Document ID: FDA-1977-N-0015-0012
Agency: fda
Document Type: Notice
Title: Drugs for Human Use; Drug Efficacy Study Implementation; Potassium Aminobenzoate Oral Preparations; Withdrawal of Hearing Request; Withdrawal of New Drug Application; Final Resolution of Drug Efficacy Study Implementation
Posted Date: 2022-03-09T05:00Z

[Federal Register Volume 87, Number 46 (Wednesday, March 9, 2022)]
[Notices]
[Pages 13294-13295]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-04971]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-1977-N-0015 (Formerly 77N-0187); DESI 7663]

Drugs for Human Use; Drug Efficacy Study Implementation; 
Potassium Aminobenzoate Oral Preparations; Withdrawal of Hearing 
Request; Withdrawal of New Drug Application; Final Resolution of Drug 
Efficacy Study Implementation

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
that all outstanding hearing requests regarding POTABA (potassium 
aminobenzoate) Tablets, Capsules, Powder, and Envules under Docket No. 
FDA-1977-N-0015 (formerly 77N-0187) (this Drug Efficacy Study 
Implementation (DESI) 7663) have been withdrawn. Therefore, as proposed 
in the notice of opportunity for hearing (NOOH), FDA finds that the 
products subject to the application identified in this docket, or any 
identical, related, or similar (IRS) products, have not been shown to 
be effective for use under the conditions of use prescribed, 
recommended, or suggested in the labeling, and hereby withdraws 
approval of the application under the Federal Food, Drug, and Cosmetic 
Act (FD&C Act).

DATES: This notice is applicable April 8, 2022.

ADDRESSES: For access to the docket to read background documents or the 
electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500 between 9 a.m. and 4 p.m., 
Monday through Friday. Publicly available submissions may be seen in 
the docket.
    The most relevant background documents regarding this matter are 
available in the docket. However, additional background documents are 
available upon request (see FOR FURTHER INFORMATION CONTACT).

FOR FURTHER INFORMATION CONTACT: Astrid Lopez-Goldberg, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 5185, Silver Spring, MD 20993-0002, 301-
796-3485, email: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In 1962, Congress amended the FD&C Act to require that new drugs be 
proven effective for their labeled indications, as well as safe, in 
order to obtain FDA approval (Drug Amendments of 1962 (Pub. L. 87-
781)). These amendments also required FDA to conduct a retrospective 
evaluation of the effectiveness of the drug products that FDA had 
approved as safe between 1938 and 1962. FDA contracted with the 
National Academy of Sciences/National Research Council (NAS/NRC) to 
make an initial evaluation of the effectiveness of over 3,400 products 
that had been approved only for safety between 1938 and 1962. The NAS/
NRC reports for these drug products were submitted to FDA in the late 
1960s and early 1970s. The Agency reviewed and reevaluated the reports 
and published its findings in Federal Register notices. FDA's 
administrative implementation of the NAS/NRC reports was called the 
DESI. DESI covered the approximately 3,400 products specifically 
reviewed by the NAS/NRC, as well as the even larger number of IRS 
products that entered the market without FDA approval. If FDA's final 
DESI determination classifies a drug product as lacking substantial 
evidence of effectiveness for one or more indications, that drug 
product and those IRS to it may no longer be marketed for such 
indications and are subject to enforcement action as unapproved new 
drugs.

II. Final Resolution of Hearing Request Regarding Potassium 
Aminobenzoate Oral Preparations Under Docket No. FDA-1977-N-0015 
(Formerly 77N-0187); DESI 7663

    In a Federal Register notice published on August 28, 1970 (35 FR 
13755), FDA announced its evaluation of a report received from the NAS/
NRC under DESI 7663 regarding POTABA (potassium aminobenzoate) Tablets, 
Capsules, Powder, and Envules, New Drug Application (NDA) 007663, held 
by Glenwood LLC (formerly known as Glenwood Laboratories, Inc.), 83 
Summit St., Tenafly, NJ 07670 (herein after ``Glenwood''). The notice 
stated that the drug products were possibly effective in the treatment 
of scleroderma, dermatomyositis, morphea, linear scleroderma, 
pemphigus, and Peyronie's Disease and lacked substantial evidence of 
effectiveness for the treatment of rheumatoid arthritis, sarcoidosis, 
and pulmonary fibrosis. Glenwood, and any other person marketing such 
drug products without approval, was given 60 days to revise its 
labeling to delete those indications for which substantial evidence of 
effectiveness was lacking and 6 months to submit data to provide 
substantial evidence of effectiveness for the indications for which the 
drug was regarded as possibly effective. The notice stated that, at the 
end of the 6-month period, FDA would evaluate the data to determine 
whether substantial evidence of effectiveness had been provided, and, 
if it had not, FDA would initiate the withdrawal of approval of NDA 
007663 under section 505(e) of the FD&C Act (21 U.S.C. 355(e)).
    Glenwood did not submit data to provide substantial evidence of 
effectiveness for the indications for which the drug was regarded as 
possibly effective within the period provided by the 1970 Federal 
Register notice, and the Agency issued a NOOH on the proposed 
withdrawal of approval of NDA 007663 in the Federal Register of 
February 4, 1972 (37 FR 2688).
    In response to a court order, FDA published a notice in the Federal 
Register on December 14, 1972 (37 FR 26623), which stated that POTABA, 
among other drugs, could remain on the market pending completion of 
further scientific studies.
    In a Federal Register notice published on August 19, 1977 (42 FR 
41922), the Agency revoked the exemption granted in the December 14, 
1972, notice pursuant to which POTABA had remained on the market 
pending its continued study. In a separate NOOH for DESI 7663, also 
published in the Federal Register of August 19, 1977 (42 FR 41921), FDA 
noted that Glenwood did not submit data providing substantial evidence 
of effectiveness and that no other person had submitted data or 
protocols or expressed an intention to perform clinical studies on 
potassium aminobenzoate. This notice reclassified the possibly 
effective indications to lacking substantial evidence of effectiveness 
and proposed to issue an order under section 505(e) of the FD&C Act 
withdrawing approval of Glenwood's NDA and all amendments

