Determination That Brethine (Terbutaline Sulfate) Injection Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 39629-39630 [E7-13950]

Download as PDF 39629 Federal Register / Vol. 72, No. 138 / Thursday, July 19, 2007 / Notices 1. The impact on physicians, their patients, and their practices of the disclosure of still uncertain, emerging risks associated with medical products. 2. How physicians currently receive and ideally would like to receive new risk information about medical products (for example, at what level of certainty regarding causality and through what communication channels). 3. How physicians perceive the trustworthiness of FDA and other potential sources of risk information, including product sponsors, medical societies, and the media. 4. What FDA might do to increase the likelihood that respondents will report to FDA or to manufacturers serious patient reactions that might be side effects of using medical products. In the Federal Register of July 31, 2006 (71 FR 43200), FDA published a 60-day notice requesting public comment on the information collection provisions. Comments were received from five public entities consisting of two corporations and three associations. Comments supported FDA’s belief in the value of conducting the survey. None of the comments addressed specific survey questions. FDA agrees with the comments concerning the study methodology. • Questions should be clear and not leading or ambiguous. • FDA should conduct pre-tests. • The sample size will be sufficient to provide statistically relevant information for the two stratified segments of physicians and the combination of these segments. After carefully considering them, FDA determined that other comments would require changes that would reduce the utility of study results by diluting the study’s focus, omitting important topic areas, or making the questionnaire excessively long and thereby reducing response rates. These comments included the following: • Including other health care providers ‘‘who prescribe drugs.’’ • Getting more detail about particular source categories. • Omitting questions about how respondents report adverse events or product problems. FDA agreed with the value of adding some questions that ask about the inclusion of other information, including benefits, in communications about newly emerging product risks. FDA also received feedback from experts in the fields of risk communication and health literacy on the study and the proposed questionnaire at an ‘‘Effective Risk Communication’’ Think Tank Workshop. FDA revised the survey questionnaire in response to this feedback, the feedback received through the public comments, and eight cognitive interviews conducted in May 2007. TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours 27 (Pretests) 1 27 .3 8.1 1,000 (Screener) 1 1,000 .025 25.0 900 (Survey) 1 900 .25 225.0 Total 1 There 258.1 are no capital costs or operating and maintenance costs associated with this collection of information. These estimates are based on FDA’s and the contractor’s experience with previous surveys. The respondents are divided into two groups: Primary care physicians and specialist physicians. We are basing this estimate on 90 percent of the screened physicians being eligible to participate in the survey. Prior to administering the survey with the entire sample, FDA plans to conduct pretests with up to 27 physicians; these are meant to evaluate the clarity and consistency of the survey questionnaire and interview protocol. Dated: July 13, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7–14015 Filed 7–18–07; 8:45 am] cprice-sewell on PROD1PC66 with NOTICES BILLING CODE 4160–01–S VerDate Aug<31>2005 15:31 Jul 18, 2007 Jkt 211001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007P–0052] Determination That Brethine (Terbutaline Sulfate) Injection 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 Brethine (Terbutaline Sulfate) Injection was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for terbutaline sulfate injection if all other legal and regulatory requirements are met. FOR FURTHER INFORMATION CONTACT: Carol E. Drew, Center for Drug Evaluation and Research (HFD–7), Food PO 00000 Frm 00025 Fmt 4703 Sfmt 4703 and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–594– 2041. 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 under a new drug application (NDA). ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of an 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 SUPPLEMENTARY INFORMATION: E:\FR\FM\19JYN1.SGM 19JYN1 cprice-sewell on PROD1PC66 with NOTICES 39630 Federal Register / Vol. 72, No. 138 / Thursday, July 19, 2007 / Notices 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 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). Regulations also provide that the agency must make a determination as to 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 (§ 314.161(a)(1) (21 CFR 314.161(a)(1))). FDA may not approve an ANDA that does not refer to a listed drug. On February 9, 2007, West-ward Pharmaceutical Corp. (West-ward), on behalf of Hikma Farmaceutica (Portugal), S.A., submitted a citizen petition (Docket No. 2007P–0052/CP1) to FDA under 21 CFR 10.30. The petition requests that the agency determine whether Brethine (terbutaline sulfate) injection (NDA 18–571), manufactured by AaiPharma, was withdrawn from sale for reasons of safety or effectiveness. AaiPharma ceased manufacture of Brethine injection and it was moved from the prescription drug product list to the ‘‘Discontinued Drug Product List’’ section of the Orange Book in August of 2006. Brethine injection was first approved in 1981; this approval was for a glass ampoule container closure system. In 2004 AaiPharma received approval of a glass vial container closure system for a Brethine injection formulation that contained 0.055 percent disodium edetate. When Brethine injection was discontinued, an approved generic was chosen as the replacement reference listed drug. The replacement reference listed drug does not contain 0.055 disodium edetate and is based on the original glass ampoule formulation. Therefore, West-ward requests that the agency make a determination that the reformulated version of Brethine injection was not withdrawn for safety or efficacy reasons. FDA has reviewed its records and, under § 314.161, has determined that Brethine (terbutaline sulfate) injection was not withdrawn from sale for reasons of safety or effectiveness. The petitioner identified no data or other information suggesting that Brethine containing 0.055 disodium edetate was withdrawn VerDate Aug<31>2005 15:31 Jul 18, 2007 Jkt 211001 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. Furthermore we have determined that the change in formulation was not for safety or efficacy reasons. Our files indicate that disodium edetate was added as a protectant against certain oxidationderived terbutaline impurities and degradants when the manufacturing site and container closure system were changed. Accordingly, the agency will continue to list terbutaline sulfate injection 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 terbutaline sulfate injection 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: July 12, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7–13950 Filed 7–18–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007D–0201] Draft Guidance for Industry and Food and Drug Administration Staff; Premarket Notification Submissions for Medical Devices That Include Antimicrobial Agents; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ‘‘Premarket Notification (510(k)) Submissions for Medical Devices That Include Antimicrobial Agents.’’ This draft guidance is intended to assist device manufacturers interested in preparing premarket notification (510(k)) submissions for their medical devices that include antimicrobial PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 agents. This guidance recommends testing and labeling for 510(k) submissions for devices that include antimicrobial agents. It is intended as a supplement to other device-specific guidance issued by the Center for Devices and Radiological Health (CDRH). Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comments on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance by October 17, 2007. DATES: Submit written requests for single copies of the draft guidance document entitled ‘‘Premarket Notification (510(k)) Submissions for Medical Devices That Include Antimicrobial Agents’’ to the Division of Small Manufacturers, International, and Consumer Assistance (HFZ–220), Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 240–276– 3151. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written comments concerning this draft guidance 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.fda.gov/dockets/ecomments. Identify comments with the docket number found in brackets in the heading of this document. ADDRESSES: FOR FURTHER INFORMATION CONTACT: Michelle Rios, Center for Devices and Radiological Health (HFZ–480), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240–276–3747. SUPPLEMENTARY INFORMATION: I. Background In recent years there has been increased interest in adding antimicrobial agents to medical devices for specific or limited indications for use, such as reduction or prevention of a device-related infection, or reduction or inhibition of colonization of a medical device. FDA developed this draft guidance to assist device manufacturers in preparing premarket notification (510(k)) submissions for medical devices that include antimicrobial agents. E:\FR\FM\19JYN1.SGM 19JYN1

