping requirements related to
for reasons of safety or effectiveness or PREVACID IV (lansoprazole) the medical devices current good
if FDA determines that the listed drug intravenous injection, 30 mg/vial, from manufacturing practice (CGMP) quality
was withdrawn from sale for reasons of sale. We have also independently system (QS) regulation (CGMP/QS
safety or effectiveness (21 CFR 314.162). evaluated relevant literature and data regulation).
A person may petition the Agency to for possible postmarketing adverse
determine, or the Agency may events. We have reviewed the available DATES: Submit either electronic or
determine on its own initiative, whether evidence and determined that this drug written comments on the collection of
mstockstill on DSK3G9T082PROD with NOTICES

a listed drug was withdrawn from sale product was not withdrawn from sale information by November 7, 2016.
for reasons of safety or effectiveness. for reasons of safety or effectiveness. ADDRESSES: You may submit comments
This determination may be made at any Accordingly, the Agency will as follows:
time after the drug has been withdrawn continue to list PREVACID IV
from sale, but must be made prior to (lansoprazole) intravenous injection, 30 Electronic Submissions
approving an ANDA that refers to the mg/vial, in the ‘‘Discontinued Drug Submit electronic comments in the
listed drug (§ 314.161 (21 CFR 314.161)). Product List’’ section of the Orange following way:

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Document Created: 2018-02-09 13:13:12
Document Modified: 2018-02-09 13:13:12

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Contact		Bronwen Blass, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6224, Silver Spring, MD 20993-0002, 301- 796-5092, [email protected]
FR Citation		81 FR 62143

81 FR 62143 - Determination That PREVACID IV (Lansoprazole) Intravenous Injection, 30 Milligrams/Vial, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 174 (September 8, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration