81 FR 78606 - Determination That CALAN SR (Verapamil Hydrochloride) Extended-Release Oral Tablet, 180 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness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 216 (November 8, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 216 (November 8, 2016)
| Page Range | 78606-78607 | |
| FR Document | 2016-26932 |
[Federal Register Volume 81, Number 216 (Tuesday, November 8, 2016)] [Notices] [Pages 78606-78607] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-26932] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-P-2674] Determination That CALAN SR (Verapamil Hydrochloride) Extended- Release Oral Tablet, 180 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) has determined that CALAN SR (verapamil hydrochloride) extended-release oral tablet, 180 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for verapamil hydrochloride extended-release oral tablet, 180 mg, if all other legal and regulatory requirements are met. FOR FURTHER INFORMATION CONTACT: Stacy Kane, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002, 301-796-8363. 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. CALAN SR (verapamil hydrochloride) extended-release oral tablet, 180 mg, is the subject of NDA 019152 held by Pfizer Inc. CALAN SR is indicated for the treatment of hypertension, to lower blood pressure. CALAN SR (verapamil hydrochloride) extended-release oral tablet, 180 mg, is currently listed in the ``Discontinued Drug Product List'' section of the Orange Book. Heritage Pharma Labs, Inc., submitted a citizen petition dated August 31, 2016 (Docket No. FDA-2016-P-2674), under 21 CFR 10.30, requesting that the Agency determine whether CALAN SR (verapamil hydrochloride) extended-release oral tablet, 180 mg, 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 CALAN SR (verapamil hydrochloride) extended-release oral tablet, 180 mg, was not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that CALAN SR (verapamil hydrochloride) extended-release oral tablet, 180 mg, was withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of CALAN SR (verapamil hydrochloride) extended-release oral tablet, 180 mg, from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. We have found no information that would indicate that this drug product was withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list CALAN SR (verapamil hydrochloride) extended-release oral [[Page 78607]] tablet, 180 mg, 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 CALAN SR (verapamil hydrochloride) extended-release oral tablet, 180 mg, 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: November 3, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-26932 Filed 11-7-16; 8:45 am] BILLING CODE 4164-01-P
![78606 Federal Register / Vol. 81, No. 216 / Tuesday, November 8, 2016 / Notices
Ave., Bldg. 21, Rm. 3557, Silver Spring, Dated: November 3, 2016. Therapeutic Equivalence Evaluations,’’
MD 20993–0002, 301–796–2055; or Leslie Kux, which is known generally as the
Robert Temple, Center for Drug Associate Commissioner for Policy. ‘‘Orange Book.’’ Under FDA regulations,
Evaluation and Research, Food and [FR Doc. 2016–26931 Filed 11–7–16; 8:45 am] drugs are removed from the list if the
Drug Administration, 10903 New BILLING CODE 4164–01–P
Agency withdraws or suspends
Hampshire Ave., Bldg. 22, Rm. 4212, approval of the drug’s NDA or ANDA
Silver Spring, MD 20993–0002, 301– for reasons of safety or effectiveness or
796–2270; or Stephen Ripley, Center for DEPARTMENT OF HEALTH AND if FDA determines that the listed drug
Biologics Evaluation and Research, HUMAN SERVICES was withdrawn from sale for reasons of
Food and Drug Administration, 10903 safety or effectiveness (21 CFR 314.162).
Food and Drug Administration A person may petition the Agency to
New Hampshire Ave., Bldg. 71, Rm.
determine, or the Agency may
7301, Silver Spring, MD 20993–0002, [Docket No. FDA–2016–P–2674] determine on its own initiative, whether
240–402–7911. a listed drug was withdrawn from sale
Determination That CALAN SR
SUPPLEMENTARY INFORMATION: for reasons of safety or effectiveness.
