[Federal Register Volume 76, Number 251 (Friday, December 30, 2011)]
[Notices]
[Pages 82302-82303]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-33549]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-P-0555]


Determination That HYCODAN (Hydrocodone Bitartrate and 
Homatropine Methylbromide) Tablets, 5 Milligrams/1.5 Milligrams, and 
HYCODAN (Hydrocodone Bitartrate and Homatropine Methylbromide) Oral 
Solution, 5 Milligrams/5 Milliliters and 1.5 Milligrams/5 Milliliters, 
Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness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) has determined that 
HYCODAN (hydrocodone bitartrate and homatropine methylbromide) tablets, 
5 milligrams (mg)/1.5 mg, and HYCODAN (hydrocodone bitartrate and 
homatropine methylbromide) oral solution, 5 mg/5 milliliters (mL) and 
1.5 mg/5 mL, were not withdrawn from sale for reasons of safety or 
effectiveness. This determination will allow FDA to approve abbreviated 
new drug applications (ANDAs) for hydrocodone bitartrate and 
homatropine methylbromide tablets, 5 mg/1.5 mg, and HYCODAN 
(hydrocodone bitartrate and homatropine methylbromide) oral solution, 5 
mg/5 mL and 1.5 mg/5 mL, if all other legal and regulatory requirements 
are met.

[[Page 82303]]


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 only clinical data 
required in an ANDA are data to show that the drug that is the subject 
of the ANDA is bioequivalent to the listed drug.
    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.
    HYCODAN (hydrocodone bitartrate and homatropine methylbromide) 
tablets, 5 mg/1.5 mg, and HYCODAN (hydrocodone bitartrate and 
homatropine methylbromide) oral solution, 5 mg/5 mL and 1.5 mg/5 mL, 
are the subject of NDA 05-213, held by Endo Pharmaceuticals, and 
initially approved on March 23, 1943. In 1982, a Drug Efficacy Study 
Implementation review concluded that HYCODAN syrup, tablets, and powder 
were effective ``for the symptomatic relief of cough.'' (47 FR 23809, 
June 1, 1982). Subsequently, the sponsor submitted an NDA for HYCODAN 
(hydrocodone bitartrate and homatropine methylbromide) tablets, 5 mg/
1.5 mg, and HYCODAN (hydrocodone bitartrate and homatropine 
methylbromide) oral solution, 5 mg/5 mL and 1.5 mg/5 mL, which was 
approved on July 26, 1988. HYCODAN is indicated for the symptomatic 
relief of cough in adults and children 6 years of age and older.
    In a letter dated January 4, 2008, Endo Pharmaceuticals notified 
FDA that HYCODAN (hydrocodone bitartrate and homatropine methylbromide) 
tablets, 5 mg/1.5 mg, were being discontinued, and FDA moved the drug 
product to the ``Discontinued Drug Product List'' section of the Orange 
Book. Vintage Pharmaceutical, Inc., submitted a citizen petition dated 
October 15, 2008 (Docket No. FDA-2008-P-0555), under 21 CFR 10.30, 
requesting that the Agency determine whether HYCODAN (hydrocodone 
bitartrate and homatropine methylbromide) tablets, 5 mg/1.5 mg, were 
withdrawn from sale for reasons of safety or effectiveness. Although 
the citizen petition did not request it, FDA has determined, on its own 
initiative, whether the oral solution dosage form was withdrawn for 
safety or effectiveness reasons.
    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 HYCODAN (hydrocodone bitartrate and 
homatropine methylbromide) tablets, 5 mg/1.5 mg, and HYCODAN 
(hydrocodone bitartrate and homatropine methylbromide) oral solution, 5 
mg/5 mL and 1.5 mg/5 mL, were not withdrawn for reasons of safety or 
effectiveness. The petitioner has identified no data or other 
information suggesting that HYCODAN (hydrocodone bitartrate and 
homatropine methylbromide) tablets, 5 mg/1.5 mg, or HYCODAN 
(hydrocodone bitartrate and homatropine methylbromide) oral solution, 5 
mg/5 mL and 1.5 mg/5 mL, were withdrawn for reasons of safety or 
effectiveness. We have carefully reviewed our files for records 
concerning the withdrawal of HYCODAN (hydrocodone bitartrate and 
homatropine methylbromide) tablets, 5 mg/1.5 mg, and HYCODAN 
(hydrocodone bitartrate and homatropine methylbromide) oral solution, 5 
mg/5 mL and 1.5 mg/5 mL, 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 
these products were withdrawn from sale for reasons of safety or 
effectiveness.
    Accordingly, the Agency will continue to list HYCODAN (hydrocodone 
bitartrate and homatropine methylbromide) tablets, 5 mg/1.5 mg, and 
HYCODAN (hydrocodone bitartrate and homatropine methylbromide) oral 
solution, 5 mg/5 mL and 1.5 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. ANDAs that refer to HYCODAN (hydrocodone bitartrate and 
homatropine methylbromide) tablets, 5 mg/1.5 mg, or HYCODAN 
(hydrocodone bitartrate and homatropine methylbromide) oral solution, 5 
mg/5 mL and 1.5 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: December 22, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-33549 Filed 12-29-11; 8:45 am]
BILLING CODE 4160-01-P