Notice2022-04061
Importer of Controlled Substances Application: Lyndra Therapeutics
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
February 25, 2022
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
Lyndra Therapeutics 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 information.
Full Text
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<title>Federal Register, Volume 87 Issue 38 (Friday, February 25, 2022)</title>
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[Federal Register Volume 87, Number 38 (Friday, February 25, 2022)]
[Notices]
[Page 10823]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-04061]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-965]
Importer of Controlled Substances Application: Lyndra
Therapeutics
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
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SUMMARY: Lyndra Therapeutics 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 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 March 28, 2022.
Such persons may also file a written request for a hearing on the
application on or before March 28, 2022.
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 January 13, 2022, Lyndra Therapeutics, 65 Grove
Street, Suite 301, Watertown, Massachusetts 02472, applied to be
registered as an importer of the following basic class(es) of
controlled substance(s):
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Drug
Controlled substance code Schedule
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Methadone.............................. 9250 II
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The company plans to develop the formulation and process, and then
manufacture the finished oral dosage form for use in preclinical and
human clinical trials and analysis. No other activity for this drug
code is authorized for this registration.
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 Food and Drug Administration-approved or non-approved finished
dosage forms for commercial sale.
Matthew J. Strait,
Deputy Assistant Administrator.
[FR Doc. 2022-04061 Filed 2-24-22; 8:45 am]
BILLING CODE 4410-09-P
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</html>Indexed from Federal Register on February 25, 2022.
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