Determination That VESANOID (Tretinoin) Capsules, 10 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 55796-55797 [2010-22807]

Download as PDF jlentini on DSKJ8SOYB1PROD with NOTICES 55796 Federal Register / Vol. 75, No. 177 / Tuesday, September 14, 2010 / Notices Gamma-Dynacare Medical Laboratories*, A Division of the Gamma-Dynacare Laboratory Partnership, 245 Pall Mall Street, London, ONT, Canada N6A 1P4, 519– 679–1630. Laboratory Corporation of America Holdings, 7207 N. Gessner Road, Houston, TX 77040, 713–856–8288/ 800–800–2387. Laboratory Corporation of America Holdings, 69 First Ave., Raritan, NJ 08869, 908–526–2400/800–437–4986 (Formerly: Roche Biomedical Laboratories, Inc.). Laboratory Corporation of America Holdings, 1904 Alexander Drive, Research Triangle Park, NC 27709, 919–572–6900/800–833–3984 (Formerly: LabCorp Occupational Testing Services, Inc., CompuChem Laboratories, Inc.; CompuChem Laboratories, Inc., A Subsidiary of Roche Biomedical Laboratory; Roche CompuChem Laboratories, Inc., A Member of the Roche Group). Laboratory Corporation of America Holdings, 1120 Main Street, Southaven, MS 38671, 866–827–8042/ 800–233–6339 (Formerly: LabCorp Occupational Testing Services, Inc.; MedExpress/National Laboratory Center). LabOne, Inc. d/b/a Quest Diagnostics, 10101 Renner Blvd., Lenexa, KS 66219, 913–888–3927/800–873–8845 (Formerly: Quest Diagnostics Incorporated; LabOne, Inc.; Center for Laboratory Services, a Division of LabOne, Inc.,). Maxxam Analytics*, 6740 Campobello Road, Mississauga, ON, Canada L5N 2L8, 905–817–5700 (Formerly: Maxxam Analytics Inc., NOVAMANN (Ontario), Inc.). MedTox Laboratories, Inc., 402 W. County Road D, St. Paul, MN 55112, 651–636–7466/800–832–3244. MetroLab-Legacy Laboratory Services, 1225 NE 2nd Ave., Portland, OR 97232, 503–413–5295/800–950–5295. Minneapolis Veterans Affairs Medical Center, Forensic Toxicology Laboratory, 1 Veterans Drive, Minneapolis, MN 55417, 612–725– 2088. National Toxicology Laboratories, Inc., 1100 California Ave., Bakersfield, CA 93304, 661–322–4250/800–350–3515. One Source Toxicology Laboratory, Inc., 1213 Genoa-Red Bluff, Pasadena, TX 77504, 888–747–3774 (Formerly: University of Texas Medical Branch, Clinical Chemistry Division; UTMB Pathology-Toxicology Laboratory). Pacific Toxicology Laboratories, 9348 DeSoto Ave., Chatsworth, CA 91311, 800–328–6942 (Formerly: Centinela VerDate Mar<15>2010 16:38 Sep 13, 2010 Jkt 220001 Hospital Airport Toxicology Laboratory). Pathology Associates Medical Laboratories, 110 West Cliff Dr., Spokane, WA 99204, 509–755–8991/ 800–541–7891x7. Phamatech, Inc., 10151 Barnes Canyon Road, San Diego, CA 92121, 858–643– 5555. Quest Diagnostics Incorporated, 1777 Montreal Circle, Tucker, GA 30084, 800–729–6432 (Formerly: SmithKline Beecham Clinical Laboratories; SmithKline Bio-Science Laboratories). Quest Diagnostics Incorporated, 400 Egypt Road, Norristown, PA 19403, 610–631–4600/877–642–2216 (Formerly: SmithKline Beecham Clinical Laboratories; SmithKline BioScience Laboratories). Quest Diagnostics Incorporated, 8401 Fallbrook Ave., West Hills, CA 91304, 800–877–2520 (Formerly: SmithKline Beecham Clinical Laboratories). S.E.D. Medical Laboratories, 5601 Office Blvd., Albuquerque, NM 87109, 505– 727–6300/800–999–5227. South Bend Medical Foundation, Inc., 530 N. Lafayette Blvd., South Bend, IN 46601, 574–234–4176 x1276. Southwest Laboratories, 4625 E. Cotton Center Boulevard, Suite 177, Phoenix, AZ 85040, 602–438–8507/800–279– 0027. St. Anthony Hospital Toxicology Laboratory, 1000 N. Lee St., Oklahoma City, OK 73101, 405–272– 7052. STERLING Reference Laboratories, 2617 East L Street, Tacoma, Washington 98421, 800–442–0438. Toxicology & Drug Monitoring Laboratory, University of Missouri Hospital & Clinics, 301 Business Loop 70 West, Suite 208, Columbia, MO 65203, 573–882–1273. Toxicology Testing Service, Inc., 5426 N.W. 79th Ave., Miami, FL 33166, 305–593–2260. U.S. Army Forensic Toxicology Drug Testing Laboratory, 2490 Wilson St., Fort George G. Meade, MD 20755– 5235, 301–677–7085. *The Standards Council of Canada (SCC) voted to end its Laboratory Accreditation Program for Substance Abuse (LAPSA) effective May 12, 1998. Laboratories certified through that program were accredited to conduct forensic urine drug testing as required by U.S. Department of Transportation (DOT) regulations. As of that date, the certification of those accredited Canadian laboratories will continue under DOT authority. The responsibility for conducting quarterly performance testing plus periodic on-site inspections of those LAPSA-accredited laboratories was transferred to the U.S. HHS, with PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 the HHS’ NLCP contractor continuing to have an active role in the performance testing and laboratory inspection processes. Other Canadian laboratories wishing to be considered for the NLCP may apply directly to the NLCP contractor just as U.S. laboratories do. Upon finding a Canadian laboratory to be qualified, HHS will recommend that DOT certify the laboratory (Federal Register, July 16, 1996) as meeting the minimum standards of the Mandatory Guidelines published in