81 FR 96004 - Abbott Laboratories, et al.; Withdrawal of Approval of Four New Drug Applications and Two Abbreviated New Drug Applications
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 250 (December 29, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 250 (December 29, 2016)
| Page Range | 96004-96005 | |
| FR Document | 2016-31625 |
[Federal Register Volume 81, Number 250 (Thursday, December 29, 2016)] [Notices] [Pages 96004-96005] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-31625] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-0002] Abbott Laboratories, et al.; Withdrawal of Approval of Four New Drug Applications and Two Abbreviated New Drug Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval of four new drug applications (NDAs) and two abbreviated new drug applications (ANDAs) from multiple applicants. The holders of the applications notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn. DATES: Effective Date: January 30, 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 holders of the applications listed in the table have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications pursuant to the process in Sec. 314.150(c) (21 CFR 314.150(c)). The applicants have also, by their requests, waived their opportunity for a hearing. Withdrawal of approval of an application or abbreviated application under Sec. 314.150(c) is without prejudice to refiling. [[Page 96005]] ------------------------------------------------------------------------ Application No. Drug Applicant ------------------------------------------------------------------------ NDA 019080.................. ProSom (estazolam) Abbott Laboratories, Tablets, 1 200 Abbott Park milligram (mg) and Rd., Abbott Park, 2 mg. IL 60064. NDA 020195.................. Fentanyl Oralet Cephalon, Inc., 41 (fentanyl citrate) Moores Rd., Frazer, Troche/Lozenge, PA 19355. Equivalent to (EQ) 0.1 mg base, EQ 0.2 mg base, EQ 0.3 mg base, and EQ 0.4 mg base. NDA 021726.................. Niravam (alprazolam) UCB, Inc., 1950 Lake Orally Park Dr., Building Disintegrating 2100, Smyrna, GA Tablets, 0.25 mg, 30080. 0.5 mg, 1 mg, and 2 mg. ANDA 084287................. Methyltestosterone Impax Laboratories, Tablets USP, 10 mg. Inc., 31047 Genstar Rd., Hayward, CA 94544. ANDA 084310................. Methyltestosterone Do. Tablets USP, 25 mg. NDA 205208.................. Desvenlafaxine Teva Pharmaceuticals Fumarate Extended- USA, Inc., 425 Release Tablets, EQ Privet Rd., 50 mg base and EQ Horsham, PA 19044. 100 mg base. ------------------------------------------------------------------------ Therefore, under section 505(e) of the Federal Food, Drug, and Cosmetic Act (FD&C 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 30, 2017. Introduction or delivery for introduction into interstate commerce of products without approved new drug applications violates section 301(a) and (d) of the FD&C Act (21 U.S.C. 331(a) and (d)). Drug products that are listed in the table that are in inventory on the date that this notice becomes effective (see the DATES section) may continue to be dispensed until the inventories have been depleted or the drug products have reached their expiration dates or otherwise become violative, whichever occurs first. Dated: December 23, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-31625 Filed 12-28-16; 8:45 am] BILLING CODE 4164-01-P
![96004 Federal Register / Vol. 81, No. 250 / Thursday, December 29, 2016 / Notices
SUPPLEMENTARY INFORMATION: market as of June 22, 2009, the list of information in section 904(a)(1) of the
ingredients had to be submitted by FD&C Act have been approved under
I. Background
December 22, 2009. For cigarettes, OMB control number 0910–0650.
We are announcing the availability of cigarette tobacco, RYO, and smokeless
a revised guidance for industry entitled IV. Electronic Access
tobacco products not on the market as
‘‘Listing of Ingredients in Tobacco of June 22, 2009, section 904(c)(1) Persons with access to the Internet
Products.’’ We are issuing this guidance requires that the list of ingredients be may obtain an electronic version of the
consistent with our good guidance submitted at least 90 days prior to revised guidance at either https://
practices regulation (21 CFR 10.115). delivery for introduction into interstate www.regulations.gov or http://
The revised guidance document is commerce. Section 904(c) of the FD&C www.fda.gov/TobaccoProducts/
intended to assist persons making Act also requires submission of Labeling/RulesRegulationsGuidance/
tobacco product ingredient submissions information whenever any additive, or default.htm.
to FDA as required by the Tobacco the quantity of any additive, is changed. Dated: December 23, 2016.
