[Federal Register Volume 73, Number 226 (Friday, November 21, 2008)]
[Notices]
[Pages 70653-70654]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-27714]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-P-0029]


Determination That NUBAIN (Nalbuphine Hydrochloride) Injection, 
10 and 20 Milligrams/Milliliter, Was Not Withdrawn From Sale for 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) is announcing its 
determination that NUBAIN (nalbuphine hydrochloride) injection, 10 and 
20 milligrams/milliliter (mg/ml), was not withdrawn from sale for 
reasons of safety or effectiveness. This determination will allow FDA 
to approve abbreviated new drug applications (ANDAs) for nalbuphine 
hydrochloride injection, 10 and 20 mg/ml, if all other legal and 
regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Carol E. Drew, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 6306, 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 approved 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

[[Page 70654]]

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). Regulations also provide that the 
agency must make a determination as to whether a listed drug was 
withdrawn from sale for reasons of safety or effectiveness before an 
ANDA that refers to that listed drug may be approved (Sec.  
314.161(a)(1) (21 CFR 314.161(a)(1))). FDA may not approve an ANDA that 
does not refer to a listed drug.
    On January 11, 2008, West-Ward Pharmaceutical Corp., on behalf of 
Hikma Farmac[ecirc]utica of Portugal, submitted a citizen petition 
(Docket No. FDA-2008-P-0029) to FDA under 21 CFR 10.30. The petition 
requests that the agency determine whether NUBAIN (nalbuphine 
hydrochloride) injection, 10 and 20 mg/ml (NDA 18-024), manufactured by 
Endo Pharmaceuticals (Endo), was withdrawn from sale for reasons of 
safety or effectiveness. NUBAIN was approved on May 15, 1979. NUBAIN is 
an analgesic drug product used for the relief of moderate to severe 
pain. NUBAIN may be used as a supplement to balanced anesthesia, for 
preoperative and postoperative analgesia, and for obstetrical analgesia 
during labor and delivery. Manufacture of NUBAIN was discontinued in 
2003, and the drug product was moved from the prescription drug product 
list to the ``Discontinued Drug Product List'' section of the Orange 
Book.
    FDA has reviewed its records and, under Sec.  314.161, has 
determined that NUBAIN (nalbuphine hydrochloride) injection, 10 and 20 
mg/ml, was not withdrawn from sale for reasons of safety or 
effectiveness. The petitioner identified no data or other information 
suggesting that NUBAIN (nalbuphine hydrochloride) injection, 10 and 20 
mg/ml, was withdrawn for reasons of safety or effectiveness. FDA has 
independently evaluated relevant literature and data for possible 
postmarketing adverse events and has found no information that would 
indicate that this product was withdrawn from sale for reasons of 
safety or effectiveness. Accordingly, the agency will continue to list 
NUBAIN (nalbuphine hydrochloride) injection, 10 and 20 mg/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 NUBAIN (nalbuphine 
hydrochloride) injection, 10 and 20 mg/ml, may be approved by the 
agency if all other legal and regulatory requirementsfor the approval 
of ANDAs are met. 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: November 14, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-27714 Filed 11-20-08; 8:45 am]
BILLING CODE 4160-01-S