Determination That DECADRON Tablets and Nine Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 22751-22752 [E9-11217]

Download as PDF Federal Register / Vol. 74, No. 92 / Thursday, May 14, 2009 / Notices except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Comments and petitions may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. SUMMARY: The Food and Drug Administration (FDA) has determined that the 10 drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness.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. 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 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. Sponsors of ANDAs 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 Under FDA regulations, a drug is withdrawn from the list if the agency withdraws or suspends approval of the drug’s NDA or ANDA for reasons of safety or effectiveness, or if FDA determines that the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 18–821 for REGLAN (metoclopramide) Oral Solution in the Federal Register of October 10, 2002 (67 FR 63107).) Drug 1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(i)) became effective: June 21, 1998. The applicant claims June 19, 1998, as the date the investigational new drug application (IND) became effective. However, FDA records indicate that the IND effective date was June 21, 1998, which was 30 days after FDA receipt of the IND. 2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the act: September 8, 2003. The applicant claims September 5, 2003, as the date the new drug application (NDA) for SENSIPAR (NDA 21–688) was initially submitted. However, FDA records indicate that NDA 21–688 was submitted on September 8, 2003, which is considered to be the initially submitted date. 3. The date the application was approved: March 8, 2004. FDA has verified the applicant’s claim that NDA 21–688 was approved on March 8, 2004. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the U.S. Patent and Trademark Office applies several statutory limitations in its calculations of the actual period for patent extension. In its applications for patent extension, this applicant seeks 449 days of patent term extension for U.S. Patent Nos. 6,011,068 and 6,313,146, and 627 days of patent term extension for U.S. Patent No. 6,211,244. Anyone with knowledge that any of the dates as published are incorrect may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments and ask for a redetermination by July 13, 2009. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by November 10, 2009. To meet its burden, the petition must contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41–42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Comments and petitions should be submitted to the Division of Dockets Management. Three copies of any mailed information are to be submitted, Applicant Dated: April 6, 2009. Jane A. Axelrad, Associate Director for Policy, Center for Drug Evaluation and Research [FR Doc. E9–11219 Filed 5–13–09; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–N–0188] Determination That DECADRON Tablets and Nine Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. Application No. pwalker on PROD1PC71 with NOTICES 22751 NDA 11–664 DECADRON (dexamethasone) Tablets, 0.5 milligram (mg) and 0.75 mg Merck & Co., P.O. Box 4, BLA–20, West Point, PA 19486 NDA 15–229 AMICAR (aminocaproic acid) Injection, 250 mg/milliliter (mL) Xanodyne Pharmaceuticals, Inc., One Riverfront Pl., Newport, KY 41071–4563 VerDate Nov<24>2008 17:37 May 13, 2009 Jkt 217001 PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 E:\FR\FM\14MYN1.SGM 14MYN1 22752 Federal Register / Vol. 74, No. 92 / Thursday, May 14, 2009 / Notices Application No. Drug Applicant NDA 16–636 NARCAN (naloxone hydrocholoride (HCl)) Injection, 0.02 mg/mL, 0.4 mg/mL, and 1 mg/ mL Endo Pharmaceuticals, Inc., 100 Painters Dr., Chadds Ford, PA 19317 NDA 16–929 FUDR (floxuridine) Injection, 500 mg/vial Hospira, Inc., 275 North Field Dr., Lake Forest, IL 60045 NDA 18–538 LOZOL (indapamide) Tablets, 1.25 mg and 2.5 mg Sanofi-Aventis U.S., 55 Corporate Blvd., P.O. Box 5925, Bridgewater, NJ 08807 NDA 18–821 REGLAN (metaclopramide HCl) Oral Solution, equivalent to (EQ) 5 mg base/5 mL A.H. Robins Co., c/o Wyeth-Ayerst Research, P.O. Box 8299, Philadelphia, PA 19101– 8299 NDA 18–831 TRACRIUM (atracurium besylate) Injection, 10 mg/mL Hospira, Inc. NDA 18–831 TRACRIUM (atracurium besylate) Preservative Free Injection, 10 mg/mL Do. NDA 19–080 PROSOM (estazolam) Tablets, 1 mg and 2 mg Abbott Laboratories, 200 Abbott Park Rd., D– 491, AP30–1E, Abbott Park, IL 60064– 6157 NDA 20–397 ZANAFLEX (tizanidine HCL) Tablets, EQ 2 mg base Acorda Therapeutics, 15 Skyline Dr., Hawthorne, NY 10532 FDA has reviewed its records and, under § 314.161, has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. Accordingly, the agency will continue to list the drug products 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 NDAs listed in this document are unaffected by the discontinued marketing of the products subject to those NDAs. Additional ANDAs that refer to these products may also be approved by the agency if they comply with relevant legal and regulatory requirements. If FDA determines that labeling for these drug products should be revised to meet current standards, the agency will advise ANDA applicants to submit such labeling. pwalker on PROD1PC71 with NOTICES Dated: May 6, 2009. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E9–11217 Filed 5–13–09; 8:45 am] BILLING CODE 4160–01–S VerDate Nov<24>2008 17:37 May 13, 2009 Jkt 217001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–D–0189] Guidance for Industry: Animal Generic Drug User Fees and Fee Waivers and Reductions; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance document for industry (#199) entitled ‘‘Animal Generic Drug User Fees and Fee Waivers and Reductions.’’ The purpose of this document is to provide guidance to industry on the Animal Generic Drug User Fee Act of 2008 (AGDUFA). FDA is issuing this final guidance document for immediate implementation consistent with the agency’s good guidance practices (GGPs). Interested persons may submit comments on agency guidances at any time. DATES: Submit written or electronic comments on agency guidances at any time. Submit written requests for single copies of the guidance document to the Communications Staff (HFV–12), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send one selfaddressed adhesive label to assist that office in processing your requests. ADDRESSES: PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 Submit written comments on the guidance document to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to https:// www.regulations.gov. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: David Newkirk, Center for Veterinary Medicine (HFV–100), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240–276–8307, email: dnewkirk@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background On August 14, 2008, AGDUFA (Public Law 110–316) was enacted. AGDUFA amends the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and requires FDA to assess and collect user fees for certain applications, products, and sponsors. It also requires the agency to grant a waiver from or a reduction of fees in certain circumstances. Under section 741(d) of the FD&C Act, when certain conditions are met, FDA will waive or reduce fees for generic new animal drugs intended solely to provide for a minor use or minor species indication. The purpose of the guidance document is to provide guidance on the types of fees FDA is authorized to collect under AGDUFA and how to request waivers and reductions of these fees. It describes the types of fees, the type of fee waiver or reduction E:\FR\FM\14MYN1.SGM 14MYN1

