Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations; Availability, 18561-18562 [2014-07330]

Download as PDF Federal Register / Vol. 79, No. 63 / Wednesday, April 2, 2014 / Notices tkelley on DSK3SPTVN1PROD with NOTICES February 2012, Barr Pharmaceuticals added the following statement to the labeling directing health care professionals to transfer the capsule contents to a syringe that cannot accept a needle: ‘‘A parenteral syringe can be used to extract the liquid inside the capsule, but the liquid should always be transferred to a syringe that cannot accept a needle and that is designed for administration orally or via a nasogastric tube or PEG.’’ 6 Despite these efforts by FDA and the drug’s sponsor, a small number of adverse events due to erroneous intravenous administration continue to be reported to the Agency. Nevertheless, FDA believes that it is in the best interest of the public health for patients to continue to have access to this lifesaving drug for a number of reasons. First, only a portion of the patients treated with nimodipine capsules are unconscious and unable to swallow— these are the patients who are most vulnerable to the medication errors identified. Of those patients that begin their course of treatment (two capsules every 4 hours for 21 days) while unable to swallow, many improve to the point where they are awake and able to swallow a capsule soon after treatment begins. Hence, for many patients, the risk of erroneous intravenous administration is only present during a small percentage of their overall duration of treatment. Second, we believe the approval of a nimodipine oral solution 7 that is administered via an oral syringe only will further prevent erroneous intravenous administration because it can be used for those patients who are unconscious or unable to swallow and eliminates the need for use of a parenteral syringe, which is the source of the medication errors. And third, we believe the capsules play an important role in treating patients with subarachnoid hemorrhage because many are discharged from the hospital while taking capsules, and capsules provide a more convenient route of administration that increases patient compliance. As a result, we believe that the benefits of having nimodipine capsules on the market to treat these extremely sick patients, who could die or have serious permanent injury without PostmarketDrugSafetyInformationforPatientsand Providers/ucm220386.htm. 6 As used here, PEG refers to a percutaneous endoscopic gastrostomy tube. 7 Nymalize was approved on May 10, 2013. See FDA’s News Release, ‘‘FDA Approves Nymalize— First Nimodipine Oral Solution for Use in Certain Brain Hemorrhage Patients,’’ available at https:// www.fda.gov/NewsEvents/Newsroom/Press Announcements/ucm352280.htm. VerDate Mar<15>2010 17:01 Apr 01, 2014 Jkt 232001 treatment, outweigh the risks of medication errors. Therefore, after considering the Petition and reviewing Agency records, and based on the information we have at this time, FDA has determined under § 314.161 that NIMOTOP (nimodipine) Capsules, 30 mg, was not withdrawn for reasons of safety or effectiveness. Accordingly, the Agency will continue to list NIMOTOP (Nimodipine) Capsules, 30 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 ANDAs that refer to NIMOTOP (Nimodipine) Capsules, 30 mg. Additional ANDAs that refer to NIMOTOP (Nimodipine) Capsules, 30 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: March 27, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–07332 Filed 4–1–14; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2007–D–0369] Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of additional draft and revised draft product-specific bioequivalence (BE) recommendations. The recommendations provide productspecific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled ‘‘Guidance for Industry on Bioequivalence Recommendations for Specific Products; SUMMARY: PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 18561 Availability,’’ which explained the process that would be used to make product-specific BE recommendations available to the public on FDA’s Web site. The BE recommendations identified in this notice were developed using the process described in that guidance. 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 comments on these draft and revised draft guidances before it begins work on the final versions of the guidances, submit either electronic or written comments on the draft and revised draft product-specific BE recommendations listed in this notice by June 2, 2014. ADDRESSES: Submit written requests for single copies of the individual BE guidances 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 selfaddressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance recommendations. Submit electronic comments on the draft product-specific BE recommendations 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. FOR FURTHER INFORMATION CONTACT: Kris ´ Andre, Center for Drug Evaluation and Research (HFD–600), Food and Drug Administration, 7520 Standish Pl., Rockville, MD 20855, 240–276–8866. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the availability of a guidance for industry entitled ‘‘Guidance for Industry on Bioequivalence Recommendations for Specific Products; Availability,’’ which explained the process that would be used to make product-specific BE recommendations available to the public on FDA’s Web site at https:// www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm. As described in that guidance, FDA adopted this process as a means to develop and disseminate productspecific BE recommendations and provide a meaningful opportunity for the public to consider and comment on those recommendations. Under that E:\FR\FM\02APN1.SGM 02APN1 18562 Federal Register / Vol. 79, No. 63 / Wednesday, April 2, 2014 / Notices process, draft recommendations are posted on FDA’s Web site and announced periodically in the Federal Register. The public is encouraged to submit comments on those recommendations within 60 days of their announcement in the Federal Register. FDA considers any comments received, and either publishes final recommendations or publishes revised draft recommendations for comment. Recommendations were last announced in the Federal Register on November 6, 2013 (78 FR 66745). This notice announces draft product-specific recommendations, either new or revised, that are posted on FDA’s Web site. II. Drug Products for Which New Draft Product-Specific BE Recommendations Are Available FDA is announcing the availability of a new draft guidance for industry on product-specific BE recommendations for drug products containing the following active ingredients: TABLE 2—REVISED DRAFT PRODUCT- ComplianceRegulatoryInformation/ SPECIFIC BE RECOMMENDATIONS Guidances/default.htm or https:// www.regulations.gov. FOR DRUG PRODUCTS A ..... B ..... D ..... I ....... L ...... M ..... N ..... O ..... T ..... Abiraterone acetate. Amlodipine besylate; Benazepril hydrochloride. Brimonidine tartrate (multiple reference listed drugs). Doxycycline hyclate. Dronabinol. Dutasteride; Tamsulosin hydrochloride. Icosapent Ethyl. Leuprolide acetate (multiple reference listed drugs and strengths). Metoprolol succinate. Morphine sulfate. Mycophenolate mofetil (multiple reference listed drugs and dosage forms). Mycophenolic acid. Naltrexone. Octreotide acetate. Trimethoprim. Triptorelin pamoate For a complete history of previously published Federal Register notices related to product-specific BE TABLE 1—NEW DRAFT PRODUCT-SPE- recommendations, please go to https:// www.regulations.gov and enter Docket CIFIC BE RECOMMENDATIONS FOR No. FDA–2007–D–0369. DRUG PRODUCTS These draft and revised draft guidances are being issued consistent A ..... Amphotericin B. with FDA’s good guidance practices Atorvastatin calcium; Ezetimibe. regulation (21 CFR 10.115). These Axitinib. guidances represent the Agency’s B ..... Brinzolamide. current thinking on product-specific Buprenorphine. design of BE studies to support ANDAs. Buprenorphine hydrochloride. Buprenorphine hydrochloride; They do not create or confer any rights for or on any person and do not operate Naloxone hydrochloride. C ..... Clobazam. to bind FDA or the public. An D ..... Desoximetasone (multiple reference alternative approach may be used if listed drugs and dosage forms). such approach satisfies the Diazoxide. requirements of the applicable statutes E ..... Erythromycin. and regulations. Estradiol. F ..... G ..... H ..... L ...... M ..... P ..... R ..... T ..... tkelley on DSK3SPTVN1PROD with NOTICES V ..... Fentanyl citrate. Guaifenesin. Hydrochlorothiazide; Metoprolol succinate. Levonorgestrel (multiple reference listed drugs). Linagliptin; Metformin hydrochloride. Mesalamine. Perampanel. Pindolol. Prednisolone acetate. Rabeprazole sodium. Teriflunomide. Tranylcypromine sulfate. Verteporfin. III. Drug Products for Which Revised Draft Product-Specific BE Recommendations Are Available FDA is announcing the availability of a revised draft guidance for industry on product-specific BE recommendations for drug products containing the following active ingredients: VerDate Mar<15>2010 17:01 Apr 01, 2014 Jkt 232001 IV. Comments Interested persons may submit either electronic comments on any of the specific BE recommendations posted on FDA’s Web site to https:// www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessaary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. The guidances, notices, and received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https:// www.regulations.gov. V. Electronic Access Persons with access to the Internet may obtain the document at either https://www.fda.gov/Drugs/Guidance PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 Dated: March 27, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–07330 Filed 4–1–14; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–0337] Standards for the Interoperable Exchange of Information for Tracing of Human, Finished, Prescription Drugs, in Paper or Electronic Format; Public Workshop; Request for Comments AGENCY: Food and Drug Administration, HHS. Notice of public workshop; request for comments. ACTION: The Food and Drug Administration (FDA) is announcing a public workshop entitled ‘‘Standards for the Interoperable Exchange of Information for Tracing of Human, Finished, Prescription Drugs, in Paper or Electronic Format.’’ This public workshop will provide a forum for discussing the development of these standards in the Drug Supply Chain Security Act of 2013. In particular, participants will be asked to provide information, current practices, research, and ideas on the interoperable exchange of transaction information, transaction history, and transaction statements, in paper or electronic format, for each transfer of drug product in which a change of ownership occurs. This public workshop will also provide a forum to discuss the feasibility of establishing standardized documentation to be used by members of the pharmaceutical distribution supply chain to convey this information to the subsequent purchaser of a drug product and to facilitate the exchange of lot level data. As FDA continues to work on developing standards for interoperable exchange, the Agency is seeking public input to ensure that we consider information regarding all drug supply chain stakeholders. DATES: The public workshop will be held on May 8 and 9, 2014, from 9 a.m. to 5 p.m. ADDRESSES: The public workshop will be held at FDA’s White Oak Campus, 10903 New Hampshire Ave. Bldg. 31 Conference Center, the Great Room (rm. 1503A), Silver Spring, MD 20993. Entrance for the public meeting E:\FR\FM\02APN1.SGM 02APN1