[[Page 13295]]

and supplements thereto on the grounds that new information, evaluated 
together with the evidence available when the application was approved, 
showed there is a lack of substantial evidence that the drug is 
effective under the conditions of use prescribed, recommended, or 
suggested in the labeling. The Agency again invited Glenwood, and any 
other interested person(s) who would be adversely affected by the 
withdrawal of approval of NDA 007663, to submit: (1) On or before 
September 19, 1977, a written notice of appearance and request for 
hearing and (2) on or before October 17, 1977, the data, information, 
and analyses relied upon to justify a hearing.
    On September 12, 1977, Glenwood filed a written notice of 
appearance and requested a hearing, and on October 17, 1977, Glenwood 
submitted data in support of its hearing request. Along with these 
submissions, Glenwood requested that the Agency delay action on the 
hearing request until the firm had conducted another placebo-controlled 
study. Subsequently, Glenwood initiated a clinical trial at the 
Downstate Medical Center of the State University of New York and 
supplemented its hearing request with additional data, including a 
progress report on the clinical trial of POTABA conducted at the 
Downstate Medical Center.
    Following a meeting between Glenwood and FDA on November 18, 1985, 
Glenwood sponsored another controlled clinical trial, and the final 
study report was submitted on February 4, 1993.
    By letter dated October 21, 2010, FDA asked Glenwood whether it 
wanted to pursue its pending hearing request regarding POTABA. By 
letter dated November 11, 2010, Glenwood affirmed its hearing request.
    By letter dated June 8, 2020, FDA again asked Glenwood whether it 
wanted to pursue its pending hearing request regarding POTABA. By 
letter dated July 2, 2020, Cheplapharm Arzneimittel GmbH, successor-in-
interest to Glenwood LLC, stated that it did not wish to pursue the 
hearing request for POTABA.

III. Conclusions and Order

    There are no outstanding hearing requests regarding potassium 
aminobenzoate oral preparations under Docket No. FDA-1977-N-0015, DESI 
7663. Therefore, as proposed in the NOOH, FDA withdraws approval of NDA 
007663 under section 505(e) of the FD&C Act.
    Shipment in interstate commerce of any drug product identified in 
this docket under DESI 7663, or any IRS product, that is not the 
subject of an approved NDA or abbreviated new drug application is 
unlawful as of the effective date of this notice (see DATES). Any 
person who wishes to determine whether this notice covers a specific 
product should write to Astrid Lopez-Goldberg at the Center for Drug 
Evaluation and Research (see FOR FURTHER INFORMATION CONTACT). Firms 
should be aware that, after the applicable date of this notice (see 
DATES), FDA intends to take enforcement action without further notice 
against any firm that manufactures or ships in interstate commerce any 
unapproved product covered by this notice.

IV. Discontinued Products

    Firms must notify the Agency of certain product discontinuations in 
writing under section 506C(a) of the FD&C Act (21 U.S.C. 356c). See 
http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm142398.htm. Some 
firms may have previously discontinued manufacturing or distributing 
products covered by this notice without discontinuing the listing as 
required under section 510(j) of the FD&C Act (21 U.S.C. 360(j)). Other 
firms may discontinue manufacturing or distributing listed products in 
response to this notice. All firms are required to electronically 
update the listing of their products under 510(j) of the FD&C Act to 
reflect discontinuation of unapproved products covered by this notice 
(21 CFR 207.57(b)). Questions on electronic drug listing updates should 
be sent to [email protected]. In addition to the required update, firms 
can also notify the Agency of product discontinuation by sending a 
letter, signed by the firm's chief executive officer and fully 
identifying the discontinued product(s), including the product National 
Drug Code number(s), and stating that the manufacturing and/or 
distribution of the product(s) have been discontinued. The letter 
should be sent electronically to Astrid Lopez-Goldberg (see FOR FURTHER 
INFORMATION CONTACT). FDA plans to rely on its existing records, 
including its drug listing records, the results of any future 
inspections, or other available information, when it identifies 
violative products for enforcement action.

    Dated: March 3, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-04971 Filed 3-8-22; 8:45 am]
BILLING CODE 4164-01-P