[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DATES: Approval is withdrawn as of September 16, 2019.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