the Federal Register on April 13, 2004 (69 FR 19644). After receiving DOT certification, the laboratory will be included in the monthly list of HHScertified laboratories and participate in the NLCP certification maintenance program. Dated: September 8, 2010. Elaine Parry, Director, Office of Management, Technology, and Operations, SAMHSA. [FR Doc. 2010–22818 Filed 9–13–10; 8:45 am] BILLING CODE 4160–20–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–P–0157] Determination That VESANOID (Tretinoin) Capsules, 10 Milligrams, 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 VESANOID (tretinoin) Capsules, 10 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of the abbreviated new drug application (ANDA) that refers 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: Molly Flannery, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6237, Silver Spring, MD 20993–0002, 301– 796–3543. SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98– SUMMARY: E:\FR\FM\14SEN1.SGM 14SEN1 jlentini on DSKJ8SOYB1PROD with NOTICES Federal Register / Vol. 75, No. 177 / Tuesday, September 14, 2010 / Notices 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 § 314.161(a)(1) (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. VESANOID (tretinoin) Capsules, 10 mg, are the subject of NDA 20–438, held by Hoffman-La Roche Inc. (Roche), and initially approved on November 22, 1995. VESANOID is indicated for the ‘‘induction of remission in patients with acute promyelocytic leukemia (APL), French-American-British (FAB) classification M3 (including the M3 variant), characterized by the presence of the t(15;17) translocation and/or the presence of the PML/RARa [promyelocytic leukemia/retinoic acid receptor alpha] gene who are refractory to, or who have relapsed from, anthracycline chemotherapy, or for whom anthracycline-based chemotherapy is contraindicated’’ (VESANOID labeling). In a letter dated December 2, 2009, Roche notified FDA that VESANOID (tretinoin) Capsules, 10 mg, were being discontinued, and FDA moved the drug product to the ‘‘Discontinued Drug VerDate Mar<15>2010 16:38 Sep 13, 2010 Jkt 220001 Product List’’ section of the Orange Book. There is one approved ANDA for tretinoin capsules, 10 mg (ANDA No. 77–684); this drug product is listed in the Orange Book and, following the discontinuation of VESANOID, was designated as the reference listed drug to which new ANDAs should refer. Rakoczy Molino Mazzochi Siwik LLP submitted a citizen petition dated March 17, 2010 (Docket No. FDA–2010– P–0157), under 21 CFR 10.30, requesting that the agency determine whether VESANOID (tretinoin) Capsules, 10 mg, were withdrawn from sale for reasons of safety or effectiveness. After considering the citizen petition and reviewing agency records, FDA has determined under § 314.161 that VESANOID (tretinoin) Capsules, 10 mg, were not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that VESANOID (tretinoin) Capsules, 10 mg, were withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of VESANOID (tretinoin) Capsules, 10 mg, from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events and have 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 VESANOID (tretinoin) Capsules, 10 mg, 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. FDA will not begin procedures to withdraw approval of the approved ANDA that refers to VESANOID. Additional ANDAs for tretinoin capsules, 10 mg, may also be approved by the agency as long as they meet all other legal and regulatory requirements for the approval of ANDAs. 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: September 8, 2010. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2010–22807 Filed 9–13–10; 8:45 am] BILLING CODE 4160–01–S PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 55797 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–D–0462] Draft Guidance for Industry on Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Agents for Treatment; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ‘‘Chronic Hepatitis C Virus Infection: Developing DirectActing Antiviral Agents for Treatment.’’ The purpose of this guidance is to assist sponsors in all phases of development of direct-acting antiviral agents (DAAs), defined as agents that interfere with specific steps in the hepatitis C virus (HCV) replication cycle. The guidance outlines the types of nonclinical studies and clinical trials recommended throughout the drug development process to support approval of treatments for chronic hepatitis C (CHC), including in patients with compensated and decompensated cirrhosis and those co-infected with human immunodeficiency virus (HIV). The guidance also addresses preapproval access in the form of treatment investigational new drug applications (INDs) and intermediate-sized safety protocols. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by November 15, 2010. ADDRESSES: Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993–0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. Submit electronic comments on the draft guidance to https:// www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. SUMMARY: E:\FR\FM\14SEN1.SGM 14SEN1

