Determination That DECA-DURABOLIN (Nandrolone Decanoate) Injection, 200 Milligrams/Milliliter, 1 Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 48351-48352 [2010-19698]

Download as PDF Federal Register / Vol. 75, No. 153 / Tuesday, August 10, 2010 / Notices 48351 TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1 21 CFR Section Annual Frequency per Recordkeeping No. of Recordkeepers Total Annual Records Hours per Record Total Hours 106.100 5 10 50 400 20,000 107.50(c)(3) 3 10 30 300 9,000 Total 29,000 1 There are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 3.—ESTIMATED ANNUAL THIRD PARTY DISCLOSURE BURDEN1 21 CFR Section No. of Respondents 107.10(a) and 107.20 sroberts on DSKB9S0YB1PROD with NOTICES 1 There Annual Frequency of Disclosure 5 Total Annual Disclosures 13 Hours per Disclosure 65 Total Hours 8 520 are no capital costs or operating and maintenance costs associated with this collection of information. In compiling these estimates, FDA consulted its records of the number of infant formula submissions received in the past. All infant formula submissions to FDA may be provided in electronic format. The hours per response reporting estimates are based on FDA’s experience with similar programs and information received from industry. FDA estimates that it will receive 13 reports from 5 manufacturers annually under section 412(d) of the act, for a total annual response of 65 reports. Each report is estimated to take 10 hours per response for a total of 650 hours. FDA also estimates that it will receive one notification under § 106.120(b). The notification is expected to take 4 hours per response, for a total of 4 hours. For exempt infant formula, FDA estimates that it will receive 2 reports from 3 manufacturers annually under §§ 107.50(b)(3) and (b)(4), for a total annual response of 6 reports. Each report is estimated to take 4 hours per response for a total of 24 hours. FDA also estimates that it will receive one notification under § 107.50(e)(2). The notification is expected to take four hours per response, for a total of four hours. FDA estimates that 5 firms will expend approximately 20,000 hours per year to fully satisfy the recordkeeping requirements in § 106.100. It is estimated that 3 firms will expend approximately 9,000 hours per year to fully satisfy the recordkeeping requirements in § 107.50(c)(3). FDA estimates that compliance with the labeling requirements of §§ 107.10(a) and 107.20 will require 520 hours annually by 5 manufacturers. VerDate Mar<15>2010 16:26 Aug 09, 2010 Jkt 220001 Dated: August 5, 2010. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2010–19640 Filed 8–9–10; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–P–0218] Determination That DECA-DURABOLIN (Nandrolone Decanoate) Injection, 200 Milligrams/Milliliter, 1 Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing its determination that DECA-DURABOLIN (nandrolone decanoate) Injection, 200 milligrams/milliliter (mg/mL), 1 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 nandrolone decanoate, 200 mg/mL, 1 mL, if all other legal and regulatory requirements are met. SUMMARY: FOR FURTHER INFORMATION CONTACT: Nikki Mueller, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6312, 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 (Public Law 98– PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 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 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). Under 21 CFR 314.161(a)(1), the agency must determine 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. FDA may not approve an ANDA that does not refer to a listed drug. DECA-DURABOLIN (nandrolone decanoate) Injection is the subject of NDA 13–132, held by Organon, Inc. E:\FR\FM\10AUN1.SGM 10AUN1 48352 Federal Register / Vol. 75, No. 153 / Tuesday, August 10, 2010 / Notices sroberts on DSKB9S0YB1PROD with NOTICES (Organon), and was initially approved on October 5, 1962. Under the Drug Efficacy Study Implementation (DESI), FDA concluded that nandrolone decanoate was effective for the indications described in the Federal Register notice published on July 15, 1983 (DESI 7630, 48 FR 32394). DECADURABOLIN is an anabolic steroid indicated for the management of the anemia of renal insufficiency and has been shown to increase hemoglobin and red cell mass. Organon notified FDA in a letter dated May 21, 2002, that it was no longer marketing DECADURABOLIN (nandrolone decanoate) Injection, 200 mg/mL, 1 mL, and the drug product was moved to the ‘‘Discontinued Drug Product List’’ section of the Orange Book. PharmaForce, Inc., submitted a citizen petition dated May 7, 2009 (Docket No. FDA–2009–P–0218), under 21 CFR 10.30 requesting that the agency determine whether DECA-DURABOLIN (nandrolone decanoate) Injection, 200 mg/mL, 1 mL, was withdrawn from sale for reasons of safety or effectiveness. FDA has reviewed its records and, under § 314.161, has determined that DECA-DURABOLIN (nandrolone decanoate) Injection, 200 mg/mL, 1 mL, was not withdrawn from sale for reasons of safety or effectiveness. The petitioner identified no data or other information suggesting that DECA-DURABOLIN (nandrolone decanoate) Injection, 200 mg/mL, 1 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 DECADURABOLIN (nandrolone decanoate) Injection, 200 mg/mL, 1 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 DECA-DURABOLIN (nandrolone decanoate) Injection, 200 mg/mL, 1 mL, may be approved by the agency if all other legal and regulatory requirements for 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: August 5, 2010. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2010–19698 Filed 8–9–10; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–N–0391] Determination That MOTRIN (Ibuprofen) Tablets and Four Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) has determined that the five drug products listed in this document were 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 these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements. SUMMARY: FOR FURTHER INFORMATION CONTACT: Olivia Pritzlaff, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6308, 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 (Public Law 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 Application No. 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 (the 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 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). Under § 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 reasons of safety or effectiveness, the agency will initiate proceedings that could result in the withdrawal of approval of the ANDAs that refer to the listed drug. FDA has become aware that the drug products listed in the table in this document are no longer being marketed. (As requested by the applicant, FDA withdrew approval of NDA 18–354 for ORTHO–NOVUM 10/11–21 and 10/11– 28 (ethinyl estradiol; norethindrone) Tablets in the Federal Register of February 11, 2009 (74 FR 6896).) Drug Applicant NDA 17–463 MOTRIN (ibuprofen) Tablets, 300 milligrams (mg), 400 mg, 600 mg, and 800 mg McNeil Consumer Healthcare, 7050 Camp Hill Rd., Fort Washington, PA 19034 NDA 18–303 LOPRESSOR HCT (hydrochlorothiazide; metoprolol tartrate ) Tablets, 50 mg; 100 mg Novartis Pharmaceuticals Corp., 59 Rte. 10, East Hanover, NJ 07936–1080 VerDate Mar<15>2010 16:26 Aug 09, 2010 Jkt 220001 PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 E:\FR\FM\10AUN1.SGM 10AUN1