Control Act. As described in the preamble to the
The Tobacco Control Act (Pub. L. Leslie Kux,
final deeming rule, for products other
111–31), enacted on June 22, 2009, Associate Commissioner for Policy.
than cigarettes, cigarette tobacco, RYO,
amends the Federal Food, Drug, and [FR Doc. 2016–31587 Filed 12–28–16; 8:45 am]
and smokeless tobacco that are on the
Cosmetic Act (the FD&C Act) and market as of August 8, 2016, FDA does BILLING CODE 4164–01–P
provides FDA with the authority to not intend to enforce the section
regulate the manufacture, marketing, 904(a)(1) ingredient listing submission
and distribution of tobacco products to DEPARTMENT OF HEALTH AND
requirement until 6 months from the
protect the public health. Among its HUMAN SERVICES
effective date of the rule or 12 months
many provisions, the Tobacco Control from the effective date for small-scale Food and Drug Administration
Act added section 904 to the FD&C Act tobacco product manufacturers.
(21 U.S.C. 387d), establishing However, in the revised guidance, FDA
requirements for tobacco product [Docket No. FDA–2016–N–0002]
is announcing an additional 6-month
ingredient submissions. compliance policy for newly deemed
The revised guidance discusses Abbott Laboratories, et al.; Withdrawal
tobacco products on the market as of of Approval of Four New Drug
tobacco products that are newly deemed August 8, 2016. Under this policy, FDA
subject to chapter IX of the FD&C Act. Applications and Two Abbreviated
will not enforce the ingredient listing New Drug Applications
Cigarettes, cigarette tobacco, roll-your- submission requirement until August 8,
own tobacco (RYO), and smokeless 2017, for businesses that are not AGENCY: Food and Drug Administration,
tobacco were immediately covered by considered small-scale tobacco product HHS.
FDA’s tobacco product authorities in manufactures, and February 8, 2018, for ACTION: Notice.
chapter IX of the FD&C Act, including small-scale tobacco product
section 904, when the Tobacco Control manufacturers. Manufacturers of SUMMARY: The Food and Drug
Act went into effect. As for other types tobacco products introduced into Administration (FDA) is withdrawing
of tobacco products, section 901(b) of interstate commerce after August 8, approval of four new drug applications
the FD&C Act (21 U.S.C. 387a) grants 2016, must submit the ingredient (NDAs) and two abbreviated new drug
FDA authority to deem those products information required by section applications (ANDAs) from multiple
subject to chapter IX of the FD&C Act. 904(a)(1) at least 90 days before the applicants. The holders of the
Under that authority, FDA issued a rule product is delivered for introduction applications notified the Agency in
deeming all other products that meet the into interstate commerce, as with writing that the drug products were no
statutory definition of ‘‘tobacco cigarettes, cigarette tobacco, RYO, and longer marketed and requested that the
product’’, set forth in section 201(rr) of smokeless tobacco first marketed after approval of the applications be
the FD&C Act (21 U.S.C. 321(rr)), except June 22, 2009 (section 904(c)(1) of the withdrawn.
for accessories of those products, as FD&C Act). DATES: Effective Date: January 30, 2017.
subject to chapter IX of the FD&C Act
(81 FR 28974). FDA published the final II. Significance of Guidance FOR FURTHER INFORMATION CONTACT:
rule on May 10, 2016 and it became FDA is issuing this revised guidance Florine P. Purdie, Center for Drug
effective on August 8, 2016. As a result, consistent with FDA’s good guidance Evaluation and Research, Food and
manufacturers or importers (or their practices regulation (21 CFR 10.115). Drug Administration, 10903 New
agents) of tobacco products subject to The guidance represents the current Hampshire Ave., Bldg. 51, Rm. 6248,
the deeming rule are now required to thinking of FDA on ingredient listing. It Silver Spring, MD 20993–0002, 301–
comply with chapter IX of the FD&C does not establish any rights for any 796–3601.
Act, including the ingredient listing person and is not binding on FDA or the SUPPLEMENTARY INFORMATION: The
requirements in section 904(a)(1). public. You can use an alternative holders of the applications listed in the
Section 904(a)(1) of the FD&C Act approach if it satisfies the requirements table have informed FDA that these drug
requires each tobacco product of the applicable statutes and products are no longer marketed and
manufacturer or importer, or agent regulations. have requested that FDA withdraw
asabaliauskas on DSK3SPTVN1PROD with NOTICES
thereof, to submit a listing of all approval of the applications pursuant to
ingredients, including tobacco, III. Paperwork Reduction Act of 1995 the process in § 314.150(c) (21 CFR
substances, compounds, and additives This revised guidance also refers to 314.150(c)). The applicants have also,
that are added by the manufacturer to previously approved collections of by their requests, waived their
the tobacco, paper, filter, or other part information found in FDA regulations. opportunity for a hearing. Withdrawal
of each tobacco product by brand and by The revised draft guidance includes of approval of an application or
quantity in each brand and subbrand. information and recommendations for abbreviated application under
For cigarettes, cigarette tobacco, RYO, how to provide ingredient listing § 314.150(c) is without prejudice to
and smokeless tobacco products on the submissions. The collections of refiling.
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![Federal Register / Vol. 81, No. 250 / Thursday, December 29, 2016 / Notices 96005
Application No. Drug Applicant
NDA 019080 ........................ ProSom (estazolam) Tablets, 1 milligram (mg) and 2 Abbott Laboratories, 200 Abbott Park Rd., Abbott Park,
mg. IL 60064.
NDA 020195 ........................ Fentanyl Oralet (fentanyl citrate) Troche/Lozenge, Cephalon, Inc., 41 Moores Rd., Frazer, PA 19355.
Equivalent to (EQ) 0.1 mg base, EQ 0.2 mg base,
EQ 0.3 mg base, and EQ 0.4 mg base.
NDA 021726 ........................ Niravam (alprazolam) Orally Disintegrating Tablets, UCB, Inc., 1950 Lake Park Dr., Building 2100, Smyrna,
0.25 mg, 0.5 mg, 1 mg, and 2 mg. GA 30080.
ANDA 084287 ...................... Methyltestosterone Tablets USP, 10 mg ........................ Impax Laboratories, Inc., 31047 Genstar Rd., Hayward,
CA 94544.
ANDA 084310 ...................... Methyltestosterone Tablets USP, 25 mg ........................ Do.
NDA 205208 ........................ Desvenlafaxine Fumarate Extended-Release Tablets, Teva Pharmaceuticals USA, Inc., 425 Privet Rd.,
EQ 50 mg base and EQ 100 mg base. Horsham, PA 19044.
Therefore, under section 505(e) of the sets forth FDA’s policy regarding comments, that information will be
Federal Food, Drug, and Cosmetic Act compounding and repackaging of posted on https://www.regulations.gov.
(FD&C Act) (21 U.S.C. 355(e)) and under radiopharmaceuticals for human use by • If you want to submit a comment
authority delegated to the Director, entities that are registered with FDA as with confidential information that you
Center for Drug Evaluation and outsourcing facilities. This guidance do not wish to be made available to the
Research, by the Commissioner, describes how FDA intends to apply public, submit the comment as a
approval of the applications listed in the section 503B of the Federal Food, Drug, written/paper submission and in the
table, and all amendments and and Cosmetic Act (the FD&C Act) to manner detailed (see ‘‘Written/Paper
supplements thereto, is hereby radiopharmaceuticals compounded by Submissions’’ and ‘‘Instructions’’).
withdrawn, effective January 30, 2017. outsourcing facilities, and it describes Written/Paper Submissions
Introduction or delivery for introduction the conditions under which FDA does
into interstate commerce of products not intend to take action for violations Submit written/paper submissions as
without approved new drug of certain provisions of the FD&C Act follows:
applications violates section 301(a) and when an outsourcing facility repackages • Mail/Hand delivery/Courier (for
written/paper submissions): Division of
(d) of the FD&C Act (21 U.S.C. 331(a) radiopharmaceuticals.
