[Federal Register Volume 85, Number 149 (Monday, August 3, 2020)]
[Notices]
[Pages 46657-46658]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-16784]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-3723]
Watson Laboratories, Inc.; Withdrawal of Approval of an
Abbreviated New Drug Application for Oxycodone Hydrochloride and
Ibuprofen Tablets
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration's (FDA) Center for Drug
Evaluation and Research (CDER) is withdrawing approval of an
abbreviated new drug application (ANDA) for oxycodone hydrochloride and
ibuprofen tablets. The basis for the withdrawal is that the holder of
the ANDA has repeatedly failed to submit the required data to support a
finding of bioequivalence for this ANDA. The holder of the ANDA has
waived its opportunity for a hearing.
DATES: Approval is withdrawn as of August 3, 2020.
FOR FURTHER INFORMATION CONTACT: Jennifer Forde, 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: FDA's Office of Generic Drugs (OGD) approved
ANDA 078394, held by Watson Laboratories, Inc. (Watson),\1\ for a
generic version of oxycodone hydrochloride and ibuprofen tablets, 5
milligrams (mg)/400 mg, under the requirements of section 505(j) of the
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) and
FDA's implementing regulations. The OGD approved ANDA 078394 on
November 26, 2007. In a notice of opportunity for a hearing (NOOH)
published in the Federal Register of October 28, 2019 (84 FR 57739),
CDER notified Watson of CDER's proposal to issue an order, under
section 505(e) of the FD&C Act and Sec. 314.150 (21 CFR 314.150),
withdrawing approval of ANDA 078394 and all amendments and supplements
to it on the grounds that Watson has failed to submit the required
bioequivalence data necessary to demonstrate the bioequivalence of its
drug product.
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\1\ In correspondence dated February 23, 2017, Watson notified
FDA that Watson is an indirect, wholly-owned subsidiary of Teva
Pharmaceuticals USA, Inc.
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As noted in the October 28, 2019, NOOH, FDA issued a letter to
Watson on August 9, 2011, regarding ANDA 078394 because this drug
product application was supported by bioequivalence studies with the
bioanalytical analysis conducted by Cetero Research at the Houston, TX,
site between April 1, 2005, and June 15, 2010. As FDA noted in its
August 9, 2011 correspondence, inspection findings regarding Cetero
Research's bioequivalence studies raised significant concerns about the
validity of the reported results of the analytical studies conducted
between April 2005 and June 2010 in support of drug applications.
Accordingly, FDA informed Watson that ANDA 078394 needed to be
supplemented by conducting new bioequivalence studies or re-assaying
[[Page 46658]]
the samples from the original bioequivalence study. FDA recommended to
Watson that the results of the requested bioequivalence studies or re-
assays be submitted to ANDA 078394 within 6 months of the date of the
August 9, 2011, letter.
In its October 28, 2019, notice of opportunity for a hearing, CDER
provided Watson with an opportunity to request a hearing to show why
approval of ANDA 078394 should not be withdrawn. No request for a
hearing on this matter was received following publication of the notice
for an opportunity for a hearing in the Federal Register. Failure to
file a written notice of participation and request for a hearing as
required by Sec. 314.200 (21 CFR 314.200) constitutes an election by
Watson not to make use of the opportunity for a hearing concerning the
proposal to withdraw approval of ANDA 078394 and a waiver of any
contentions concerning the legal status of the drug product. We note
that in correspondence dated November 1, 2019, Watson requested
withdrawal of the approval of ANDA 078394 under Sec. 314.150(c) (21
CFR 314.150(c)). Because this application withdrawal is effectuated
through the notice-of-opportunity-for-a-hearing process (see 84 FR
57739), Watson's request to withdraw approval under Sec. 314.150(c) is
moot.
FDA finds that Watson has repeatedly failed to submit the required
data to support a finding of bioequivalence for ANDA 078394. In
addition, under Sec. 314.200, FDA finds that Watson has waived any
contentions concerning the legal status of the drug product. Therefore,
under section 505(e) of the FD&C Act, approval of ANDA 078394, and all
amendments and supplements thereto, is withdrawn (see DATES).
Introduction or delivery for introduction of this drug product into
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), 331(d))).
Dated: July 28, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-16784 Filed 7-31-20; 8:45 am]
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