[Federal Register Volume 84, Number 204 (Tuesday, October 22, 2019)]
[Notices]
[Pages 56459-56460]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-23014]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-4466]


Determination That PROAMATINE (Midodrine Hydrochloride) Tablets, 
2.5 Milligrams, 5 Milligrams, and 10 Milligrams, Were Not Withdrawn 
From Sale for Reasons of Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) has 
determined that PROAMATINE (midodrine hydrochloride) tablets, 2.5 
milligrams (mg), 5 mg, and 10 mg, were not withdrawn from sale for 
reasons of safety or effectiveness. This determination allows FDA to 
approve abbreviated new drug applications (ANDAs) for midodrine 
hydrochloride tablets, 2.5 mg, 5 mg, and 10 mg, if all other legal and 
regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Kristiana Brugger, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6262, Silver Spring, MD 20993-0002, 301-
796-3601.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price 
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) 
(the 1984 amendments), which authorized the approval of duplicate 
versions of drug products under an ANDA procedure. ANDA applicants 
must, with certain exceptions, show that the drug for which they are 
seeking approval contains the same active ingredient in the same 
strength and dosage form as the ``listed drug,'' which is a version of 
the drug that was previously approved. ANDA applicants do not have to 
repeat the extensive clinical testing otherwise necessary to gain 
approval of a new drug application (NDA).
    The 1984 amendments include what is now section 505(j)(7)(A) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)(A)), which 
requires FDA to publish a list of all approved drugs. FDA publishes 
this list as part of the ``Approved Drug Products With Therapeutic 
Equivalence Evaluations,'' which is known generally as the ``Orange 
Book.'' Under FDA regulations, drugs are removed from the list if the 
Agency withdraws or suspends approval of the drug's NDA or ANDA for 
reasons of safety or effectiveness or if FDA determines that the listed 
drug was withdrawn from sale for reasons of safety or effectiveness (21 
CFR 314.162).
    A person may petition the Agency to determine, or the Agency may 
determine on its own initiative, whether a listed drug was withdrawn 
from sale for reasons of safety or effectiveness.
    PROAMATINE (midodrine hydrochloride) tablets, 2.5 mg, 5 mg, and 10 
mg, is the subject of NDA 019815, held by Shire Development LLC 
(Shire), and initially approved on September 6, 1996, under the 
accelerated approval process (see 21

[[Page 56460]]

CFR 314.510). PROAMATINE is indicated for the treatment of orthostatic 
hypotension. PROAMATINE (midodrine hydrochloride) tablets, 2.5 mg, 5 
mg, and 10 mg, is currently listed in the ``Discontinued Drug Product 
List'' section of the Orange Book. Shire no longer markets PROAMATINE 
in any strength; although there are approved ANDAs referencing NDA 
019815, PROAMATINE has been withdrawn from sale.
    We have carefully reviewed our files for records concerning the 
withdrawal of PROAMATINE (midodrine hydrochloride) tablets, 2.5 mg, 5 
mg, and 10 mg, from sale. We have also independently evaluated relevant 
literature and data for possible postmarketing adverse events. FDA has 
determined under Sec.  314.161 that PROAMATINE (midodrine 
hydrochloride) tablets, 2.5 mg, 5 mg, and 10 mg, were not withdrawn 
from sale for reasons of safety or effectiveness.
    Accordingly, FDA will continue to list PROAMATINE (midodrine 
hydrochloride) tablets, 2.5 mg, 5 mg, and 10 mg, in the ``Discontinued 
Drug Product List'' section of the Orange Book. We note that, because 
PROAMATINE (midodrine hydrochloride) tablets, 2.5 mg, 5 mg, and 10 mg, 
were approved under the accelerated approval pathway, Shire was 
required to conduct post-approval studies to verify the clinical 
benefit of PROAMATINE (midodrine hydrochloride) tablets, 2.5 mg, 5 mg, 
and 10 mg. The clinical benefit of PROAMATINE (midodrine hydrochloride) 
tablets, 2.5 mg, 5 mg, and 10 mg, remains subject to verification.
    ANDAs that refer to PROAMATINE (midodrine hydrochloride) tablets, 
2.5 mg, 5 mg, and 10 mg, may be approved by the Agency as long as they 
meet all other legal and regulatory requirements for the approval of 
ANDAs. If FDA determines that labeling for this drug product should be 
revised to meet current standards, the Agency will advise ANDA 
applicants to submit such labeling.

    Dated: October 15, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-23014 Filed 10-21-19; 8:45 am]
 BILLING CODE 4164-01-P