[Federal Register Volume 62, Number 225 (Friday, November 21, 1997)]
[Notices]
[Page 62322]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-30614]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97N-0446]


Determination That Desmopressin Acetate Nasal Solution 0.01% (for 
Refrigerated Storage) Was Not Withdrawn From Sale for Reasons of Safety 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 desmopressin acetate (DDAVP Nasal Spray) nasal 
solution 0.01% (for refrigerated storage) was not withdrawn from sale 
for reasons of safety or effectiveness. This determination will allow 
FDA to approve abbreviated new drug applications (ANDA's) for 
desmopressin acetate nasal solution 0.01% (for refrigerated storage).

FOR FURTHER INFORMATION CONTACT: Mary E. Catchings, Center for Drug 
Evaluation and Research (HFD-7), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-2041.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price 
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) 
(the 1984 amendments) that authorized the approval of duplicate 
versions of drug products approved under an ANDA procedure. ANDA 
sponsors 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 under a new drug 
application (NDA). Sponsors of ANDA's do not have to repeat the 
extensive clinical testing otherwise necessary to gain approval of an 
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 included what is now section 505(j)(6) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(6)), 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 generally known as the ``Orange 
Book.'' Under FDA regulations, drugs are withdrawn from the list if the 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.
    In accordance with Sec. 314.161(a)(1) and (e), the agency initiated 
procedures to determine whether desmopressin acetate nasal solution 
0.01% (for refrigerated storage) was withdrawn from sale for reasons of 
safety or effectiveness. Desmopressin acetate (DDAVP Nasal Spray) nasal 
solution 0.01% is the subject of approved NDA 17-922 held by Rhone-
Poulenc Rorer Pharmaceuticals, Inc. The original formulation of 
desmopressin acetate nasal solution 0.01% (NDA 17-922) provided for 
refrigerated storage of the product. On August 7, 1996, FDA approved 
Rhone-Poulenc Rorer Pharmaceutical, Inc.'s supplemental application 
providing for reformulation of desmopressin acetate nasal solution 
0.01% for room temperature storage. Rhone-Poulenc Rorer Pharmaceutical, 
Inc., later withdrew the original formulation, citing easier storage 
and convenience with the reformulated product.
    FDA has reviewed its records and, under Sec. 314.161, has 
determined that desmopressin acetate nasal solution 0.01% (for 
refrigerated storage) was not withdrawn from sale for reasons of safety 
or effectiveness. Accordingly, the agency will maintain desmopressin 
acetate nasal solution 0.01% (for refrigerated storage) 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. ANDA's that refer to desmopressin acetate 
nasal solution 0.01% (for refrigerated storage) may be approved by the 
agency.

    Dated: November 14, 1997.
 William K. Hubbard,
 Associate Commissioner for Policy Coordination.
[FR Doc. 97-30614 Filed 11-20-97; 8:45 am]
BILLING CODE 4160-01-F