Agencies

[Federal Register Volume 75, Number 177 (Tuesday, September 14, 2010)]
[Notices]
[Pages 55796-55797]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-22807]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-P-0157]


Determination That VESANOID (Tretinoin) Capsules, 10 Milligrams, 
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 
VESANOID (tretinoin) Capsules, 10 milligrams (mg), were not withdrawn 
from sale for reasons of safety or effectiveness. This determination 
means that FDA will not begin procedures to withdraw approval of the 
abbreviated new drug application (ANDA) that refers 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:  Molly Flannery, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 6237, Silver Spring, MD 20993-0002, 301-
796-3543.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price 
Competition and Patent Term Restoration Act of 1984 (Public Law 98-

[[Page 55797]]

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 Sec.  314.161(a)(1) (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.
    VESANOID (tretinoin) Capsules, 10 mg, are the subject of NDA 20-
438, held by Hoffman-La Roche Inc. (Roche), and initially approved on 
November 22, 1995. VESANOID is indicated for the ``induction of 
remission in patients with acute promyelocytic leukemia (APL), French-
American-British (FAB) classification M3 (including the M3 variant), 
characterized by the presence of the t(15;17) translocation and/or the 
presence of the PML/RAR[agr] [promyelocytic leukemia/retinoic acid 
receptor alpha] gene who are refractory to, or who have relapsed from, 
anthracycline chemotherapy, or for whom anthracycline-based 
chemotherapy is contraindicated'' (VESANOID labeling).
    In a letter dated December 2, 2009, Roche notified FDA that 
VESANOID (tretinoin) Capsules, 10 mg, were being discontinued, and FDA 
moved the drug product to the ``Discontinued Drug Product List'' 
section of the Orange Book. There is one approved ANDA for tretinoin 
capsules, 10 mg (ANDA No. 77-684); this drug product is listed in the 
Orange Book and, following the discontinuation of VESANOID, was 
designated as the reference listed drug to which new ANDAs should 
refer.
    Rakoczy Molino Mazzochi Siwik LLP submitted a citizen petition 
dated March 17, 2010 (Docket No. FDA-2010-P-0157), under 21 CFR 10.30, 
requesting that the agency determine whether VESANOID (tretinoin) 
Capsules, 10 mg, were withdrawn from sale for reasons of safety or 
effectiveness.
    After considering the citizen petition and reviewing agency 
records, FDA has determined under Sec.  314.161 that VESANOID 
(tretinoin) Capsules, 10 mg, were not withdrawn for reasons of safety 
or effectiveness. The petitioner has identified no data or other 
information suggesting that VESANOID (tretinoin) Capsules, 10 mg, were 
withdrawn for reasons of safety or effectiveness. We have carefully 
reviewed our files for records concerning the withdrawal of VESANOID 
(tretinoin) Capsules, 10 mg, from sale. We have also independently 
evaluated relevant literature and data for possible postmarketing 
adverse events and have 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 VESANOID (tretinoin) 
Capsules, 10 mg, 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. FDA will not 
begin procedures to withdraw approval of the approved ANDA that refers 
to VESANOID. Additional ANDAs for tretinoin capsules, 10 mg, may also 
be approved by the agency as long as they meet all other legal and 
regulatory requirements for the approval of ANDAs. 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: September 8, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-22807 Filed 9-13-10; 8:45 am]
BILLING CODE 4160-01-S
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