Guidance for Industry on Diabetes Mellitus-Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes; Availability, 77724-77725 [E8-30086]

Download as PDF 77724 Federal Register / Vol. 73, No. 245 / Friday, December 19, 2008 / Notices Injection in the Federal Register of November 7, 2007 (72 FR 62858).) Application No. Drug Applicant NDA 6–799 RUBRAMIN PC (cyanocobalamin) Injection, 1 milligram (mg)/milliliter (mL) Bristol Myers Squibb Co., P.O. Box 4500, Princeton, NJ 08543–4500 NDA 10–060 FLORINEF (fludrocortisone acetate) Tablets, 0.1 mg King Pharmaceuticals, Inc., 501 Fifth St., Bristol, TN 37620 NDA 11–613 IONAMIN (phentermine resin complex) Extended-Release Capsules, equivalent to (EQ) 15 mg and 30 mg base UCB, Inc., 1950 Lake Park Dr., Smyrna, GA 30080 NDA 17–849 BRETHINE (terbutaline sulfate) Tablets, 2.5 mg and 5 mg AAIPharma, LLC, 2320 Scientific Park Dr., Wilmington, NC 28405 NDA 17–970 NOLVADEX (tamoxifen citrate) Tablets, EQ 10 mg and 20 mg base AstraZeneca Pharmaceuticals, 1800 Concord Pike, P.O. Box 8355, Wilmington, DE 19803–8355 NDA 19–058 TENORMIN (atenolol) Injection, 0.5 mg/mL Do. NDA 19–645 TORADOL (ketorolac tromethamine) Tablets, 10 mg Hoffman-La Roche, Inc., 340 Kingsland St., Nutley, NJ 07110–1199 NDA 19–778 PRINZIDE (hydrochlorothiazide and lisinopril) Tablets, 25mg/20mg Merck Research Laboratories, P.O. Box 1000, IG2C–50, North Wales, PA19454– 1009 NDA 19–816 ORUVAIL (ketoprofen) Extended-Release Capsules, 100 mg, 150 mg, and 200 mg Wyeth Pharmaceuticals, P.O. Box 8299, Philadelphia, PA 19101–8299 NDA 19–880 PARAPLATIN (carboplatin) for Injection, 50 mg/vial, 150 mg/vial, and 450 mg/vial Bristol Myers Squibb Co. NDA 50–582 DORYX (doxycycline hyclate) Delayed-Release Capsules, EQ 75 mg and 100 mg base F.H. Faulding and Co., c/o Warner Chilcott, Inc., Rockaway 80 Corporate Center, 100 Enterprise Dr., suite 280, Rockaway, NJ 07866 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has reviewed its records and, under § 314.161, has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness.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. VerDate Aug<31>2005 17:29 Dec 18, 2008 Jkt 217001 Dated: December 11, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–30154 Filed 12–18–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–D–0118] Guidance for Industry on Diabetes Mellitus—Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ‘‘Diabetes Mellitus—Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes.’’ This guidance makes PO 00000 Frm 00134 Fmt 4703 Sfmt 4703 recommendations about how to demonstrate that a new antidiabetic therapy to treat type 2 diabetes is not associated with an unacceptable increase in cardiovascular risk. We are issuing this guidance for immediate implementation to ensure that relevant issues related to minimizing cardiovascular risk are considered by all sponsors who have ongoing drug development programs for type 2 diabetes. DATES: Submit written or electronic comments on agency guidances at any time. ADDRESSES: Submit written requests for single copies of this 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. Submit written comments on the guidance to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit E:\FR\FM\19DEN1.SGM 19DEN1 Federal Register / Vol. 73, No. 245 / Friday, December 19, 2008 / Notices electronic comments to https:// www.regulations.gov. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: Mary Parks, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 3362, Silver Spring, MD 20993–0002, 301–796–2290. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry entitled ‘‘Diabetes Mellitus—Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes.’’ Diabetes mellitus is associated with an increased risk of cardiovascular disease. Reducing longterm cardiovascular complications in patients with diabetes should be an important goal of disease management. There are compelling data in patients with type 2 diabetes supporting a reduced risk of microvascular complications with improved long-term glycemic control. This guidance makes recommendations about how to demonstrate that a new antidiabetic therapy to treat type 2 diabetes is not associated with an unacceptable increase in cardiovascular risk. On March 3, 2008, FDA issued the draft guidance for industry entitled ‘‘Diabetes Mellitus: Developing Drugs and Therapeutic Biologics for Treatment and Prevention’’ (73 FR 11420). On July 1 and 2, 2008, the Endocrinologic and Metabolic Drugs Advisory Committee met to discuss the role of cardiovascular assessment in the premarketing and postmarketing settings for drugs and therapeutic biologics developed for the treatment of type 2 diabetes mellitus. After considering the discussion at this meeting as well as other available data and information, we have determined that concerns about cardiovascular risk should be more thoroughly addressed during drug development. We are issuing this guidance to ensure that our recommendations reach all sponsors who may submit applications for approval of drugs to treat type 2 diabetes mellitus. We are issuing this level 1 guidance for immediate implementation, consistent with FDA’s good guidance practices regulation (21 CFR 10.115). FDA is not seeking comment before implementing this guidance because of the need to immediately notify sponsors with ongoing development programs of the need to address cardiovascular risk in ongoing drug development programs. VerDate Aug<31>2005 17:29 Dec 18, 2008 Jkt 217001 If FDA receives comments on this guidance, it will consider the comments and incorporate final recommendations into the final version of the March 2008 draft guidance. This guidance represents the agency’s current thinking on evaluating cardiovascular risk in new antidiabetic therapies to treat type 2 diabetes. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. II. The Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– 3520). The collections of information in 21 CFR part 312 have been approved under 0910–0014, and the collections of information in 21 CFR part 314 have been approved under 0910–0001. III. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Please note that on January 15, 2008, the FDA Division of Dockets Management Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic comments or submissions will be accepted by FDA only through FDMS at https://www.regulations.gov. IV. Electronic Access Persons with access to the Internet may obtain the document at either https://www.fda.gov/cder/guidance/ index.htm or https:// www.regulations.gov. PO 00000 Frm 00135 Fmt 4703 Sfmt 4703 77725 Dated: December 1, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–30086 Filed 12–17–08; 11:15 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Center for Scientific Review, Special Emphasis Panel, Prevention, Interventions: Alcohol, Diabetes and Smoking. Date: January 6, 2009. Time: 1 p.m. to 2:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892. (Telephone Conference Call) Contact Person: Anna L. Riley, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3114, MSC 7759, Bethesda, MD 20892, 301–435– 2889, rileyann@csr.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center for Scientific Review, Special Emphasis Panel, Member Conflicts in Microbiology. Date: January 8–9, 2009. Time: 8:30 a.m. to 3 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892. (Virtual Meeting) Contact Person: Guangyong Ji, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3211, MSC 7808, Bethesda, MD 20892, 301–435– 1146. This notice is being published less than 15 days prior to the meeting due to the timing E:\FR\FM\19DEN1.SGM 19DEN1

