[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Injection, 30 Milligrams/Vial, Was Not Withdrawn From Sale for Reasons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milligrams (mg)/vial, was not withdrawn from sale for reasons of safety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drug was withdrawn from sale for reasons of safety or effectiveness (21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