Determination That REYATAZ (Atazanavir Sulfate) Capsules, 100 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 509-510 [2014-30909]

Download as PDF 509 Federal Register / Vol. 80, No. 3 / Tuesday, January 6, 2015 / Notices FDA also provides recommendations on how to prioritize reporting when regulatory timelines cannot be met due to limited resources during a pandemic, so that FDA continues to receive critical safety information in a timely manner. For example, table 1 of the guidance outlines how companies should prioritize their submission of postmarketing safety reports during an influenza pandemic if normal processes of mandatory adverse event reporting are not feasible because of high employee absenteeism: Reports for pandemic influenza vaccines, drugs and biological products labeled for the treatment of influenza, drugs and biologics approved for less than three years, and products with special concerns as specified by FDA. The list includes reporting on newly approved products as the comment recommended. The guidance provides resources for companies establishing a COOP plan, but specifying the content of the COOP plans as suggested by the comment is beyond the scope of the guidance. Instead, the guidance provides the more general recommendation that ‘‘each firm’s pandemic influenza COOP plan should include instructions for reporting adverse events and the submission of any stored reports not submitted in the regulatory timeframes’’ (see section III.B, page 2). FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Type of reporting Number of respondents Number of responses per respondent Total annual responses Average burden per response Total hours Notify FDA when normal reporting is not feasible ............... 500 1 500 8 4,000 Average burden per recordkeeper Total hours 1 There are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Number of recordkeepers Type of recordkeeping Number of records per recordkeeper Total annual records Add adverse event reporting plan to COOP ....................... Maintain documentation of influenza pandemic conditions and resultant high absenteeism ....................................... Maintain records to identify what reports have been stored and when the reporting process was restored ................ 5,000 1 5,000 50 250,000 500 1 500 8 4,000 500 1 500 8 4,000 Total .............................................................................. ........................ ........................ ........................ ........................ 258,000 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: December 30, 2014. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2014–30907 Filed 1–5–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–P–0980] Determination That REYATAZ (Atazanavir Sulfate) Capsules, 100 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. tkelley on DSK3SPTVN1PROD with NOTICES ACTION: Notice. The Food and Drug Administration (FDA or Agency) has determined that REYATAZ (atazanavir sulfate) capsules, 100 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug SUMMARY: VerDate Sep<11>2014 19:38 Jan 05, 2015 Jkt 235001 applications (ANDAs) for atazanavir sulfate, 100 mg, if all other legal and regulatory requirements are met. FOR FURTHER INFORMATION CONTACT: Na’Im R. Moses, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6224, Silver Spring, MD 20993–0002, 240– 402–3990. SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98–417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products 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 1984 amendments include what is now section 505(j)(7) of the Federal PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 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). A person may petition the Agency to determine, or the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness. This determination may be made at any time after the drug has been withdrawn from sale, but must be made prior to approving an ANDA that refers to the listed drug (§ 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does not refer to a listed drug. REYATAZ (atazanavir sulfate) capsules, 100 mg, is the subject of NDA 21–567, held by Bristol-Myers Squibb, and initially approved on June 20, 2003. E:\FR\FM\06JAN1.SGM 06JAN1 tkelley on DSK3SPTVN1PROD with NOTICES 510 Federal Register / Vol. 80, No. 3 / Tuesday, January 6, 2015 / Notices REYATAZ is a protease inhibitor indicated for use in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV–1) infection in patients 3 months and older weighing at least 10 kilograms. In a letter dated August 19, 2014, Bristol-Myers Squibb notified FDA that REYATAZ (atazanavir sulfate) capsules, 100 mg, had been discontinued. The REYATAZ 150-, 200-, and 300-mg capsule strengths continue to be marketed by Bristol-Myers Squibb. The 100-mg dosage strength of this drug product is currently listed in the ‘‘Discontinued Drug Product List’’ section of the Orange Book. Lachman Consultant Services, Inc., submitted a citizen petition dated July 7, 2014 (Docket No. FDA–2014–P– 