80 FR 29720 - Determination That VAGIFEM (Estradiol) Vaginal Tablets, 25 Micrograms, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 99 (May 22, 2015)

Page Range		29720-29721
FR Document		2015-12396

The Food and Drug Administration (FDA or Agency) has determined that VAGIFEM (estradiol) Vaginal Tablets, 25 micrograms, was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.

Federal Register, Volume 80 Issue 99 (Friday, May 22, 2015)

[Federal Register Volume 80, Number 99 (Friday, May 22, 2015)]
[Notices]
[Pages 29720-29721]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-12396]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-P-0482]


Determination That VAGIFEM (Estradiol) Vaginal Tablets, 25 
Micrograms, Was Not Withdrawn From Sale for Reasons of Safety or 
Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) has 
determined that VAGIFEM (estradiol) Vaginal Tablets, 25 micrograms, was 
not withdrawn from sale for reasons of safety or effectiveness. This 
determination means that FDA will not begin procedures to withdraw 
approval of abbreviated new drug applications (ANDAs) that refer to 
this drug product, and it will allow FDA to continue to approve ANDAs 
that refer to the product as long as they meet relevant legal and 
regulatory requirements.

FOR FURTHER INFORMATION CONTACT: Elaine Lippmann, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6214, Silver Spring, MD 20993-0002, 301-
796-3602, Elaine.Lippmann@fda.hhs.gov.

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 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 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 generally known as the ``Orange 
Book.'' Under FDA regulations, a drug is 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).
    Under Sec.  314.161(a) (21 CFR 314.161(a)), the Agency must 
determine whether a listed drug was withdrawn from sale for reasons of 
safety or effectiveness: (1) Before an ANDA that refers to that listed 
drug may be approved, (2) whenever a listed drug is voluntarily 
withdrawn from sale and ANDAs that refer to the listed drug have been 
approved, and (3) when a person petitions for such a determination 
under 21 CFR 10.25(a) and 10.30. Section 314.161(d) provides that if 
FDA determines that a listed drug was withdrawn from sale for safety or 
effectiveness reasons, the Agency will initiate proceedings that could 
result in the withdrawal of approval of the ANDAs that refer to the 
listed drug.

[[Page 29721]]

    FDA has become aware that the drug product listed in the table in 
this document is no longer being marketed.

------------------------------------------------------------------------
      Application No.                 Drug                Applicant
------------------------------------------------------------------------
NDA 020908.................  VAGIFEM (estradiol)    Novo Nordisk Inc.,
                              Vaginal Tablets, 25    800 Scudders Mill
                              micrograms.            Rd., Plainsboro, NJ
                                                     08536.
------------------------------------------------------------------------

    FDA has reviewed its records and, under Sec.  314.161, has 
determined that the drug product listed in this document was not 
withdrawn from sale for reasons of safety or effectiveness. 
Accordingly, the Agency will continue to list the drug product listed 
in this document in the ``Discontinued Drug Product List'' section of 
the Orange Book. The ``Discontinued Drug Product List'' identifies, 
among other items, drug products that have been discontinued from 
marketing for reasons other than safety or effectiveness.
    Approved ANDAs that refer to the NDA listed in this document are 
unaffected by the discontinued marketing of the product subject to this 
NDA. Additional ANDAs that refer to this product may also be approved 
by the Agency if they comply with relevant legal and regulatory 
requirements. If FDA determines that labeling for estradiol vaginal 
tablets should be revised to meet current standards, the Agency will 
advise ANDA applicants to submit such labeling.

    Dated: May 18, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-12396 Filed 5-21-15; 8:45 am]
BILLING CODE 4164-01-P

29720 Federal Register / Vol. 80, No. 99 / Friday, May 22, 2015 / Notices

343(r)(3)(A)) provides for the use of food Analytical methods for measuring total other than soy, and to make such
label statements characterizing a protein can be used to quantify the records available to appropriate
relationship of any nutrient of the type amount of soy protein in foods that regulatory officials upon written
required to be in the label or labeling of contain soy as the sole source of protein. request. The information collected
the food to a disease or a health related However, at the present time there is no includes nutrient databases or analyses,
condition only where that statement validated analytical methodology recipes or formulations, purchase orders
meets the requirements of the available to quantify the amount of soy for ingredients, or any other information
regulations promulgated by the protein in foods that contain other that reasonably substantiates the ratio of
Secretary of Health and Human Services sources of protein. For these latter soy protein to total protein.
to authorize the use of such a health foods, we must rely on information
In the Federal Register of March 10,
claim. Section 101.82 (21 CFR 101.82) of known only to the manufacturer to
our regulations authorizes a health assess compliance with the requirement 2015 (80 FR 12640), FDA published a
claim for food labels about soy protein that the food contain the qualifying 60-day notice requesting public
and the risk of coronary heart disease amount of soy protein. Thus, we require comment on the proposed collection of
(CHD). To bear the soy protein and CHD manufacturers to have and keep records information. No comments were
health claim, foods must contain at least to substantiate the amount of soy received.
6.25 grams of soy protein per reference protein in a food that bears the health We estimate the annual burden of this
amount customarily consumed. claim and contains sources of protein collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of re- Total annual
21 CFR section responses per burden per Total hours
spondents responses
respondent response

