80 FR 80775 - Determination That KYTRIL (Granisetron Hydrochloride) Tablets, Equivalent 1 Milligram and 2 Milligram Base, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 248 (December 28, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 248 (December 28, 2015)
| Page Range | 80775-80776 | |
| FR Document | 2015-32496 |
[Federal Register Volume 80, Number 248 (Monday, December 28, 2015)] [Notices] [Pages 80775-80776] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-32496] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-P-1898] Determination That KYTRIL (Granisetron Hydrochloride) Tablets, Equivalent 1 Milligram and 2 Milligram Base, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS.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determined that KYTRIL (granisetron hydrochloride) tablets, equivalent (EQ) 1 milligram (mg) and 2 mg base, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for KYTRIL (granisetron hydrochloride) tablets, EQ 1 mg and 2 mg base, if all other legal and regulatory requirements are met. FOR FURTHER INFORMATION CONTACT: Daniel Orr, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6246, Silver Spring, MD 20993-0002, 240-402-0979. 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 [[Page 80776]] 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. KYTRIL (granisetron hydrochloride) tablets, EQ 1 mg and 2 mg base, are the subject of NDA 020305, held by Hoffmann-La Roche, Inc., and initially approved on March 16, 1995. KYTRIL is indicated for the prevention of nausea and/or vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin, and for the prevention and treatment of postoperative nausea and vomiting in adults. On April 30, 2012, Hoffman-La Roche notified FDA that KYTRIL (granisteron hydrochloride) tablets, EQ 1 mg and 2 mg base, were being discontinued, and FDA moved the drug products to the ``Discontinued Drug Product List'' section of the Orange Book. Kurt R. Karst, on behalf of Hyman, Phelps & McNamara, P.C., submitted a citizen petition dated May 27, 2015 (Docket No. FDA-2015-P- 1898), under 21 CFR 10.30, requesting that the Agency determine whether KYTRIL (granisteron hydrochloride) tablets, EQ 1 mg and 2 mg base, 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 KYTRIL (granisteron hydrochloride) tablets, EQ 1 mg and 2 mg base, were not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that KYTRIL (granisteron hydrochloride) tablets, EQ 1 mg and 2 mg base, were withdrawn for reasons of safety or effectiveness We have carefully reviewed our files for records concerning the withdrawal of KYTRIL (granisteron hydrochloride) tablets, EQ 1 mg and 2 mg base, 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 products were not withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list KYTRIL (granisteron hydrochloride) tablets, EQ 1 mg and 2 mg base, 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 KYTRIL (granisteron hydrochloride) tablets, EQ 1 mg and 2 mg base, 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 21, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-32496 Filed 12-24-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 248 / Monday, December 28, 2015 / Notices 80775
so long as the patented item (human approval phase. These periods of time Dated: December 21, 2015.
drug product, animal drug product, were derived from the following dates: Leslie Kux,
medical device, food additive, or color 1. The date an exemption under Associate Commissioner for Policy.
additive) was subject to regulatory section 505(i) of the Federal Food, Drug, [FR Doc. 2015–32475 Filed 12–24–15; 8:45 am]
review by FDA before the item was and Cosmetic Act (21 U.S.C. 355(i)) BILLING CODE 4164–01–P
marketed. Under these acts, a product’s became effective: January 18, 2006. FDA
regulatory review period forms the basis has verified the applicant’s claim that
for determining the amount of extension the date the investigational new drug DEPARTMENT OF HEALTH AND
an applicant may receive. HUMAN SERVICES
application became effective was on
A regulatory review period consists of
two periods of time: A testing phase and January 18, 2006.
Food and Drug Administration
an approval phase. For human 2. The date the application was
biological products, the testing phase initially submitted with respect to the [Docket No. FDA–2015–P–1898]
begins when the exemption to permit human biological product under section
Determination That KYTRIL
the clinical investigations of the 351 of the Public Health Service Act (42
(Granisetron Hydrochloride) Tablets,
biological becomes effective and runs U.S.C. 262): August 27, 2012. The
Equivalent 1 Milligram and 2 Milligram
until the approval phase begins. The applicant claims August 24, 2012, as the
Base, Were Not Withdrawn From Sale
approval phase starts with the initial date the biologics license application
for Reasons of Safety or Effectiveness
submission of an application to market (BLA) for KADCYLA (BLA 125427) was
the human biological product and initially submitted. However, FDA AGENCY: Food and Drug Administration,
continues until FDA grants permission records indicate that BLA 125427 was HHS.
to market the biological product. submitted on August 27, 2012. ACTION: Notice.