Agencies

[Federal Register Volume 75, Number 153 (Tuesday, August 10, 2010)]
[Notices]
[Pages 48351-48352]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-19698]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-P-0218]


Determination That DECA-DURABOLIN (Nandrolone Decanoate) 
Injection, 200 Milligrams/Milliliter, 1 Milliliter, 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) is announcing its 
determination that DECA-DURABOLIN (nandrolone decanoate) Injection, 200 
milligrams/milliliter (mg/mL), 1 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 nandrolone 
decanoate, 200 mg/mL, 1 mL, if all other legal and regulatory 
requirements are met.

FOR FURTHER INFORMATION CONTACT: Nikki Mueller, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 6312, 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 (Public Law 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 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). Under 21 CFR 314.161(a)(1), the agency 
must determine 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. FDA may not approve an ANDA that does not 
refer to a listed drug.
    DECA-DURABOLIN (nandrolone decanoate) Injection is the subject of 
NDA 13-132, held by Organon, Inc.

[[Page 48352]]

(Organon), and was initially approved on October 5, 1962. Under the 
Drug Efficacy Study Implementation (DESI), FDA concluded that 
nandrolone decanoate was effective for the indications described in the 
Federal Register notice published on July 15, 1983 (DESI 7630, 48 FR 
32394). DECA-DURABOLIN is an anabolic steroid indicated for the 
management of the anemia of renal insufficiency and has been shown to 
increase hemoglobin and red cell mass. Organon notified FDA in a letter 
dated May 21, 2002, that it was no longer marketing DECA-DURABOLIN 
(nandrolone decanoate) Injection, 200 mg/mL, 1 mL, and the drug product 
was moved to the ``Discontinued Drug Product List'' section of the 
Orange Book. PharmaForce, Inc., submitted a citizen petition dated May 
7, 2009 (Docket No. FDA-2009-P-0218), under 21 CFR 10.30 requesting 
that the agency determine whether DECA-DURABOLIN (nandrolone decanoate) 
Injection, 200 mg/mL, 1 mL, was withdrawn from sale for reasons of 
safety or effectiveness.
    FDA has reviewed its records and, under Sec.  314.161, has 
determined that DECA-DURABOLIN (nandrolone decanoate) Injection, 200 
mg/mL, 1 mL, was not withdrawn from sale for reasons of safety or 
effectiveness. The petitioner identified no data or other information 
suggesting that DECA-DURABOLIN (nandrolone decanoate) Injection, 200 
mg/mL, 1 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 
DECA-DURABOLIN (nandrolone decanoate) Injection, 200 mg/mL, 1 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 DECA-DURABOLIN 
(nandrolone decanoate) Injection, 200 mg/mL, 1 mL, may be approved by 
the agency if all other legal and regulatory requirements for 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: August 5, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-19698 Filed 8-9-10; 8:45 am]
BILLING CODE 4160-01-S
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.