(Verapamil Hydrochloride) Extended-
This determination may be made at any
I. Background Release Oral Tablet, 180 Milligrams,
time after the drug has been withdrawn
Was Not Withdrawn From Sale for
FDA is announcing the availability of from sale, but must be made prior to
Reasons of Safety or Effectiveness
approving an ANDA that refers to the
a guidance for industry entitled ‘‘Non-
AGENCY: Food and Drug Administration, listed drug (§ 314.161 (21 CFR 314.161)).
Inferiority Clinical Trials to Establish
HHS. FDA may not approve an ANDA that
Effectiveness.’’ This guidance consists does not refer to a listed drug.
of four parts. The first part is a general ACTION: Notice.
CALAN SR (verapamil hydrochloride)
discussion of regulatory, study design, extended-release oral tablet, 180 mg, is
SUMMARY: The Food and Drug
scientific, and statistical issues Administration (FDA or Agency) has the subject of NDA 019152 held by
associated with the use of NI studies to determined that CALAN SR (verapamil Pfizer Inc. CALAN SR is indicated for
establish the effectiveness of a drug or hydrochloride) extended-release oral the treatment of hypertension, to lower
biologic. The second part focuses on tablet, 180 milligrams (mg), was not blood pressure. CALAN SR (verapamil
some of these issues in more detail, withdrawn from sale for reasons of hydrochloride) extended-release oral
notably the statistical approaches used safety or effectiveness. This tablet, 180 mg, is currently listed in the
to determine the NI margin and to test determination will allow FDA to ‘‘Discontinued Drug Product List’’
for non-inferiority. The third part approve abbreviated new drug section of the Orange Book.
addresses commonly asked questions applications (ANDAs) for verapamil Heritage Pharma Labs, Inc., submitted
about NI studies. The fourth part hydrochloride extended-release oral a citizen petition dated August 31, 2016
includes four examples of successful tablet, 180 mg, if all other legal and (Docket No. FDA–2016–P–2674), under
and unsuccessful efforts to define NI regulatory requirements are met. 21 CFR 10.30, requesting that the
margins and test for non-inferiority. Agency determine whether CALAN SR
FOR FURTHER INFORMATION CONTACT:
(verapamil hydrochloride) extended-
This guidance finalizes the draft Stacy Kane, Center for Drug Evaluation release oral tablet, 180 mg, was
guidance for industry, ‘‘Non-Inferiority and Research, Food and Drug withdrawn from sale for reasons of
Clinical Trials,’’ published in 2010. In Administration, 10903 New Hampshire safety or effectiveness.
addition, it supersedes the guidance for Ave., Bldg. 51, Rm. 6236, Silver Spring, After considering the citizen petition
industry, ‘‘Antibacterial Drug Products: MD 20993–0002, 301–796–8363. and reviewing Agency records, and
Use of Noninferiority Trials to Support SUPPLEMENTARY INFORMATION: In 1984, based on the information we have at this
Approval,’’ also published in 2010, Congress enacted the Drug Price time, FDA has determined under
which will be withdrawn. Competition and Patent Term § 314.161 that CALAN SR (verapamil
This guidance is being issued Restoration Act of 1984 (Pub. L. 98–417) hydrochloride) extended-release oral
consistent with FDA’s good guidance (the 1984 amendments), which tablet, 180 mg, was not withdrawn for
practices regulation (21 CFR 10.115). authorized the approval of duplicate reasons of safety or effectiveness. The
The guidance represents the current versions of drug products under an petitioner has identified no data or other
thinking of FDA on NI clinical trials to ANDA procedure. ANDA applicants information suggesting that CALAN SR
establish effectiveness. It does not must, with certain exceptions, show that (verapamil hydrochloride) extended-
the drug for which they are seeking release oral tablet, 180 mg, was
establish any rights for any person and
approval contains the same active withdrawn for reasons of safety or
is not binding on FDA or the public.