Although only a portion of a regulatory 3. The date the application was
review period may count toward the approved: February 22, 2013. FDA has SUMMARY: The Food and Drug
actual amount of extension that the Administration (FDA or Agency) has
verified the applicant’s claim that BLA
Director of USPTO may award (for determined that KYTRIL (granisetron
125427 was approved on February 22,
example, half the testing phase must be hydrochloride) tablets, equivalent (EQ)
2013.
subtracted as well as any time that may 1 milligram (mg) and 2 mg base, were
have occurred before the patent was This determination of the regulatory not withdrawn from sale for reasons of
issued), FDA’s determination of the review period establishes the maximum safety or effectiveness. This
length of a regulatory review period for potential length of a patent extension. determination will allow FDA to
a human biological product will include However, the USPTO applies several approve abbreviated new drug
all of the testing phase and approval statutory limitations in its calculations applications (ANDAs) for KYTRIL
phase as specified in 35 U.S.C. of the actual period for patent extension. (granisetron hydrochloride) tablets, EQ
156(g)(1)(B). In its applications for patent extension, 1 mg and 2 mg base, if all other legal
FDA has approved for marketing the this applicant seeks 1,277 or 60 days of and regulatory requirements are met.
human biologic product KADCYLA patent term extension. FOR FURTHER INFORMATION CONTACT:
(ado-trastuzumab emtansine).
III. Petitions Daniel Orr, Center for Drug Evaluation
KADCYLA is indicated as a single agent,
and Research, Food and Drug
for the treatment of patients with HER2- Anyone with knowledge that any of Administration, 10903 New Hampshire
positive metastatic breast cancer who the dates as published are incorrect may Ave., Bldg. 51, Rm. 6246, Silver Spring,
previously received trastuzumab and a submit either electronic or written
taxane, separately or in combination. MD 20993–0002, 240–402–0979.
comments and ask for a redetermination SUPPLEMENTARY INFORMATION: In 1984,
Subsequent to this approval, the USPTO (see DATES). Furthermore, any interested
received patent term restoration Congress enacted the Drug Price
person may petition FDA for a Competition and Patent Term
applications for KADCYLA (U.S. Patent
determination regarding whether the Restoration Act of 1984 (Pub. L. 98–417)
Nos. 7,097,840 and 8,337,856) from
applicant for extension acted with due (the 1984 amendments), which
Genentech, Inc., and the USPTO
diligence during the regulatory review authorized the approval of duplicate
requested FDA’s assistance in
period. To meet its burden, the petition versions of drug products under an
determining these patents’ eligibility for
must be timely (see DATES) and contain ANDA procedure. ANDA applicants
patent term restoration. In a letter dated
sufficient facts to merit an FDA must, with certain exceptions, show that
May 23, 2014, FDA advised the USPTO
investigation. (See H. Rept. 857, part 1, the drug for which they are seeking
that this human biological product had
98th Cong., 2d sess., pp. 41–42, 1984.) approval contains the same active
undergone a regulatory review period
Petitions should be in the format ingredient in the same strength and
and that the approval of KADCYLA
specified in 21 CFR 10.30. dosage form as the listed drug, which is
represented the first permitted
commercial marketing or use of the Submit petitions electronically to a version of the drug that was
product. Thereafter, the USPTO http://www.regulations.gov at Docket previously approved. ANDA applicants
requested that FDA determine the No. FDA–2013–S–0610. Submit written do not have to repeat the extensive
product’s regulatory review period. petitions (two copies are required) to the clinical testing otherwise necessary to
Division of Dockets Management (HFA– gain approval of a new drug application
II. Determination of Regulatory Review
mstockstill on DSK4VPTVN1PROD with NOTICES
305), Food and Drug Administration, (NDA).
Period 5630 Fishers Lane, Rm. 1061, Rockville, The 1984 amendments include what
FDA has determined that the MD 20852. Petitions that have not been is now section 505(j)(7) of the Federal
applicable regulatory review period for made publicly available on http:// Food, Drug, and Cosmetic Act (21 U.S.C.
KADCYLA is 2,594 days. Of this time, www.regulations.gov may be viewed in 355(j)(7)), which requires FDA to
2,414 days occurred during the testing the Division of Dockets Management publish a list of all approved drugs.
phase of the regulatory review period, between 9 a.m. and 4 p.m., Monday FDA publishes this list as part of the
while 180 days occurred during the through Friday. ‘‘Approved Drug Products With
VerDate Sep<11>2014 13:31 Dec 24, 2015 Jkt 238001 PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 E:\FR\FM\28DEN1.SGM 28DEN1](https://thefederalregister.org/doc/80_FR_81023/page/1.svg)
![80776 Federal Register / Vol. 80, No. 248 / Monday, December 28, 2015 / Notices
Therapeutic Equivalence Evaluations,’’ evaluated relevant literature and data areas, using the process established
which is known generally as the for possible postmarketing adverse through Patient-Focused Drug
‘‘Orange Book.’’ Under FDA regulations, events. We have reviewed the available Development as a model.
drugs are removed from the list if the evidence and determined that the ADDRESSES: FDA recommends that
Agency withdraws or suspends products were not withdrawn from sale patient organizations who are interested
approval of the drug’s NDA or ANDA for reasons of safety or effectiveness. in conducting an externally-led PFDD
for reasons of safety or effectiveness or Accordingly, the Agency will meeting initially engage with FDA by
if FDA determines that the listed drug continue to list KYTRIL (granisteron submitting a letter of intent (LOI) to
was withdrawn from sale for reasons of hydrochloride) tablets, EQ 1 mg and 2 patientfocused@fda.hhs.gov.