Dockets Management (HFA–305), Food
and (d)). Drug products that are listed in DATES: Although you can comment on and Drug Administration, 5630 Fishers
the table that are in inventory on the any guidance at any time (see 21 CFR Lane, Rm. 1061, Rockville, MD 20852.
date that this notice becomes effective 10.115(g)(5)), to ensure that the Agency • For written/paper comments
(see the DATES section) may continue to considers your comment on this draft submitted to the Division of Dockets
be dispensed until the inventories have guidance before it begins work on the Management, FDA will post your
been depleted or the drug products have final version of the guidance, submit comment, as well as any attachments,
reached their expiration dates or either electronic or written comments except for information submitted,
otherwise become violative, whichever on the draft guidance by February 27, marked and identified, as confidential,
occurs first. 2017. Submit either electronic or if submitted as detailed in
Dated: December 23, 2016. written comments concerning the ‘‘Instructions.’’
Leslie Kux, collection of information proposed in Instructions: All submissions received
Associate Commissioner for Policy. the draft guidance by February 27, 2017. must include the Docket No. FDA–
[FR Doc. 2016–31625 Filed 12–28–16; 8:45 am] 2016–D–4317 for ‘‘Compounding and
ADDRESSES: You may submit comments
Repackaging of Radiopharmaceuticals
BILLING CODE 4164–01–P as follows: by Outsourcing Facilities.’’ Received
Electronic Submissions comments will be placed in the docket
DEPARTMENT OF HEALTH AND and, except for those submitted as
Submit electronic comments in the ‘‘Confidential Submissions,’’ publicly
HUMAN SERVICES following way: viewable at http://www.regulations.gov
Food and Drug Administration • Federal eRulemaking Portal: or at the Division of Dockets
https://www.regulations.gov. Follow the Management between 9 a.m. and 4 p.m.,
[Docket No. FDA–2016–D–4317] instructions for submitting comments. Monday through Friday.
Comments submitted electronically, • Confidential Submissions—To
Compounding and Repackaging of
including attachments, to https:// submit a comment with confidential
Radiopharmaceuticals by Outsourcing
www.regulations.gov will be posted to information that you do not wish to be
Facilities; Draft Guidance for Industry;
the docket unchanged. Because your made publicly available, submit your
Availability
comment will be made public, you are comments only as a written/paper
AGENCY: Food and Drug Administration, solely responsible for ensuring that your submission. You should submit two
HHS. comment does not include any copies total. One copy will include the
confidential information that you or a information you claim to be confidential
asabaliauskas on DSK3SPTVN1PROD with NOTICES
ACTION: Notice.
third party may not wish to be posted, with a heading or cover note that states
SUMMARY: The Food and Drug such as medical information, your or ‘‘THIS DOCUMENT CONTAINS
Administration (FDA or Agency) is anyone else’s Social Security number, or CONFIDENTIAL INFORMATION.’’ The
announcing the availability of a draft confidential business information, such Agency will review this copy, including
guidance for industry entitled as a manufacturing process. Please note the claimed confidential information, in
‘‘Compounding and Repackaging of that if you include your name, contact its consideration of comments. The
Radiopharmaceuticals by Outsourcing information, or other information that second copy, which will have the
Facilities.’’ Specifically, this guidance identifies you in the body of your claimed confidential information
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Document Created: 2016-12-29 01:58:41
Document Modified: 2016-12-29 01:58:41
| 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 | Effective Date: January 30, 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 96004 |
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