ingredient in the same strength and effectiveness. We have carefully
You can use an alternative approach if
dosage form as the ‘‘listed drug,’’ which reviewed our files for records
it satisfies the requirements of the
is a version of the drug that was concerning the withdrawal of CALAN
applicable statutes and regulations.
previously approved. ANDA applicants SR (verapamil hydrochloride) extended-
II. Electronic Access do not have to repeat the extensive release oral tablet, 180 mg, from sale.
clinical testing otherwise necessary to We have also independently evaluated
Persons with access to the Internet gain approval of a new drug application relevant literature and data for possible
may obtain the guidance at http:// (NDA). postmarketing adverse events. We have
mstockstill on DSK3G9T082PROD with NOTICES
www.fda.gov/Drugs/Guidance The 1984 amendments include what found no information that would
ComplianceRegulatoryInformation/ is now section 505(j)(7) of the Federal indicate that this drug product was
Guidances/default.htm; http:// Food, Drug, and Cosmetic Act (21 U.S.C. withdrawn from sale for reasons of
www.fda.gov/BiologicsBloodVaccines/ 355(j)(7)), which requires FDA to safety or effectiveness.
GuidanceComplianceRegulatory publish a list of all approved drugs. Accordingly, the Agency will
Information/Guidances/default.htm; or FDA publishes this list as part of the continue to list CALAN SR (verapamil
http://www.regulations.gov. ‘‘Approved Drug Products With hydrochloride) extended-release oral
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![Federal Register / Vol. 81, No. 216 / Tuesday, November 8, 2016 / Notices 78607
tablet, 180 mg, in the ‘‘Discontinued ADDRESSES: Location: The public Instructions: All submissions received
Drug Product List’’ section of the Orange workshop will be held at the Barbara must include the Docket No. FDA–
Book. The ‘‘Discontinued Drug Product Jordan Conference Center at the Kaiser 2016–N–3631 for ‘‘Ninth Annual
List’’ delineates, among other items, Family Foundation, 1330 G St. NW., Sentinel Initiative; Public Workshop.’’
drug products that have been Washington, DC 20005. For additional Received comments will be placed in
discontinued from marketing for reasons travel and hotel information, please the docket and, except for those
other than safety or effectiveness. refer to https://healthpolicy.duke.edu/ submitted as ‘‘Confidential
ANDAs that refer to CALAN SR events/ninth-annual-sentinel-initiative- Submissions,’’ publicly viewable at
(verapamil hydrochloride) extended- public-workshop. FDA has verified the http://www.regulations.gov or at the
release oral tablet, 180 mg, may be meeting Web site addresses throughout Division of Dockets Management
approved by the Agency as long as they this notice, but FDA is not responsible between 9 a.m. and 4 p.m., Monday
meet all other legal and regulatory for subsequent changes to the Web sites through Friday.
requirements for the approval of after this document publishes in the • Confidential Submissions—To
ANDAs. If FDA determines that labeling Federal Register. There will also be a submit a comment with confidential
for this drug product should be revised live Webcast for those unable to attend information that you do not wish to be
to meet current standards, the Agency the meeting in person (see Streaming made publicly available, submit your
will advise ANDA applicants to submit Webcast of the Public Workshop). comments only as a written/paper
such labeling. You may submit comments as submission. You should submit two
Dated: November 3, 2016. follows: copies total. One copy will include the
Leslie Kux,
information you claim to be confidential
Electronic Submissions with a heading or cover note that states
Associate Commissioner for Policy.
Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS
[FR Doc. 2016–26932 Filed 11–7–16; 8:45 am]
following way: CONFIDENTIAL INFORMATION.’’ The
BILLING CODE 4164–01–P
• Federal eRulemaking Portal: http:// Agency will review this copy, including
www.regulations.gov. Follow the the claimed confidential information, in
instructions for submitting comments. its consideration of comments. The
DEPARTMENT OF HEALTH AND
Comments submitted electronically, second copy, which will have the
HUMAN SERVICES
including attachments, to http:// claimed confidential information
Food and Drug Administration www.regulations.gov will be posted to redacted/blacked out, will be available
the docket unchanged. Because your for public viewing and posted on http://
[Docket No. FDA–2016–N–3631] comment will be made public, you are www.regulations.gov. Submit both
solely responsible for ensuring that your copies to the Division of Dockets
Ninth Annual Sentinel Initiative; Public Management. If you do not wish your
comment does not include any
Workshop name and contact information to be
confidential information that you or a
AGENCY: Food and Drug Administration, third party may not wish to be posted, made publicly available, you can
HHS. such as medical information, your or provide this information on the cover
ACTION: Notice of public workshop; anyone else’s Social Security number, or sheet and not in the body of your
request for comments. confidential business information, such comments and you must identify this
as a manufacturing process. Please note information as ‘‘confidential.’’ Any
SUMMARY: The Food and Drug that if you include your name, contact information marked as ‘‘confidential’’
Administration (FDA) is announcing a information, or other information that will not be disclosed except in
public workshop entitled ‘‘Ninth identifies you in the body of your accordance with 21 CFR 10.20 and other
Annual Sentinel Initiative Public comments, that information will be applicable disclosure law. For more
Workshop.’’ Convened by the Duke- posted on http://www.regulations.gov. information about FDA’s posting of
Margolis Center for Health Policy at • If you want to submit a comment comments to public dockets, see 80 FR
Duke University and supported by a with confidential information that you 56469, September 18, 2015, or access
cooperative agreement with FDA, this 1- do not wish to be made available to the the information at: http://www.fda.gov/
day workshop will bring the stakeholder public, submit the comment as a regulatoryinformation/dockets/
community together to discuss a variety written/paper submission and in the default.htm.
of topics on active medical product manner detailed (see ‘‘Written/Paper Docket: For access to the docket to
surveillance. Topics will include an Submissions’’ and ‘‘Instructions’’). read background documents or the
update on the state of FDA’s Sentinel electronic and written/paper comments
Initiative, including an overview of the Written/Paper Submissions received, go to http://
current state of Sentinel System safety Submit written/paper submissions as www.regulations.gov and insert the
surveillance activities, and uses of the follows: docket number, found in brackets in the
Sentinel System accomplished in 2016. • Mail/Hand delivery/Courier (for heading of this document, into the
In addition, panelists will discuss the written/paper submissions): Division of ‘‘Search’’ box and follow the prompts
future of the Sentinel System and Dockets Management (HFA–305), Food and/or go to the Division of Dockets
opportunities to expand its medical and Drug Administration, 5630 Fishers Management, 5630 Fishers Lane, Rm.
product surveillance capabilities. This Lane, Rm. 1061, Rockville, MD 20852. 1061, Rockville, MD 20852.
workshop will also engage stakeholders • For written/paper comments FOR FURTHER INFORMATION CONTACT:
mstockstill on DSK3G9T082PROD with NOTICES
to discuss current and emerging submitted to the Division of Dockets Carlos Bell, Center for Drug Evaluation
Sentinel Initiative projects. Management, FDA will post your and Research, Food and Drug
DATES: The public workshop will be comment, as well as any attachments, Administration, 10903 New Hampshire
held on February 2, 2017, from 9 a.m. except for information submitted, Ave., Bldg. 22, Rm. 4343, Silver Spring,
to 4:30 p.m., Eastern Standard Time marked and identified, as confidential, MD 20993–0002, 301–796–3714, FAX:
(EST). Submit either electronic or if submitted as detailed in 301–796–9832, email:
written comments by March 2, 2017. ‘‘Instructions.’’ SentinelInitiative@fda.hhs.gov.
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Document Created: 2018-02-14 08:23:51
Document Modified: 2018-02-14 08:23:51
| 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 | Stacy Kane, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002, 301-796-8363. | |
| FR Citation | 81 FR 78606 |
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