81 FR 92821 - Sun Pharmaceutical Industries, Inc.; Withdrawal of Approval of 28 Abbreviated New Drug Applications
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 244 (December 20, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 244 (December 20, 2016)
| Page Range | 92821-92822 | |
| FR Document | 2016-30623 |
[Federal Register Volume 81, Number 244 (Tuesday, December 20, 2016)] [Notices] [Pages 92821-92822] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-30623] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-4320] Sun Pharmaceutical Industries, Inc.; Withdrawal of Approval of 28 Abbreviated New Drug Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval of 28 abbreviated new drug applications held by Sun Pharmaceutical Industries, Inc. (Sun Pharmaceutical), U.S. Agent for Sun Pharmaceutical Industries Limited, 270 Prospect Plains Rd., Cranbury, NJ 08512. The drug products are no longer marketed, and Sun Pharmaceutical has requested that the approval of the applications be withdrawn. DATES: January 19, 2017. FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6248, Silver Spring, MD 20993-0002, 301- 796-3601. SUPPLEMENTARY INFORMATION: The applications listed in the table in this document are no longer marketed, and Sun Pharmaceutical has requested that FDA withdraw approval of the applications. The company has also, by its request, waived its opportunity for a hearing. ------------------------------------------------------------------------ Application No. Drug ------------------------------------------------------------------------ 065007........................... Cephalexin Capsules USP, Equivalent to (EQ) 250 milligrams (mg) base and EQ 500 mg base. 065016........................... Amoxicillin Capsules USP, 250 mg and 500 mg. 065021........................... Amoxicillin Tablets USP (Chewable), 125 mg and 250 mg. 065059........................... Amoxicillin Tablets USP, 500 mg and 875 mg. 065060........................... Amoxicillin Tablets USP (Chewable), 200 mg and 400 mg. 065081........................... Cephalexin for Oral Suspension USP, EQ 125 mg base/5 milliliters (mL) and EQ 250 mg base/5 mL. 065082........................... Cefpodoxime Proxetil for Oral Suspension USP, EQ 50 mg base/5 mL and EQ 100 mg base/5 mL. 065083........................... Cefpodoxime Proxetil Tablets USP, EQ 100 mg base and EQ 200 mg base. [[Page 92822]] 065102........................... Amoxicillin and Clavulanate Potassium Tablets USP, 875 mg/EQ 125 mg base. 065109........................... Amoxicillin and Clavulanate Potassium Tablets USP, 500 mg/EQ 125 mg base. 065113........................... Amoxicillin for Oral Suspension USP, 200 mg/5 mL and 400 mg/5 mL. 065115........................... Cefadroxil for Oral Suspension USP, EQ 125 mg base/5 mL, EQ 250 mg base/ 5 mL, and EQ 500 mg base/5 mL. 065118........................... Cefuroxime Axetil Tablets USP, EQ 125 mg base, EQ 250 mg base, and EQ 500 mg base. 065132........................... Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 200 mg/EQ 28.5 mg base per 5 mL and 400 mg/EQ 57 mg base per 5 mL. 065161........................... Amoxicillin and Clavulanate Potassium Tablets USP (Chewable), 200 mg/EQ 28.5 mg base and 400 mg/EQ 57 mg base. 065207........................... Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 600 mg/EQ 42.9 mg base per 5 mL. 065323........................... Cefuroxime Axetil for Oral Suspension USP, EQ 125 mg base/5 mL and EQ 250 mg base/5 mL. 074975........................... Acyclovir Capsules USP, 200 mg. 074980........................... Acyclovir Tablets USP, 400 mg and 800 mg. 075132........................... Ranitidine Tablets USP, EQ 75 mg base. 075439........................... Ranitidine Tablets USP, EQ 150 mg base and EQ 300 mg base. 076041........................... Sotret (isotretinoin) Capsules USP, 10 mg, 20 mg, and 40 mg. 076285........................... Simvastatin Tablets USP, 5 mg, 10 mg, 20 mg, 40 mg, and 80 mg. 076332........................... Fluconazole for Oral Suspension, 10 mg/mL and 40 mg/mL. 076409........................... Nefazodone Hydrochloride Tablets USP, 50 mg, 100 mg, 150 mg, 200 mg, and 250 mg. 076503........................... Sotret (isotretinoin) Capsules USP, 30 mg. 076606........................... Gabapentin Capsules USP, 100 mg, 300 mg, and 400 mg. 076739........................... Fosinopril Sodium and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg and 20 mg/12.5 mg. ------------------------------------------------------------------------ Therefore, under section 505(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(e)) and under authority delegated to the Director, Center for Drug Evaluation and Research, by the Commissioner, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn, effective January 19, 2017. Dated: December 15, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-30623 Filed 12-19-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 244 / Tuesday, December 20, 2016 / Notices 92821
DEPARTMENT OF HEALTH AND function. Appointments shall be made the authority to sign Federal Register
HUMAN SERVICES without discrimination on the basis of notices pertaining to announcements of
age, race, ethnicity, gender, sexual meetings and other committee
Centers for Disease Control and orientation, gender identity, HIV status, management activities for both the
Prevention disability, and cultural, religious, or Centers for Disease Control and
[Docket Number NIOSH 278] socioeconomic status. Nominees must Prevention, and the Agency for Toxic
be U.S. citizens, and cannot be full-time Substances and Disease Registry.