0980), under 21 CFR 10.30, requesting that the Agency determine whether REYATAZ (atazanavir sulfate) capsules, 100 mg, were withdrawn from sale for reasons of safety or effectiveness. After considering the citizen petition and reviewing Agency records and based on the information we have at this time, FDA has determined under § 314.161 that REYATAZ (atazanavir sulfate) capsules, 100 mg, were not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that REYATAZ (atazanavir sulfate) capsules, 100 mg, were withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of REYATAZ (atazanavir sulfate) capsules, 100 mg, from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. We have reviewed the available evidence and determined that the product was not withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list REYATAZ (atazanavir sulfate) capsules, 100 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. ANDAs that refer to REYATAZ (atazanavir sulfate) capsules, 100 mg, may 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 VerDate Sep<11>2014 19:38 Jan 05, 2015 Jkt 235001 advise ANDA applicants to submit such labeling. Dated: December 30, 2014. Leslie Kux, Associate Commissioner for Policy. 6011 Executive Boulevard, Suite 325, Rockville, MD 20852–3804; Telephone: (301) 435–5282; Facsimile: (301) 435– 4013; Email: Eggerton.Campbell@nih.gov. [FR Doc. 2014–30909 Filed 1–5–15; 8:45 am] SUPPLEMENTARY INFORMATION: BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive License: Her2 Monoclonal Antibodies, Antibody Drug Conjugates, and Site Specific Antibody Conjugate Methods for the Treatment of Cancer AGENCY: National Institutes of Health, HHS. ACTION: Notice. This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to HUIYU Pharmaceuticals Co, Ltd located in Neijiang City, CHINA to practice the inventions embodied in U.S. Provisional Patent Application 61/833,732, filed June 11, 2013 entitled ‘‘Her2-Specific Monoclonal Antibodies and Conjugates Thereof’’ [HHS Ref. No.: E–351–2013/0– US–01], and International Application PCT/US2014/041492, filed June 9, 2014 entitled ‘‘Her2-Specific Monoclonal Antibodies and Conjugates Thereof’’ [HHS Ref. No.: E–351–2013/0–PCT–02], any PCT, US or foreign applications claiming the benefit of. The patent rights in these inventions have been assigned to the Government of the United States of America. The prospective exclusive license territory may be limited to China, and the field of use may be limited to: SUMMARY: The use of the m860 monoclonal antibodies as mono-specific antibodies; or targeting moieties for immunoconjugates, wherein the antibodies are conjugated to auristatin F and analogues thereof, for the treatment of HER2 positive cancers. Only written comments or applications for a license (or both) which are received by the NIH Office of Technology Transfer on or before February 5, 2015 will be considered. ADDRESSES: Requests for copies of the patent application, inquiries, comments, and other materials relating to the contemplated exclusive license should be directed to: Eggerton Campbell, Ph.D. Licensing and Patenting Manager, Cancer Branch, Office of Technology Transfer, National Institutes of Health, DATES: PO 00000 Frm 00030 Fmt 4703 Sfmt 9990 These inventions concern Antibody Drug Conjugates (ADCs). ADCs can demonstrate high efficacy as cancer therapeutics, however, much more can be done to improve their efficacy and safety profile. Site-specific antibody drug conjugation is a promising way to do this. The scientists at the NIH have identified a fully human monoclonal antibody, m860, that binds to cell surface-associated Her2 with affinity comparable to that of Trastuzumab (Herceptin) but to a different epitope. In addition, the scientist developed a sitespecific glycan engineering method to conjugate the antibody to the small molecule drug auristatin F. The ADC prepared though this site-specific approach shows very good stability, cell surface binding activity and also potent specific cell killing activity against Her2 positive cancer cells, including Trastuzumab resistant breast cancer cells. This ADC has the potential to be developed as a targeted therapeutic for Her2-overexpressing cancers. The prospective exclusive license will be royalty bearing and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR part 404. The prospective exclusive license may be granted unless the NIH receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR part 404 within thirty (30) days from the date of this published notice. Applications for a license in the field of use that are filed in response to this notice will be treated as objections to the grant of the contemplated exclusive license. Comments and objections submitted to this notice will not be made available for public inspection and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552. Dated: December 30, 2014. Richard U. Rodriguez, Acting Director, Office of Technology Transfer, National Institutes of Health. [FR Doc. 2014–30878 Filed 1–5–15; 8:45 am] BILLING CODE 4140–01–P E:\FR\FM\06JAN1.SGM 06JAN1

