[Federal Register Volume 85, Number 134 (Monday, July 13, 2020)]
[Notices]
[Pages 41998-41999]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-14981]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-3708]
InvaGen Pharmaceuticals, Inc.; Withdrawal of Approval of an
Abbreviated New Drug Application for Trandolapril Tablets
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration's (FDA or Agency) Center for
Drug Evaluation and Research (CDER) is withdrawing approval of an
abbreviated new drug application (ANDA) for trandolapril 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: Withdrawal of approval is applicable July 13, 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 078320, held by InvaGen Pharmaceuticals, Inc. (InvaGen), for a
generic version of trandolapril tablets, 1 milligram (mg), 2 mg, and 4
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. OGD approved ANDA 078320 on June 12, 2007. In a notice
published in the Federal Register of October 28, 2019 (84 FR 57736),
CDER notified InvaGen 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 078320 and all amendments and supplements
to it on the grounds that InvaGen has failed to submit the required
bioequivalence data necessary to demonstrate the bioequivalence of its
drug product. In its October 28, 2019, notice of opportunity for a
hearing (NOOH), CDER provided InvaGen with an opportunity to request a
hearing to show why approval of ANDA 078320 should not be withdrawn.
As noted in the October 28, 2019, NOOH, FDA issued a letter to
InvaGen on August 9, 2011, regarding ANDA 078320 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, and
as such, steps needed to be taken to demonstrate the bioequivalence of
InvaGen's drug product approved under ANDA 078320. FDA informed InvaGen
that ANDA 078320 needed to be supplemented by conducting new
bioequivalence studies or re-assaying the samples from the original
bioequivalence study. FDA recommended to InvaGen that the results of
the requested bioequivalence studies or re-assays be submitted to ANDA
078320 within 6 months of the date of the August 9, 2011, letter.
Although the October 28, 2019, NOOH states that FDA did not receive
a response from InvaGen to the August 9, 2011, letter from FDA, upon
further review, additional correspondence between InvaGen and FDA has
been identified. In a letter to FDA dated August 12, 2011, InvaGen
requested a 6-month extension for submitting bioequivalence study data
for ANDA 078320. On September 21, 2011, FDA issued a letter to InvaGen
acknowledging InvaGen's August 12, 2011, request for an extension. In a
letter to FDA dated September 6, 2012, InvaGen requested an additional
6-month extension to submit bioequivalence study data; and in a letter
to FDA dated October 4, 2012,
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InvaGen requested that FDA consider and grant InvaGen's request for an
extension. On October 23, 2012, FDA issued a letter to InvaGen granting
InvaGen an extension until March 2013 to submit bioequivalence study
data. InvaGen has not submitted the bioequivalence study data.
The additional correspondence noted above that was not identified
in the October 28, 2019, NOOH does not alter the underlying basis of
the October 28, 2019, NOOH. In the absence of information showing
bioequivalence between the generic drug at issue and the reference
listed drug (RLD), there is no basis for concluding that the Agency's
finding of safety and efficacy supporting approval of the RLD can be
used as a basis to support approval of the generic drug. Section 505(e)
of the FD&C Act provides FDA the authority to withdraw approval of an
ANDA in these circumstances.
In correspondence dated November 7, 2019, InvaGen requested
withdrawal of the approval of ANDA 078320 under Sec. 314.150(d).
Because this application withdrawal is effectuated through the NOOH
process (see 84 FR 57736), InvaGen's request to withdraw approval under
Sec. 314.150(d) is moot. In the November 7, 2019, correspondence,
InvaGen also waived its opportunity for a hearing under Sec.
314.150(a).
FDA finds that InvaGen has repeatedly failed to submit the required
data to support a finding of bioequivalence for ANDA 078320. In
addition, under 21 CFR 314.200, FDA finds that InvaGen 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 078320, 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 7, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-14981 Filed 7-10-20; 8:45 am]
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