83 FR 6192 - Mallinkrodt Pharmaceuticals LLC; Withdrawal of Approval of an Abbreviated New Drug Application for PEMOLINE Tablets, 18.75 Milligrams, 37.5 Milligrams, and 75 Milligrams
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 30 (February 13, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 30 (February 13, 2018)
| Page Range | 6192-6192 | |
| FR Document | 2018-02925 |
[Federal Register Volume 83, Number 30 (Tuesday, February 13, 2018)] [Notices] [Page 6192] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-02925] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-0409] Mallinkrodt Pharmaceuticals LLC; Withdrawal of Approval of an Abbreviated New Drug Application for PEMOLINE Tablets, 18.75 Milligrams, 37.5 Milligrams, and 75 Milligrams AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is withdrawing the approval of abbreviated new drug application (ANDA) 075726 for PEMOLINE Tablets, 18.75 milligrams (mg), 37.5 mg, and 75 mg, held by Mallinkrodt Pharmaceuticals, LLC (Mallinkrodt). Mallinkrodt requested withdrawal of this application and has waived its opportunity for a hearing. DATES: Approval is withdrawn as of February 13, 2018. FOR FURTHER INFORMATION CONTACT: Kristiana Brugger, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6262, Silver Spring, MD 20993, 301-796- 3600. SUPPLEMENTARY INFORMATION: FDA approved ANDA 075726 for PEMOLINE Tablets, 18.75 mg, 37.5 mg, and 75 mg, on March 30, 2001, for the conditions of use in the labeling of new drug application (NDA) 016832, the reference listed drug on which it relied. However, on October 24, 2005, FDA announced its concern that the overall liver toxicity risk of CYLERT (NDA 016832) and generic pemoline products outweighed the benefits of these products. Mallinkrodt and other holders of approved applications for PEMOLINE products ceased marketing them at that time. Indeed, Mallinkrodt stated in its May 15, 2013, request for withdrawal of approval of ANDA 075726 that it had never manufactured or distributed its product after it received approval of its application. In the Federal Register of October 4, 2016 (81 FR 68427), FDA erroneously included ANDA 075726 in a list of drug applications for which approval was being withdrawn under Sec. 314.150(c) (21 CFR 314.150(c)). In a separate notice published in this issue of the Federal Register, FDA corrects that notice to remove ANDA 075726 from the list of applications whose approval was withdrawn under Sec. 314.150(c). In addition, for the reasons discussed above, and pursuant to Mallinkrodt's request, FDA is withdrawing approval of ANDA 075726, and all amendments and supplements thereto, under Sec. 314.150(d). Distribution of PEMOLINE Tablets, 18.75 mg, 37.5 mg, and 75 mg, in interstate commerce without an approved application is illegal and subject to regulatory action (see sections 505(a) and 301(d) of the FD&C Act (21 U.S.C. 355(a) and 331(d)). Dated: February 8, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-02925 Filed 2-12-18; 8:45 am] BILLING CODE 4164-01-P
![6192 Federal Register / Vol. 83, No. 30 / Tuesday, February 13, 2018 / Notices
The number of respondents to be time. Indeed, Mallinkrodt stated in its redetermination by April 16, 2018.
included in each new survey will vary, May 15, 2013, request for withdrawal of Furthermore, any interested person may
depending on the nature of the material approval of ANDA 075726 that it had petition FDA for a determination
or message being tested and the target never manufactured or distributed its regarding whether the applicant for
audience. The burden for this product after it received approval of its extension acted with due diligence
information collection extension is application. during the regulatory review period by
proposed to increase by 12,613 hours In the Federal Register of October 4, August 13, 2018. See ‘‘Petitions’’ in the
since the last OMB approval. The 2016 (81 FR 68427), FDA erroneously SUPPLEMENTARY INFORMATION section for
burden increase is due to an increase in included ANDA 075726 in a list of drug more information.
the number of respondents and the applications for which approval was ADDRESSES: You may submit comments
categories of respondents. being withdrawn under § 314.150(c) (21 as follows. Please note that late,
Dated: February 7, 2018. CFR 314.150(c)). In a separate notice untimely filed comments will not be
Leslie Kux, published in this issue of the Federal considered. Electronic comments must
Associate Commissioner for Policy.
Register, FDA corrects that notice to be submitted on or before April 16,
remove ANDA 075726 from the list of 2018. The https://www.regulations.gov
[FR Doc. 2018–02852 Filed 2–12–18; 8:45 am]
applications whose approval was electronic filing system will accept
BILLING CODE 4164–01–P
withdrawn under § 314.150(c). In comments until midnight Eastern Time
addition, for the reasons discussed at the end of April 16, 2018. Comments
DEPARTMENT OF HEALTH AND above, and pursuant to Mallinkrodt’s received by mail/hand delivery/courier
HUMAN SERVICES request, FDA is withdrawing approval (for written/paper submissions) will be
of ANDA 075726, and all amendments considered timely if they are
Food and Drug Administration and supplements thereto, under postmarked or the delivery service
§ 314.150(d). Distribution of PEMOLINE acceptance receipt is on or before that
[Docket No. FDA–2018–N–0409] Tablets, 18.75 mg, 37.5 mg, and 75 mg, date.