101.82(c)(2)(ii)(B) ................................................................. 25 1 25 1 25
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Based upon our experience with the SUMMARY: The Food and Drug necessary to gain approval of a new
use of health claims, we estimate that Administration (FDA or Agency) has drug application (NDA).
only about 25 firms would be likely to determined that VAGIFEM (estradiol) The 1984 amendments include what
market products bearing a soy protein/ Vaginal Tablets, 25 micrograms, was not is now section 505(j)(7) of the Federal
coronary heart disease health claim and withdrawn from sale for reasons of Food, Drug, and Cosmetic Act (21 U.S.C.
that only, perhaps, one of each firm’s safety or effectiveness. This
355(j)(7)), which requires FDA to
products might contain non-soy sources determination means that FDA will not
publish a list of all approved drugs.
of protein along with soy protein. The begin procedures to withdraw approval
records required to be retained by of abbreviated new drug applications FDA publishes this list as part of the
§ 101.82(c)(2)(ii)(B) are the records, e.g., (ANDAs) that refer to this drug product, ‘‘Approved Drug Products with
the formulation or recipe, that a and it will allow FDA to continue to Therapeutic Equivalence Evaluations,’’
manufacturer has and maintains as a approve ANDAs that refer to the which is generally known as the
normal course of its doing business. product as long as they meet relevant ‘‘Orange Book.’’ Under FDA regulations,
Thus, the burden to the food legal and regulatory requirements. a drug is removed from the list if the
manufacturer is limited to assembling Agency withdraws or suspends
FOR FURTHER INFORMATION CONTACT:
and retaining the records, which we approval of the drug’s NDA or ANDA
Elaine Lippmann, Center for Drug for reasons of safety or effectiveness or
estimate will take 1 hour annually.
Evaluation and Research, Food and
Dated: May 15, 2015. if FDA determines that the listed drug
Drug Administration, 10903 New
was withdrawn from sale for reasons of
Leslie Kux, Hampshire Ave., Bldg. 51, Rm. 6214,
safety or effectiveness (21 CFR 314.162).
Associate Commissioner for Policy. Silver Spring, MD 20993–0002, 301–
[FR Doc. 2015–12402 Filed 5–21–15; 08:45 am] 796–3602, Elaine.Lippmann@ Under § 314.161(a) (21 CFR
BILLING CODE 4164–01–P fda.hhs.gov. 314.161(a)), the Agency must determine
whether a listed drug was withdrawn
SUPPLEMENTARY INFORMATION: In 1984, from sale for reasons of safety or
DEPARTMENT OF HEALTH AND Congress enacted the Drug Price effectiveness: (1) Before an ANDA that
HUMAN SERVICES Competition and Patent Term refers to that listed drug may be
Restoration Act of 1984 (Pub. L. 98–417) approved, (2) whenever a listed drug is
Food and Drug Administration (the 1984 amendments), which
voluntarily withdrawn from sale and
authorized the approval of duplicate
[Docket No. FDA–2011–P–0482] ANDAs that refer to the listed drug have
versions of drug products approved
under an ANDA procedure. ANDA been approved, and (3) when a person
Determination That VAGIFEM applicants must, with certain petitions for such a determination under
asabaliauskas on DSK5VPTVN1PROD with NOTICES

(Estradiol) Vaginal Tablets, 25 exceptions, show that the drug for 21 CFR 10.25(a) and 10.30. Section
Micrograms, Was Not Withdrawn From which they are seeking approval 314.161(d) provides that if FDA
Sale for Reasons of Safety or contains the same active ingredient in determines that a listed drug was
Effectiveness the same strength and dosage form as withdrawn from sale for safety or
the ‘‘listed drug,’’ which is a version of effectiveness reasons, the Agency will
AGENCY: Food and Drug Administration,
HHS. the drug that was previously approved. initiate proceedings that could result in
ANDA applicants do not have to repeat the withdrawal of approval of the
ACTION: Notice.
the extensive clinical testing otherwise ANDAs that refer to the listed drug.

VerDate Sep<11>2014 18:19 May 21, 2015 Jkt 235001 PO 00000 Frm 00119 Fmt 4703 Sfmt 4703 E:\FR\FM\22MYN1.SGM 22MYN1

Document Created: 2015-12-15 15:46:15
Document Modified: 2015-12-15 15:46:15

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Contact		Elaine Lippmann, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6214, Silver Spring, MD 20993-0002, 301- 796-3602, [email protected]
FR Citation		80 FR 29720

80 FR 29720 - Determination That VAGIFEM (Estradiol) Vaginal Tablets, 25 Micrograms, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 99 (May 22, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration