[Federal Register Volume 82, Number 203 (Monday, October 23, 2017)]
[Notices]
[Pages 49032-49033]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-22892]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-P-3581]


Determination That ELAVIL (Amitriptyline Hydrochloride) Oral 
Tablets, 10, 25, 50, 75, 100, and 150 Milligrams, Were Not Withdrawn 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 ELAVIL (amitriptyline hydrochloride) oral tablets, 10 
milligrams (mg), 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg, were not 
withdrawn from sale for reasons of safety or effectiveness. This 
determination will allow FDA to approve abbreviated new drug 
applications (ANDAs) for amitriptyline hydrochloride oral tablets, 10 
mg, 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg, if all other legal and 
regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Stacy Kane, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002, 301-796-8363, 
[email protected].

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

[[Page 49033]]

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.
    ELAVIL (amitriptyline hydrochloride) oral tablets, 10 mg, 25 mg, 50 
mg, 75 mg, 100 mg, and 150 mg, are the subject of NDA 012703, held by 
AstraZeneca, and initially approved on April 7, 1961. ELAVIL is 
indicated for the relief of symptoms of depression. ELAVIL 
(amitriptyline hydrochloride) oral tablets, 10 mg, 25 mg, 50 mg, 75 mg, 
100 mg, and 150 mg, are currently listed in the ``Discontinued Drug 
Product List'' section of the Orange Book. In the Federal Register of 
June 16, 2006 (71 FR 34940), FDA announced that it was withdrawing 
approval of NDA 012703, effective June 16, 2006.
    Alembic Pharmaceuticals Limited submitted a citizen petition dated 
June 5, 2017 (Docket No. FDA-2017-P-3581), under 21 CFR 10.30, 
requesting that the Agency determine whether ELAVIL (amitriptyline 
hydrochloride) oral tablets, 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, and 
150 mg, were 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 ELAVIL (amitriptyline hydrochloride) oral 
tablets, 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg, were not 
withdrawn for reasons of safety or effectiveness. The petitioner has 
identified no data or other information suggesting that these products 
were withdrawn for reasons of safety or effectiveness. We have 
carefully reviewed our files for records concerning the withdrawal of 
ELAVIL (amitriptyline hydrochloride) oral tablets, 10 mg, 25 mg, 50 mg, 
75 mg, 100 mg, and 150 mg, from sale. We have also independently 
evaluated relevant literature and data for possible postmarketing 
adverse events. We have found no information that would indicate that 
this drug product was withdrawn from sale for reasons of safety or 
effectiveness.
    Accordingly, the Agency will continue to list ELAVIL (amitriptyline 
hydrochloride) oral tablets, 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, and 
150 mg, 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. ANDAs that refer to ELAVIL 
(amitriptyline hydrochloride) oral tablets, 10 mg, 25 mg, 50 mg, 75 mg, 
100 mg, and 150 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 17, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-22892 Filed 10-20-17; 8:45 am]
 BILLING CODE 4164-01-P


