[Federal Register Volume 85, Number 178 (Monday, September 14, 2020)]
[Notices]
[Page 56634]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-20161]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-711]


Importer of Controlled Substances Application: Novitium Pharma 
LLC

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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SUMMARY: Novitium Pharma LLC has applied to be registered as an 
importer of basic class(es) of controlled substance(s). Refer to 
Supplemental Information listed below for further drug(s) information.

DATES: Registered bulk manufacturers of the affected basic class(es), 
and applicants therefore, may file written comments on or objections to 
the issuance of the proposed registration on or before October 14, 
2020. Such persons may also file a written request for a hearing on the 
application on or before October 14, 2020.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DPW, 
8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a 
hearing must be sent to: Drug Enforcement Administration, Attn: 
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All 
requests for a hearing should also be sent to: (1) Drug Enforcement 
Administration, Attn: Hearing Clerk/OALJ, 8701 Morrissette Drive, 
Springfield, Virginia 22152; and (2) Drug Enforcement Administration, 
Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, 
Springfield, Virginia 22152.

SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this 
is notice that on August 18, 2020, Novitium Pharma LLC, 70 Lake Drive, 
East Windsor, New Jersey 08520, applied to be registered as an importer 
of the following basic class(es) of controlled substance(s):

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         Controlled substance            Drug code        Schedule
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Lisdexamfetamine......................        1205  II
Levorphanol...........................        9220  II
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    The company plans to import the listed controlled substance 
Lisdexamfetamine as a raw Active Pharmaceutical Ingredients (API) 
material for drug product development and research purposes only. The 
company may import Lisdexamfetamine API for research purposes only but 
not for the manufacturing of Food and Drug Administration (FDA)-
approved products.
    The company plans to import the listed controlled substance 
Levorphanol to develop the manufacturing process for a drug product 
that will in turn be used to produce a tablet equivalent to the current 
brand product.
    Approval of permit applications will occur only when the 
registrant's business activity is consistent with what is authorized 
under 21 U.S.C. 952(a)(2). Authorization will not extend to the import 
of FDA-approved or non-approved finished dosage forms for commercial 
sale.

William T. McDermott,
Assistant Administrator.
[FR Doc. 2020-20161 Filed 9-11-20; 8:45 am]
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