[Federal Register Volume 83, Number 163 (Wednesday, August 22, 2018)]
[Notices]
[Pages 42512-42513]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-18045]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2018-P-1335 and FDA-2018-P-1361]


Determination That DITROPAN XL (Oxybutynin Chloride) Extended 
Release Tablets, 15 Milligrams, Were Not Withdrawn From Sale for 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 DITROPAN XL (oxybutynin chloride) Extended Release 
Tablets, 15 milligrams (mg), were not withdrawn from sale for reasons 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 DITROPAN XL 
(oxybutynin chloride) Extended Release Tablets, 15 mg, if all other 
legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Glen Cheng, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, Rm. 6210, Silver Spring, MD 20993-0002, 301-796-1494.

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.
    DITROPAN XL (oxybutynin chloride) Extended Release Tablets, 5 mg, 
10 mg, and 15 mg, are the subject of NDA 020897, held by Janssen 
Pharmaceuticals Inc., and initially approved on December 16, 1998. 
DITROPAN XL is indicated for the treatment of overactive bladder with 
symptoms of urge urinary incontinence, urgency, and frequency, and for 
the treatment of pediatric patients aged 6 years and older with 
symptoms of detrusor overactivity associated with a neurological 
condition (e.g., spina bifida).
    In a letter dated December 14, 2017, Janssen Pharmaceuticals Inc. 
notified FDA that DITROPAN XL (oxybutynin chloride) Extended Release 
Tablets, 15 mg, were being discontinued, and FDA moved the drug product 
to the ``Discontinued Drug Product List'' section of the Orange Book. 
Although DITROPAN XL (oxybutynin chloride) Extended Release Tablets, 5 
mg and 10 mg, were also previously listed in the ``Discontinued Drug 
Product List'' section of the Orange Book, they are now listed in the 
``Prescription Drug Product List'' section of the Orange Book.
    Hyman, Phelps & McNamara, P.C., submitted a citizen petition dated 
March 30, 2018 (Docket No. FDA-2018-P-1335), and Ajanta Pharma Limited 
submitted a citizen petition dated April 2, 2018 (Docket No. FDA-2018-
P-1361), under 21 CFR 10.30, requesting that the Agency determine 
whether DITROPAN XL (oxybutynin chloride) Extended Release Tablets, 5 
mg, 10 mg, and 15 mg, were withdrawn from sale for reasons of safety or 
effectiveness.
    As noted, DITROPAN XL (oxybutynin chloride) Extended Release 
Tablets, 5 mg and 10 mg, are no longer listed in the ``Discontinued 
Drug Product List'' section of the Orange Book, and therefore we need 
not determine whether they were withdrawn from sale for reasons of 
safety or effectiveness.
    With regard to DITROPAN XL (oxybutynin chloride) Extended Release 
Tablets, 15 mg, 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 DITROPAN XL (oxybutynin 
chloride) Extended Release Tablets, 15 mg, were not withdrawn from sale 
for reasons of safety or effectiveness. The petitioners have identified 
no data or other information suggesting that this drug

[[Page 42513]]

product was withdrawn for reasons of safety or effectiveness. We have 
carefully reviewed our files for records concerning the withdrawal of 
DITROPAN XL (oxybutynin chloride) Extended Release Tablets, 15 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 DITROPAN XL 
(oxybutynin chloride) Extended Release Tablets, 15 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 DITROPAN XL 
(oxybutynin chloride) Extended Release Tablets, 15 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: August 15, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-18045 Filed 8-21-18; 8:45 am]
 BILLING CODE 4164-01-P