Request for Nominations of employees of the U.S. Government or
Catherine Ramadei,
Candidates To Serve on the Board of federally registered lobbyists. Current
participation on federal workgroups or Acting Director, Management Analysis and
Scientific Counselors (BSC), National Services Office, Centers for Disease Control
Institute for Occupational Safety and prior experience serving on a federal and Prevention.
Health (NIOSH) advisory committee does not disqualify
[FR Doc. 2016–30522 Filed 12–19–16; 8:45 am]
a candidate; however, HHS policy is to
The Centers for Disease Control and avoid excessive individual service on BILLING CODE 4163–18–P
Prevention (CDC) is soliciting advisory committees and multiple
nominations for possible membership
committee memberships. Board DEPARTMENT OF HEALTH AND
on the BSC, NIOSH.
members are Special Government
The BSC, NIOSH consists of 15 HUMAN SERVICES
experts in fields related to occupational Employees, requiring the filing of
safety and health. The members are financial disclosure reports at the Food and Drug Administration
selected by the Secretary of the U.S. beginning and annually during their
Department of Health and Human terms. CDC reviews potential candidates [Docket No. FDA–2016–N–4320]
Services (HHS). The board advises the for the Board membership each year,
and provides a slate of nominees for Sun Pharmaceutical Industries, Inc.;
NIOSH Director on occupational safety Withdrawal of Approval of 28
and health research and prevention consideration to the Secretary of HHS
for final selection. Abbreviated New Drug Applications
programs. The board also provides
advice on standards of scientific Candidates should submit the AGENCY: Food and Drug Administration,
excellence, current needs in the field of following items: HHS.
occupational safety and health, and the • Current curriculum vitae, including
complete contact information (name, ACTION: Notice.
applicability and dissemination of
research findings. This advice may take affiliation, mailing address, telephone SUMMARY: The Food and Drug
the form of reports or verbal number, email address) Administration (FDA) is withdrawing
communications to the NIOSH Director • A letter of recommendation stating approval of 28 abbreviated new drug
during BSC meetings. Nominations are the qualifications of the candidate. applications held by Sun
being sought for individuals who have Nominations must be submitted Pharmaceutical Industries, Inc. (Sun
expertise and qualifications necessary to (postmarked or electronically received) Pharmaceutical), U.S. Agent for Sun
contribute to the accomplishment of the by January 31, 2017. Pharmaceutical Industries Limited, 270
board’s mission. More information is Submissions must be electronic or by Prospect Plains Rd., Cranbury, NJ
available on the NIOSH BSC Web site: mail. Submissions should reference 08512. The drug products are no longer
http://www.cdc.gov/niosh/BSC/ docket 278. Electronic submissions: You marketed, and Sun Pharmaceutical has
default.html. may electronically submit nominations, requested that the approval of the
Nominees will be selected based on including attachments, to nioshdocket@ applications be withdrawn.
expertise in occupational safety and cdc.gov.