Agencies

[Federal Register Volume 79, Number 63 (Wednesday, April 2, 2014)]
[Notices]
[Pages 18561-18562]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-07330]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0369]


Draft and Revised Draft Guidances for Industry Describing 
Product-Specific Bioequivalence Recommendations; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of additional draft and revised draft product-specific 
bioequivalence (BE) recommendations. The recommendations provide 
product-specific guidance on the design of BE studies to support 
abbreviated new drug applications (ANDAs). In the Federal Register of 
June 11, 2010, FDA announced the availability of a guidance for 
industry entitled ``Guidance for Industry on Bioequivalence 
Recommendations for Specific Products; Availability,'' which explained 
the process that would be used to make product-specific BE 
recommendations available to the public on FDA's Web site. The BE 
recommendations identified in this notice were developed using the 
process described in that guidance.

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 comments on 
these draft and revised draft guidances before it begins work on the 
final versions of the guidances, submit either electronic or written 
comments on the draft and revised draft product-specific BE 
recommendations listed in this notice by June 2, 2014.

ADDRESSES: Submit written requests for single copies of the individual 
BE guidances 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 recommendations.
    Submit electronic comments on the draft product-specific BE 
recommendations 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.

FOR FURTHER INFORMATION CONTACT: Kris Andr[eacute], Center for Drug 
Evaluation and Research (HFD-600), Food and Drug Administration, 7520 
Standish Pl., Rockville, MD 20855, 240-276-8866.

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of June 11, 2010 (75 FR 33311), FDA 
announced the availability of a guidance for industry entitled 
``Guidance for Industry on Bioequivalence Recommendations for Specific 
Products; Availability,'' which explained the process that would be 
used to make product-specific BE recommendations available to the 
public on FDA's Web site at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.
    As described in that guidance, FDA adopted this process as a means 
to develop and disseminate product-specific BE recommendations and 
provide a meaningful opportunity for the public to consider and comment 
on those recommendations. Under that

[[Page 18562]]

process, draft recommendations are posted on FDA's Web site and 
announced periodically in the Federal Register. The public is 
encouraged to submit comments on those recommendations within 60 days 
of their announcement in the Federal Register. FDA considers any 
comments received, and either publishes final recommendations or 
publishes revised draft recommendations for comment. Recommendations 
were last announced in the Federal Register on November 6, 2013 (78 FR 
66745). This notice announces draft product-specific recommendations, 
either new or revised, that are posted on FDA's Web site.