Mallinkrodt Pharmaceuticals LLC; in interstate commerce without an
Electronic Submissions
Withdrawal of Approval of an approved application is illegal and
subject to regulatory action (see sections Submit electronic comments in the
Abbreviated New Drug Application for following way:
PEMOLINE Tablets, 18.75 Milligrams, 505(a) and 301(d) of the FD&C Act (21
U.S.C. 355(a) and 331(d)). • Federal eRulemaking Portal:
37.5 Milligrams, and 75 Milligrams https://www.regulations.gov. Follow the
Dated: February 8, 2018. instructions for submitting comments.
AGENCY: Food and Drug Administration, Leslie Kux,
HHS. Comments submitted electronically,
Associate Commissioner for Policy. including attachments, to https://
ACTION: Notice.
[FR Doc. 2018–02925 Filed 2–12–18; 8:45 am] www.regulations.gov will be posted to
SUMMARY: The Food and Drug BILLING CODE 4164–01–P the docket unchanged. Because your
Administration (FDA) is withdrawing comment will be made public, you are
the approval of abbreviated new drug solely responsible for ensuring that your
application (ANDA) 075726 for DEPARTMENT OF HEALTH AND comment does not include any
PEMOLINE Tablets, 18.75 milligrams HUMAN SERVICES confidential information that you or a
(mg), 37.5 mg, and 75 mg, held by third party may not wish to be posted,
Mallinkrodt Pharmaceuticals, LLC Food and Drug Administration such as medical information, your or
(Mallinkrodt). Mallinkrodt requested [Docket No. FDA–2013–E–0780] anyone else’s Social Security number, or
withdrawal of this application and has confidential business information, such
waived its opportunity for a hearing. Determination of Regulatory Review as a manufacturing process. Please note
DATES: Approval is withdrawn as of Period for Purposes of Patent that if you include your name, contact
February 13, 2018. Extension; VASCEPA information, or other information that
FOR FURTHER INFORMATION CONTACT: AGENCY: Food and Drug Administration, identifies you in the body of your
Kristiana Brugger, Center for Drug HHS. comments, that information will be
Evaluation and Research, Food and posted on https://www.regulations.gov.
ACTION: Notice. • If you want to submit a comment
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6262, SUMMARY: The Food and Drug with confidential information that you
Silver Spring, MD 20993, 301–796– Administration (FDA or the Agency) has do not wish to be made available to the
3600. determined the regulatory review period public, submit the comment as a
for VASCEPA and is publishing this written/paper submission and in the
SUPPLEMENTARY INFORMATION: FDA manner detailed (see ‘‘Written/Paper
approved ANDA 075726 for PEMOLINE notice of that determination as required
by law. FDA has made the Submissions’’ and ‘‘Instructions’’).
Tablets, 18.75 mg, 37.5 mg, and 75 mg,
on March 30, 2001, for the conditions of determination because of the Written/Paper Submissions
use in the labeling of new drug submission of an application to the
Submit written/paper submissions as
application (NDA) 016832, the reference Director of the U.S. Patent and
follows:
listed drug on which it relied. However, Trademark Office (USPTO), Department • Mail/Hand delivery/Courier (for
on October 24, 2005, FDA announced its of Commerce, for the extension of a
sradovich on DSK3GMQ082PROD with NOTICES
written/paper submissions): Dockets
concern that the overall liver toxicity patent which claims that human drug Management Staff (HFA–305), Food and
risk of CYLERT (NDA 016832) and product. Drug Administration, 5630 Fishers
generic pemoline products outweighed DATES: Anyone with knowledge that any Lane, Rm. 1061, Rockville, MD 20852.
the benefits of these products. of the dates as published (in the • For written/paper comments
Mallinkrodt and other holders of SUPPLEMENTARY INFORMATION section) are submitted to the Dockets Management
approved applications for PEMOLINE incorrect may submit either electronic Staff, FDA will post your comment, as
products ceased marketing them at that or written comments and ask for a well as any attachments, except for
VerDate Sep<11>2014 23:12 Feb 12, 2018 Jkt 244001 PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 E:\FR\FM\13FEN1.SGM 13FEN1](https://thefederalregister.org/doc/83_FR_6222/page/1.svg)
Document Created: 2018-02-13 02:32:09
Document Modified: 2018-02-13 02:32:09
| 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 | Approval is withdrawn as of February 13, 2018. | |
| Contact | Kristiana Brugger, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6262, Silver Spring, MD 20993, 301-796- 3600. | |
| FR Citation | 83 FR 6192 |
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