DATES: January 19, 2017.
health fields, such as occupational Attachments in Microsoft Word are
medicine, occupational nursing, preferred. Regular, Express, or FOR FURTHER INFORMATION CONTACT:
industrial hygiene, occupational safety Overnight Mail: Written nominations Florine P. Purdie, Center for Drug
and health engineering, toxicology, may be submitted (one original and two Evaluation and Research, Food and
chemistry, safety and health education, copies) to the following address only: Drug Administration, 10903 New
ergonomics, epidemiology, biostatistics, NIOSH Docket 278, c/o Richie Hampshire Ave., Bldg. 51, Rm. 6248,
and psychology. Members may be Dickerson, Committee Management Silver Spring, MD 20993–0002, 301–
invited to serve for terms of two to four Specialist, National Institute for 796–3601.
years. Selected nominees would begin Occupational Safety and Health, Centers SUPPLEMENTARY INFORMATION: The
service on the BSC, NIOSH in January for Disease Control and Prevention, applications listed in the table in this
2018. 1600 Clifton Road NE., MS: E–20, document are no longer marketed, and
The U.S. Department of Health and Atlanta, Georgia 30329. Telephone and Sun Pharmaceutical has requested that
Human Services policy stipulates that facsimile submissions cannot be FDA withdraw approval of the
committee membership shall be accepted. applications. The company has also, by
balanced in terms of points of view The Director, Management Analysis its request, waived its opportunity for a
represented, and the committee’s and Services Office, has been delegated hearing.
Application No. Drug
mstockstill on DSK3G9T082PROD with NOTICES
065007 ....................... Cephalexin Capsules USP, Equivalent to (EQ) 250 milligrams (mg) base and EQ 500 mg base.
065016 ....................... Amoxicillin Capsules USP, 250 mg and 500 mg.
065021 ....................... Amoxicillin Tablets USP (Chewable), 125 mg and 250 mg.
065059 ....................... Amoxicillin Tablets USP, 500 mg and 875 mg.
065060 ....................... Amoxicillin Tablets USP (Chewable), 200 mg and 400 mg.
065081 ....................... Cephalexin for Oral Suspension USP, EQ 125 mg base/5 milliliters (mL) and EQ 250 mg base/5 mL.
065082 ....................... Cefpodoxime Proxetil for Oral Suspension USP, EQ 50 mg base/5 mL and EQ 100 mg base/5 mL.
065083 ....................... Cefpodoxime Proxetil Tablets USP, EQ 100 mg base and EQ 200 mg base.
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![92822 Federal Register / Vol. 81, No. 244 / Tuesday, December 20, 2016 / Notices
Application No. Drug
065102 ....................... Amoxicillin and Clavulanate Potassium Tablets USP, 875 mg/EQ 125 mg base.
065109 ....................... Amoxicillin and Clavulanate Potassium Tablets USP, 500 mg/EQ 125 mg base.
065113 ....................... Amoxicillin for Oral Suspension USP, 200 mg/5 mL and 400 mg/5 mL.
065115 ....................... Cefadroxil for Oral Suspension USP, EQ 125 mg base/5 mL, EQ 250 mg base/5 mL, and EQ 500 mg base/5 mL.
065118 ....................... Cefuroxime Axetil Tablets USP, EQ 125 mg base, EQ 250 mg base, and EQ 500 mg base.
065132 ....................... Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 200 mg/EQ 28.5 mg base per 5 mL and 400 mg/EQ
57 mg base per 5 mL.
065161 ....................... Amoxicillin and Clavulanate Potassium Tablets USP (Chewable), 200 mg/EQ 28.5 mg base and 400 mg/EQ 57 mg
base.
065207 ....................... Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 600 mg/EQ 42.9 mg base per 5 mL.
065323 ....................... Cefuroxime Axetil for Oral Suspension USP, EQ 125 mg base/5 mL and EQ 250 mg base/5 mL.
074975 ....................... Acyclovir Capsules USP, 200 mg.
074980 ....................... Acyclovir Tablets USP, 400 mg and 800 mg.
075132 ....................... Ranitidine Tablets USP, EQ 75 mg base.
075439 ....................... Ranitidine Tablets USP, EQ 150 mg base and EQ 300 mg base.
076041 ....................... Sotret (isotretinoin) Capsules USP, 10 mg, 20 mg, and 40 mg.
076285 ....................... Simvastatin Tablets USP, 5 mg, 10 mg, 20 mg, 40 mg, and 80 mg.
076332 ....................... Fluconazole for Oral Suspension, 10 mg/mL and 40 mg/mL.
076409 ....................... Nefazodone Hydrochloride Tablets USP, 50 mg, 100 mg, 150 mg, 200 mg, and 250 mg.
076503 ....................... Sotret (isotretinoin) Capsules USP, 30 mg.
076606 ....................... Gabapentin Capsules USP, 100 mg, 300 mg, and 400 mg.
076739 ....................... Fosinopril Sodium and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg and 20 mg/12.5 mg.