II. Drug Products for Which New Draft Product-Specific BE 
Recommendations Are Available

    FDA is announcing the availability of a new draft guidance for 
industry on product-specific BE recommendations for drug products 
containing the following active ingredients:

Table 1--New Draft Product-Specific BE Recommendations for Drug Products
------------------------------------------------------------------------
 
------------------------------------------------------------------------
A..............................  Amphotericin B.
                                 Atorvastatin calcium; Ezetimibe.
                                 Axitinib.
B..............................  Brinzolamide.
                                 Buprenorphine.
                                 Buprenorphine hydrochloride.
                                 Buprenorphine hydrochloride; Naloxone
                                  hydrochloride.
C..............................  Clobazam.
D..............................  Desoximetasone (multiple reference
                                  listed drugs and dosage forms).
                                 Diazoxide.
E..............................  Erythromycin.
                                 Estradiol.
F..............................  Fentanyl citrate.
G..............................  Guaifenesin.
H..............................  Hydrochlorothiazide; Metoprolol
                                  succinate.
L..............................  Levonorgestrel (multiple reference
                                  listed drugs).
                                 Linagliptin; Metformin hydrochloride.
M..............................  Mesalamine.
P..............................  Perampanel.
                                 Pindolol.
                                 Prednisolone acetate.
R..............................  Rabeprazole sodium.
T..............................  Teriflunomide.
                                 Tranylcypromine sulfate.
V..............................  Verteporfin.
------------------------------------------------------------------------

III. Drug Products for Which Revised Draft Product-Specific BE 
Recommendations Are Available

    FDA is announcing the availability of a revised draft guidance for 
industry on product-specific BE recommendations for drug products 
containing the following active ingredients:

   Table 2--Revised Draft Product-Specific BE Recommendations for Drug
                                Products
------------------------------------------------------------------------
 
------------------------------------------------------------------------
A..............................  Abiraterone acetate.
                                 Amlodipine besylate; Benazepril
                                  hydrochloride.
B..............................  Brimonidine tartrate (multiple
                                  reference listed drugs).
D..............................  Doxycycline hyclate.
                                 Dronabinol.
                                 Dutasteride; Tamsulosin hydrochloride.
I..............................  Icosapent Ethyl.
L..............................  Leuprolide acetate (multiple reference
                                  listed drugs and strengths).
M..............................  Metoprolol succinate.
                                 Morphine sulfate.
                                 Mycophenolate mofetil (multiple
                                  reference listed drugs and dosage
                                  forms).
                                 Mycophenolic acid.
N..............................  Naltrexone.
O..............................  Octreotide acetate.
T..............................  Trimethoprim.
                                 Triptorelin pamoate
------------------------------------------------------------------------

    For a complete history of previously published Federal Register 
notices related to product-specific BE recommendations, please go to 
https://www.regulations.gov and enter Docket No. FDA-2007-D-0369.
    These draft and revised draft guidances are being issued consistent 
with FDA's good guidance practices regulation (21 CFR 10.115). These 
guidances represent the Agency's current thinking on product-specific 
design of BE studies to support ANDAs. They do not create or confer any 
rights for or on any person and do 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.

IV. Comments

    Interested persons may submit either electronic comments on any of 
the specific BE recommendations posted on FDA's Web site to https://www.regulations.gov or written comments to the Division of Dockets 
Management (see ADDRESSES). It is only necessaary to send one set of 
comments. Identify comments with the docket number found in brackets in 
the heading of this document. The guidances, notices, and received 
comments may be seen in the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday, and will be posted to the 
docket at https://www.regulations.gov.

V. Electronic Access

    Persons with access to the Internet may obtain the document at 
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.

    Dated: March 27, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-07330 Filed 4-1-14; 8:45 am]
BILLING CODE 4160-01-P
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