Agencies

[Federal Register Volume 72, Number 138 (Thursday, July 19, 2007)]
[Notices]
[Pages 39629-39630]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-13950]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007P-0052]


Determination That Brethine (Terbutaline Sulfate) Injection 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 Brethine (Terbutaline Sulfate) Injection was not 
withdrawn from sale for reasons of safety or effectiveness. This 
determination will allow FDA to approve abbreviated new drug 
applications (ANDAs) for terbutaline sulfate injection if all other 
legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Carol E. Drew, Center for Drug 
Evaluation and Research (HFD-7), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-2041.

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 under a new drug 
application (NDA). ANDA applicants do not have to repeat the extensive 
clinical testing otherwise necessary to gain approval of an 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

[[Page 39630]]

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 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). Regulations also provide that the 
agency must make a determination as to 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 (Sec.  
314.161(a)(1) (21 CFR 314.161(a)(1))). FDA may not approve an ANDA that 
does not refer to a listed drug.
    On February 9, 2007, West-ward Pharmaceutical Corp. (West-ward), on 
behalf of Hikma Farmaceutica (Portugal), S.A., submitted a citizen 
petition (Docket No. 2007P-0052/CP1) to FDA under 21 CFR 10.30. The 
petition requests that the agency determine whether Brethine 
(terbutaline sulfate) injection (NDA 18-571), manufactured by 
AaiPharma, was withdrawn from sale for reasons of safety or 
effectiveness. AaiPharma ceased manufacture of Brethine injection and 
it was moved from the prescription drug product list to the 
``Discontinued Drug Product List'' section of the Orange Book in August 
of 2006.
    Brethine injection was first approved in 1981; this approval was 
for a glass ampoule container closure system. In 2004 AaiPharma 
received approval of a glass vial container closure system for a 
Brethine injection formulation that contained 0.055 percent disodium 
edetate. When Brethine injection was discontinued, an approved generic 
was chosen as the replacement reference listed drug. The replacement 
reference listed drug does not contain 0.055 disodium edetate and is 
based on the original glass ampoule formulation. Therefore, West-ward 
requests that the agency make a determination that the reformulated 
version of Brethine injection was not withdrawn for safety or efficacy 
reasons.
    FDA has reviewed its records and, under Sec.  314.161, has 
determined that Brethine (terbutaline sulfate) injection was not 
withdrawn from sale for reasons of safety or effectiveness. The 
petitioner identified no data or other information suggesting that 
Brethine containing 0.055 disodium edetate 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. Furthermore 
we have determined that the change in formulation was not for safety or 
efficacy reasons. Our files indicate that disodium edetate was added as 
a protectant against certain oxidation-derived terbutaline impurities 
and degradants when the manufacturing site and container closure system 
were changed. Accordingly, the agency will continue to list terbutaline 
sulfate injection 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 terbutaline sulfate injection 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: July 12, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-13950 Filed 7-18-07; 8:45 am]
BILLING CODE 4160-01-S

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