[Federal Register Volume 84, Number 179 (Monday, September 16, 2019)]
[Notices]
[Page 48625]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-19908]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-3839]
Impax Laboratories, LLC; Withdrawal of Approval of an Abbreviated
New Drug Application for Ursodiol Capsules USP, 300 Milligrams
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing the approval of abbreviated new drug application (ANDA)
077895 for Ursodiol Capsules USP, 300 milligrams (mg), held by Impax
Laboratories, LLC (Impax). Impax requested withdrawal of this
application and has waived its opportunity for a hearing.
DATES: Approval is withdrawn as of September 16, 2019.
FOR FURTHER INFORMATION CONTACT: Jennifer Forde, Office of Regulatory
Policy, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6228, Silver
Spring, MD 20993-0002, 301-348-3035.
SUPPLEMENTARY INFORMATION: On July 27, 2006, FDA approved ANDA 077895
for Ursodiol Capsules USP, 300 mg, submitted by CorePharma, LLC
(CorePharma). According to annual reports filed with the Agency, this
product has not been commercially manufactured since February 2010.
In a letter dated August 9, 2011, FDA informed CorePharma that it
had concerns about the validity of bioequivalence data submitted with
ANDA 077895 from studies conducted by a certain contract research
organization intended to establish bioequivalence of CorePharma's
product to its reference listed drug (RLD), new drug application
019594, Actigall (Ursodiol) Capsules, 300 mg. In that letter, FDA
directed CorePharma to supplement its ANDA with either: (1) New
bioequivalence studies or (2) re-assays of the samples from the
original bioequivalence studies. In a letter dated January 26, 2012,
CorePharma submitted a request for an extension of time to submit new
bioequivalence data in response to the Agency's August 9, 2011, letter.
On February 10, 2012, the Agency granted CorePharma's request for an
extension to submit new bioequivalence data by October 30, 2012.
FDA subsequently sent another letter to CorePharma on August 19,
2016, requesting that CorePharma provide the requested bioequivalence
data within 30 calendar days or voluntarily seek withdrawal of ANDA
077895 under Sec. 314.150(d) (21 CFR 314.150(d)). In response to the
August 19, 2016, correspondence, FDA received a letter from CorePharma
dated September 7, 2016, stating that CorePharma did not wish to
request the withdrawal of approval of ANDA 077895 for Ursodiol
Capsules. In February 2017, the Agency was notified that the ownership
of ANDA 077895 was transferred from CorePharma to Impax.
On April 24, 2017, FDA issued a letter to Impax, noting that as of
the date of the April 24, 2017, letter, FDA had not received the
requested bioequivalence data. In the April 24, 2017, correspondence,
FDA strongly suggested to Impax that it voluntarily seek withdrawal of
ANDA 077895 under Sec. 314.150(d) as a result of failing to provide
data and information establishing bioequivalence to the RLD. In a
letter dated February 25, 2019, Impax informed FDA that it would like
to request the withdrawal of ANDA 077895 under Sec. 314.150(d).
Additionally, in a March 14, 2019, correspondence to FDA, Impax waived
any opportunity for hearing provided under Sec. 314.150(a).
In the Federal Register of February 5, 2019 (84 FR 1745), FDA
erroneously included ANDA 077895 in a list of drug applications for
which approval was being withdrawn under Sec. 314.150(c). Elsewhere in
this issue of the Federal Register FDA is publishing a correction to
that notice to remove ANDA 077895 from the list of applications whose
approval was withdrawn under Sec. 314.150(c). In addition, for the
reasons discussed above, and because of Impax's request, FDA is
withdrawing approval of ANDA 077895, and all amendments and supplements
thereto, under Sec. 314.150(d). Distribution of Ursodiol Capsules USP,
300 mg, in interstate commerce without an approved application is
illegal and subject to regulatory action (see sections 505(a) and
301(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(a)
and 331(d)).
Dated: September 6, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-19908 Filed 9-13-19; 8:45 am]
BILLING CODE 4164-01-P