[Federal Register Volume 81, Number 174 (Thursday, September 8, 2016)]
[Notices]
[Pages 62143-62144]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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Injection, 30 Milligrams/Vial, Was Not Withdrawn From Sale for Reasons 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.

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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milligrams (mg)/vial, was not withdrawn from sale for reasons of safety 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