[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hearing to show why approval of ANDA 078320 should not be withdrawn.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,

[[Page 41999]]

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]
BILLING CODE 4164-01-P