[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Refrigerated Storage) Was Not Withdrawn From Sale for Reasons of Safety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solution 0.01% (for refrigerated storage) was not withdrawn from sale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 Under FDA regulations, drugs are withdrawn from the list if the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