Therefore, under section 505(e) of the emergency use of the authorized in vitro 4347, Silver Spring, MD 20993–0002,
Federal Food, Drug, and Cosmetic Act diagnostic device. The Authorization 301–796–8510 (this is not a toll free
(21 U.S.C. 355(e)) and under authority follows the February 26, 2016, number).
delegated to the Director, Center for determination by the Secretary of Health SUPPLEMENTARY INFORMATION:
Drug Evaluation and Research, by the and Human Services (HHS) that there is
Commissioner, approval of the a significant potential for a public I. Background
applications listed in the table, and all health emergency that has a significant Section 564 of the FD&C Act (21
amendments and supplements thereto, potential to affect national security or U.S.C. 360bbb–3) as amended by the
is hereby withdrawn, effective January the health and security of U.S. citizens Project BioShield Act of 2004 (Pub L.
19, 2017. living abroad and that involves Zika 108–276) and the Pandemic and All-
Dated: December 15, 2016. virus. On the basis of such Hazards Preparedness Reauthorization
Leslie Kux,
determination, the Secretary of HHS Act of 2013 (Pub L. 113–5) allows FDA
declared on February 26, 2016, that to strengthen the public health
Associate Commissioner for Policy.
circumstances exist justifying the protections against biological, chemical,
[FR Doc. 2016–30623 Filed 12–19–16; 8:45 am]
authorization of emergency use of in nuclear, and radiological agents. Among
BILLING CODE 4164–01–P vitro diagnostic tests for detection of other things, section 564 of the FD&C
Zika virus and/or diagnosis of Zika Act allows FDA to authorize the use of
virus infection, subject to the terms of an unapproved medical product or an
DEPARTMENT OF HEALTH AND
any authorization issued under the unapproved use of an approved medical
HUMAN SERVICES
FD&C Act. The Authorization, which product in certain situations. With this
Food and Drug Administration includes an explanation of the reasons EUA authority, FDA can help assure
for issuance, is reprinted in this that medical countermeasures may be
[Docket No. FDA–2016–N–0969] document. used in emergencies to diagnose, treat,
Authorization of Emergency Use of an DATES: The Authorization is effective as or prevent serious or life-threatening
In Vitro Diagnostic Device for of November 21, 2016. diseases or conditions caused by
Detection of Zika Virus; Availability biological, chemical, nuclear, or
ADDRESSES: Submit written requests for
radiological agents when there are no
single copies of the EUA to the Office
AGENCY: Food and Drug Administration, adequate, approved, and available
of Counterterrorism and Emerging
HHS. alternatives.
Threats, Food and Drug Administration, Section 564(b)(1) of the FD&C Act
ACTION: Notice. 10903 New Hampshire Ave., Bldg. 1, provides that, before an EUA may be
SUMMARY: The Food and Drug Rm. 4338, Silver Spring, MD 20993– issued, the Secretary of HHS must
Administration (FDA) is announcing the 0002. Send one self-addressed adhesive declare that circumstances exist
issuance of an Emergency Use label to assist that office in processing justifying the authorization based on
Authorization (EUA) (the Authorization) your request or include a fax number to one of the following grounds: (1) A
for an in vitro diagnostic device for which the Authorization may be sent. determination by the Secretary of
detection of the Zika virus in response See the SUPPLEMENTARY INFORMATION Homeland Security that there is a
mstockstill on DSK3G9T082PROD with NOTICES
to the Zika virus outbreak in the section for electronic access to the domestic emergency, or a significant
Americas. FDA issued this Authorization. potential for a domestic emergency,
Authorization under the Federal Food, FOR FURTHER INFORMATION CONTACT: involving a heightened risk of attack
Drug, and Cosmetic Act (the FD&C Act), Carmen Maher, Office of with a biological, chemical, radiological,
as requested by Abbott Molecular, Inc. Counterterrorism and Emerging Threats, or nuclear agent or agents; (2) a
The Authorization contains, among Food and Drug Administration, 10903 determination by the Secretary of
other things, conditions on the New Hampshire Ave., Bldg. 1, Rm. Defense that there is a military
VerDate Sep<11>2014 19:36 Dec 19, 2016 Jkt 241001 PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 E:\FR\FM\20DEN1.SGM 20DEN1](https://thefederalregister.org/doc/81_FR_93065/page/2.svg)
Document Created: 2018-02-14 09:10:19
Document Modified: 2018-02-14 09:10:19
| 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. | |
| Dates | January 19, 2017. | |
| Contact | Florine P. Purdie, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6248, Silver Spring, MD 20993-0002, 301- 796-3601. | |
| FR Citation | 81 FR 92821 |
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