Agencies

[Federal Register Volume 74, Number 92 (Thursday, May 14, 2009)]
[Notices]
[Pages 22751-22752]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-11217]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0188]


Determination That DECADRON Tablets and Nine Other Drug Products 
Were 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) has determined that the 
10 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.

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 
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. Sponsors of ANDAs 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 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 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 18-821 for REGLAN 
(metoclopramide) Oral Solution in the Federal Register of October 10, 
2002 (67 FR 63107).)

------------------------------------------------------------------------
    Application No.                Drug                  Applicant
------------------------------------------------------------------------
NDA 11-664               DECADRON                 Merck & Co., P.O. Box
                          (dexamethasone)          4, BLA-20, West
                          Tablets, 0.5 milligram   Point, PA 19486
                          (mg) and 0.75 mg
------------------------------------------------------------------------
NDA 15-229               AMICAR (aminocaproic     Xanodyne
                          acid) Injection, 250     Pharmaceuticals,
                          mg/milliliter (mL)       Inc., One Riverfront
                                                   Pl., Newport, KY
                                                   41071-4563
------------------------------------------------------------------------

[[Page 22752]]

 
NDA 16-636               NARCAN (naloxone         Endo Pharmaceuticals,
                          hydrocholoride (HCl))    Inc., 100 Painters
                          Injection, 0.02 mg/mL,   Dr., Chadds Ford, PA
                          0.4 mg/mL, and 1 mg/mL   19317
------------------------------------------------------------------------
NDA 16-929               FUDR (floxuridine)       Hospira, Inc., 275
                          Injection, 500 mg/vial   North Field Dr., Lake
                                                   Forest, IL 60045
------------------------------------------------------------------------
NDA 18-538               LOZOL (indapamide)       Sanofi-Aventis U.S.,
                          Tablets, 1.25 mg and     55 Corporate Blvd.,
                          2.5 mg                   P.O. Box 5925,
                                                   Bridgewater, NJ 08807
------------------------------------------------------------------------
NDA 18-821               REGLAN (metaclopramide   A.H. Robins Co., c/o
                          HCl) Oral Solution,      Wyeth-Ayerst
                          equivalent to (EQ) 5     Research, P.O. Box
                          mg base/5 mL             8299, Philadelphia,
                                                   PA 19101-8299
------------------------------------------------------------------------
NDA 18-831               TRACRIUM (atracurium     Hospira, Inc.
                          besylate) Injection,
                          10 mg/mL
------------------------------------------------------------------------
NDA 18-831               TRACRIUM (atracurium     Do.
                          besylate) Preservative
                          Free Injection, 10 mg/
                          mL
------------------------------------------------------------------------
NDA 19-080               PROSOM (estazolam)       Abbott Laboratories,
                          Tablets, 1 mg and 2 mg   200 Abbott Park Rd.,
                                                   D-491, AP30-1E,
                                                   Abbott Park, IL 60064-
                                                   6157
------------------------------------------------------------------------
NDA 20-397               ZANAFLEX (tizanidine     Acorda Therapeutics,
                          HCL) Tablets, EQ 2 mg    15 Skyline Dr.,
                          base                     Hawthorne, NY 10532
------------------------------------------------------------------------

    FDA has reviewed its records and, under Sec.  314.161, has 
determined that the drug products listed in this document were not 
withdrawn from sale for reasons of safety or effectiveness. 
Accordingly, the agency will continue to list the drug products 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 NDAs listed in this document are 
unaffected by the discontinued marketing of the products subject to 
those NDAs. Additional ANDAs that refer to these products may also be 
approved by the agency if they comply with relevant legal and 
regulatory requirements. If FDA determines that labeling for these drug 
products should be revised to meet current standards, the agency will 
advise ANDA applicants to submit such labeling.

    Dated: May 6, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-11217 Filed 5-13-09; 8:45 am]
BILLING CODE 4160-01-S

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