[Federal Register Volume 77, Number 97 (Friday, May 18, 2012)]
[Notices]
[Page 29665]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-12040]



[[Page 29665]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-P-0604]


Determination That PITRESSIN TANNATE IN OIL (Vasopressin Tannate) 
Injection, 5 Pressor Units/Milliliter, Was Not Withdrawn From Sale for 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) has determined that 
PITRESSIN TANNATE IN OIL (vasopressin tannate) Injection, 5 pressor 
units/milliliter (mL), was not withdrawn from sale for reasons of 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 vasopressin tannate 
injection, 5 pressor units/mL, if all other legal and regulatory 
requirements are met.

FOR FURTHER INFORMATION CONTACT: Molly Flannery, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 6246, Silver Spring, MD 20993-0002, 301-
796-3543.

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 (21 CFR 314.161). FDA may not approve an ANDA that does not refer 
to a listed drug.
    PITRESSIN TANNATE IN OIL (vasopressin tannate) Injection, 5 pressor 
units/mL, is the subject of NDA 03-402, held by Parke-Davis 
Pharmaceutical Research (Parke-Davis). PITRESSIN TANNATE IN OIL is 
indicated for the control or prevention of the symptoms and 
complications of diabetes insipidus due to a deficiency of endogenous 
posterior pituitary antidiuretic hormone.
    In a letter dated April 23, 1993, Parke-Davis requested the 
withdrawal of NDA 03-402 for PITRESSIN TANNATE IN OIL (vasopressin 
tannate) Injection, 5 pressor units/mL. In the Federal Register of 
September 25, 1998 (63 FR 51359), FDA announced that it was withdrawing 
approval of NDA 03-402, effective September 25, 1998.
    Lachman Consultant Services, Inc., submitted a citizen petition 
dated November 19, 2010 (Docket No. FDA-2010-P-0604), under 21 CFR 
10.30, requesting that the Agency determine whether PITRESSIN TANNATE 
IN OIL (vasopressin tannate) Injection, 5 pressor units/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 PITRESSIN TANNATE IN OIL (vasopressin tannate) 
Injection, 5 pressor units/mL, was not withdrawn for reasons of safety 
or effectiveness. The petitioner has identified no data or other 
information suggesting that PITRESSIN TANNATE IN OIL (vasopressin 
tannate) Injection, 5 pressor units/mL, was withdrawn for reasons of 
safety or effectiveness. We have carefully reviewed our files for 
records concerning the withdrawal of PITRESSIN TANNATE IN OIL 
(vasopressin tannate) Injection, 5 pressor units/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 this product was withdrawn from sale for reasons of 
safety or effectiveness.
    Accordingly, the Agency will continue to list PITRESSIN TANNATE IN 
OIL (vasopressin tannate) Injection, 5 pressor units/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 PITRESSIN TANNATE IN 
OIL (vasopressin tannate) Injection, 5 pressor units/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: May 14, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-12040 Filed 5-17-12; 8:45 am]
BILLING CODE 4160-01-P