82 FR 5580 - Determination That SYMMETREL (Amantadine Hydrochloride), Syrup, 50 Milligrams/5 Milliliters, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 11 (January 18, 2017)

The Food and Drug Administration (FDA or Agency) has determined that SYMMETREL (amantadine hydrochloride), Syrup, 50 milligrams/5 milliliters (50 mg/5 mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to SYMMETREL, and it will allow FDA to continue to approve ANDAs that reference SYMMETREL if all other legal and regulatory requirements are met.

[Federal Register Volume 82, Number 11 (Wednesday, January 18, 2017)]
[Notices]
[Pages 5580-5581]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-01064]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-P-2469]


Determination That SYMMETREL (Amantadine Hydrochloride), Syrup, 
50 Milligrams/5 Milliliters, Was Not Withdrawn From Sale for Reasons of 
Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) has 
determined that SYMMETREL (amantadine hydrochloride), Syrup, 50 
milligrams/5 milliliters (50 mg/5 mL), was not withdrawn from sale for 
reasons of safety or effectiveness. This determination means that FDA 
will not begin procedures to withdraw approval of abbreviated new drug 
applications (ANDAs) that refer to SYMMETREL, and it will allow FDA to 
continue to approve ANDAs that reference SYMMETREL if all other legal 
and regulatory requirements are met.

[[Page 5581]]


FOR FURTHER INFORMATION CONTACT: Stefanie S. Kraus, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6215, Silver Spring, MD 20993-0002, 301-
796-9585.

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) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), 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. This determination 
may be made at any time after the drug has been withdrawn from sale, 
but must be made prior to approving an ANDA that refers to the listed 
drug (Sec.  314.161 (21 CFR 314.161)). FDA may not approve an ANDA that 
does not refer to a listed drug.
    SYMMETREL (amantadine hydrochloride), Syrup, 50 mg/5 mL, is the 
subject of NDAs 016023 and 017118, held by Endo Pharmaceuticals, and 
initially approved on February 14, 1968, and July 20, 1976, 
respectively. SYMMETREL is indicated for the prophylaxis and treatment 
of signs and symptoms of infection caused by various strains of 
influenza A virus. SYMMETREL is also indicated for the treatment of 
parkinsonism and drug-induced extrapyramidal reactions.
    In a letter dated March 19, 2009, Endo Pharmaceuticals notified FDA 
that SYMMETREL (amantadine hydrochloride), Syrup, 50 mg/5 mL, was being 
discontinued and requested withdrawal of NDA016023 for that product. 
FDA moved the drug product to the ``Discontinued Drug Product List'' 
section of the Orange Book and announced in the Federal Register of 
July 21, 2010 (75 FR 42455), that FDA was withdrawing approval of NDA 
016023, effective August 20, 2010.
    Hyman, Phelps & McNamara submitted a citizen petition dated August 
3, 2016 (Docket No. FDA-2016-P-2469), under 21 CFR 10.30, requesting 
that the Agency determine whether SYMMETREL (amantadine hydrochloride), 
Syrup, 50 mg/5 mL, was withdrawn from sale for reasons of safety or 
effectiveness.
    After considering the citizen petition and reviewing Agency records 
and based on the information we have at this time, FDA has determined 
under Sec.  314.161 that SYMMETREL (amantadine hydrochloride), Syrup, 
50 mg/5 mL, was not withdrawn for reasons of safety or effectiveness. 
The petitioner has identified no data or other information suggesting 
that this drug product was withdrawn for reasons of safety or 
effectiveness. We have carefully reviewed our files for records 
concerning the withdrawal of SYMMETREL (amantadine hydrochloride), 
Syrup, 50 mg/5 mL, from sale. We have also independently evaluated 
relevant literature and data for possible postmarketing adverse events. 
We have reviewed the available evidence and determined that this drug 
product was not withdrawn from sale for reasons of safety or 
effectiveness.\1\
---------------------------------------------------------------------------

    \1\ Due to high levels of resistance to currently circulating 
Influenza A viruses, the Centers for Disease Control and Prevention 
currently recommends against using amantadine to treat Influenza A. 
Given the potential for viral reassortment, however, amantadine may 
be effective against future Influenza A viruses. Consistent with 
this, the current label for SYMMETREL (amantadine hydrochloride), 
Syrup, 50 mg/5 mL, was revised to caution prescribers to consider 
susceptibility and clinical benefit when deciding whether to use 
amantadine to treat Influenza A.
---------------------------------------------------------------------------

    Accordingly, the Agency will continue to list SYMMETREL (amantadine 
hydrochloride), Syrup, 50 mg/5 mL, in the ``Discontinued Drug Product 
List'' section of the Orange Book. The ``Discontinued Drug Product 
List'' delineates, among other items, drug products that have been 
discontinued from marketing for reasons other than safety or 
effectiveness. FDA will not begin procedures to withdraw approval of 
approved ANDAs that refer to SYMMETREL. Additional ANDAs that refer to 
SYMMETREL (amantadine hydrochloride), Syrup, 50 mg/5 mL, 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: January 12, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-01064 Filed 1-17-17; 8:45 am]
 BILLING CODE 4164-01-P