Agencies

[Federal Register Volume 80, Number 3 (Tuesday, January 6, 2015)]
[Notices]
[Pages 509-510]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-30909]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-P-0980]


Determination That REYATAZ (Atazanavir Sulfate) Capsules, 100 
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 or Agency) has 
determined that REYATAZ (atazanavir sulfate) capsules, 100 milligrams 
(mg), were not withdrawn from sale for reasons of safety or 
effectiveness. This determination will allow FDA to approve abbreviated 
new drug applications (ANDAs) for atazanavir sulfate, 100 mg, if all 
other legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Na'Im R. Moses, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6224, Silver Spring, MD 20993-0002, 240-
402-3990.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price 
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) 
(the 1984 amendments), which authorized the approval of duplicate 
versions of drug products 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 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).
    A person may petition the Agency to determine, or the Agency may 
determine on its own initiative, whether a listed drug was withdrawn 
from sale for reasons of safety or effectiveness. This determination 
may be made at any time after the drug has been withdrawn from sale, 
but must be made prior to approving an ANDA that refers to the listed 
drug (Sec.  314.161 (21 CFR 314.161)). FDA may not approve an ANDA that 
does not refer to a listed drug.
    REYATAZ (atazanavir sulfate) capsules, 100 mg, is the subject of 
NDA 21-567, held by Bristol-Myers Squibb, and initially approved on 
June 20, 2003.

[[Page 510]]

REYATAZ is a protease inhibitor indicated for use in combination with 
other antiretroviral agents for the treatment of human immunodeficiency 
virus (HIV-1) infection in patients 3 months and older weighing at 
least 10 kilograms.
    In a letter dated August 19, 2014, Bristol-Myers Squibb notified 
FDA that REYATAZ (atazanavir sulfate) capsules, 100 mg, had been 
discontinued. The REYATAZ 150-, 200-, and 300-mg capsule strengths 
continue to be marketed by Bristol-Myers Squibb. The 100-mg dosage 
strength of this drug product is currently listed in the ``Discontinued 
Drug Product List'' section of the Orange Book.
    Lachman Consultant Services, Inc., submitted a citizen petition 
dated July 7, 2014 (Docket No. FDA-2014-P-0980), under 21 CFR 10.30, 
requesting that the Agency determine whether REYATAZ (atazanavir 
sulfate) capsules, 100 mg, were withdrawn from sale for reasons of 
safety or effectiveness.
    After considering the citizen petition and reviewing Agency records 
and based on the information we have at this time, FDA has determined 
under Sec.  314.161 that REYATAZ (atazanavir sulfate) capsules, 100 mg, 
were not withdrawn for reasons of safety or effectiveness. The 
petitioner has identified no data or other information suggesting that 
REYATAZ (atazanavir sulfate) capsules, 100 mg, were withdrawn for 
reasons of safety or effectiveness. We have carefully reviewed our 
files for records concerning the withdrawal of REYATAZ (atazanavir 
sulfate) capsules, 100 mg, from sale. We have also independently 
evaluated relevant literature and data for possible postmarketing 
adverse events. We have reviewed the available evidence and determined 
that the product was not withdrawn from sale for reasons of safety or 
effectiveness.
    Accordingly, the Agency will continue to list REYATAZ (atazanavir 
sulfate) capsules, 100 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. ANDAs that refer to REYATAZ (atazanavir sulfate) 
capsules, 100 mg, may 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: December 30, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-30909 Filed 1-5-15; 8:45 am]
BILLING CODE 4164-01-P

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