Agencies

[Federal Register Volume 73, Number 245 (Friday, December 19, 2008)]
[Notices]
[Pages 77724-77725]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-30086]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0118]


Guidance for Industry on Diabetes Mellitus--Evaluating 
Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 
Diabetes; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry entitled ``Diabetes Mellitus--
Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat 
Type 2 Diabetes.'' This guidance makes recommendations about how to 
demonstrate that a new antidiabetic therapy to treat type 2 diabetes is 
not associated with an unacceptable increase in cardiovascular risk. We 
are issuing this guidance for immediate implementation to ensure that 
relevant issues related to minimizing cardiovascular risk are 
considered by all sponsors who have ongoing drug development programs 
for type 2 diabetes.

DATES: Submit written or electronic comments on agency guidances at any 
time.

ADDRESSES: Submit written requests for single copies of this 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. 
Submit written comments on the guidance to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Submit

[[Page 77725]]

electronic comments to https://www.regulations.gov. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the guidance 
document.

FOR FURTHER INFORMATION CONTACT: Mary Parks, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 22, rm. 3362, Silver Spring, MD 20993-0002, 301-796-2290.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Diabetes Mellitus--Evaluating Cardiovascular Risk in New 
Antidiabetic Therapies to Treat Type 2 Diabetes.'' Diabetes mellitus is 
associated with an increased risk of cardiovascular disease. Reducing 
long-term cardiovascular complications in patients with diabetes should 
be an important goal of disease management. There are compelling data 
in patients with type 2 diabetes supporting a reduced risk of 
microvascular complications with improved long-term glycemic control. 
This guidance makes recommendations about how to demonstrate that a new 
antidiabetic therapy to treat type 2 diabetes is not associated with an 
unacceptable increase in cardiovascular risk.
    On March 3, 2008, FDA issued the draft guidance for industry 
entitled ``Diabetes Mellitus: Developing Drugs and Therapeutic 
Biologics for Treatment and Prevention'' (73 FR 11420). On July 1 and 
2, 2008, the Endocrinologic and Metabolic Drugs Advisory Committee met 
to discuss the role of cardiovascular assessment in the premarketing 
and postmarketing settings for drugs and therapeutic biologics 
developed for the treatment of type 2 diabetes mellitus. After 
considering the discussion at this meeting as well as other available 
data and information, we have determined that concerns about 
cardiovascular risk should be more thoroughly addressed during drug 
development. We are issuing this guidance to ensure that our 
recommendations reach all sponsors who may submit applications for 
approval of drugs to treat type 2 diabetes mellitus.
    We are issuing this level 1 guidance for immediate implementation, 
consistent with FDA's good guidance practices regulation (21 CFR 
10.115). FDA is not seeking comment before implementing this guidance 
because of the need to immediately notify sponsors with ongoing 
development programs of the need to address cardiovascular risk in 
ongoing drug development programs. If FDA receives comments on this 
guidance, it will consider the comments and incorporate final 
recommendations into the final version of the March 2008 draft 
guidance.
    This guidance represents the agency's current thinking on 
evaluating cardiovascular risk in new antidiabetic therapies to treat 
type 2 diabetes. It does not create or confer any rights for or on any 
person and does not operate to bind FDA or the public. An alternative 
approach may be used if such approach satisfies the requirements of the 
applicable statutes and regulations.

II. The Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR part 312 have been approved under 
0910-0014, and the collections of information in 21 CFR part 314 have 
been approved under 0910-0001.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at https://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
either https://www.fda.gov/cder/guidance/index.htm or https://
www.regulations.gov.

    Dated: December 1, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-30086 Filed 12-17-08; 11:15 am]
BILLING CODE 4160-01-S

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