safety or effectiveness (21 CFR 314.162). mg base, in the ‘‘Discontinued Drug Submission details are outlined on
A person may petition the Agency to Product List’’ section of the Orange FDA’s Web site: http://www.fda.gov/
determine, or the Agency may Book. The ‘‘Discontinued Drug Product ForIndustry/UserFees/
determine on its own initiative, whether List’’ delineates, among other items, PrescriptionDrugUserFee/
a listed drug was withdrawn from sale drug products that have been ucm453856.htm.
for reasons of safety or effectiveness. discontinued from marketing for reasons FOR FURTHER INFORMATION CONTACT:
This determination may be made at any other than safety or effectiveness. Pujita Vaidya, Center for Drug
time after the drug has been withdrawn ANDAs that refer to KYTRIL Evaluation and Research, Food and
from sale, but must be made prior to (granisteron hydrochloride) tablets, EQ Drug Administration, 10903 New
approving an ANDA that refers to the 1 mg and 2 mg base, may be approved Hampshire Ave., Bldg. 51, rm. 1144,
listed drug (§ 314.161 (21 CFR 314.161)). by the Agency as long as they meet all Silver Spring, MD 20993–0002, 301–
FDA may not approve an ANDA that other legal and regulatory requirements 796–0684.
does not refer to a listed drug. for the approval of ANDAs. If FDA
KYTRIL (granisetron hydrochloride) SUPPLEMENTARY INFORMATION: As part of
determines that labeling for this drug its commitments under the Prescription
tablets, EQ 1 mg and 2 mg base, are the product should be revised to meet
subject of NDA 020305, held by Drug User Fee Act reauthorization of
current standards, the Agency will 2012, FDA has taken several steps to
Hoffmann-La Roche, Inc., and initially advise ANDA applicants to submit such
approved on March 16, 1995. KYTRIL is inform the benefit-risk assessments that
labeling. inform CDER’s regulatory decisions
indicated for the prevention of nausea
and/or vomiting associated with initial Dated: December 21, 2015. concerning new drugs. Among these
and repeat courses of emetogenic cancer Leslie Kux, efforts is the PFDD initiative that aims
therapy, including high-dose cisplatin, Associate Commissioner for Policy. to more systematically obtain the
and for the prevention and treatment of [FR Doc. 2015–32496 Filed 12–24–15; 8:45 am] patient perspective on specific diseases
postoperative nausea and vomiting in BILLING CODE 4164–01–P
and their treatments. FDA has
adults. committed to obtaining the patient
On April 30, 2012, Hoffman-La Roche perspective on at least 20 disease areas
notified FDA that KYTRIL (granisteron DEPARTMENT OF HEALTH AND during the course of PDUFA V. PFDD
hydrochloride) tablets, EQ 1 mg and 2 HUMAN SERVICES meetings give FDA an important
mg base, were being discontinued, and opportunity to hear directly from
FDA moved the drug products to the Food and Drug Administration patients, patient advocates, and
‘‘Discontinued Drug Product List’’ caretakers about the symptoms that
[Docket No. FDA–2015–N–0001]
section of the Orange Book. matter most to them; the impact the
Kurt R. Karst, on behalf of Hyman, Externally-Led Patient-Focused Drug disease has on patients’ daily lives; and
Phelps & McNamara, P.C., submitted a Development Meetings patients’ experiences with currently
citizen petition dated May 27, 2015 available treatments. The patient
(Docket No. FDA–2015–P–1898), under AGENCY: Food and Drug Administration, perspective is critical in helping FDA
21 CFR 10.30, requesting that the HHS. understand the context in which
Agency determine whether KYTRIL ACTION: Notice. regulatory decisions are made for new
(granisteron hydrochloride) tablets, EQ drugs. This patient input can inform
1 mg and 2 mg base, were withdrawn SUMMARY: The Food and Drug FDA’s decisions and oversight both
from sale for reasons of safety or Administration (FDA or Agency) is during drug development and during
effectiveness. announcing the opportunity for our review of a marketing application.
After considering the citizen petition externally-led patient-focused drug The Agency recognizes that there has
and reviewing Agency records and development meetings. The Patient- been growing external interest in
based on the information we have at this Focused Drug Development (PFDD) expanding efforts to gather patient input
time, FDA has determined under initiative is part of FDA’s commitments in support of drug development and
§ 314.161 that KYTRIL (granisteron under the fifth authorization of the evaluation. To help expand the benefits
hydrochloride) tablets, EQ 1 mg and 2 Prescription Drug User Fee Act (PDUFA of FDA’s PFDD initiative, FDA
mg base, were not withdrawn for V). The PFDD initiative aims to more welcomes patient organizations to
reasons of safety or effectiveness. The systematically obtain the patient identify and organize patient-focused
petitioner has identified no data or other perspective on specific diseases and collaborations to generate public input
information suggesting that KYTRIL their treatments. FDA recognizes that on other disease areas, using the process
mstockstill on DSK4VPTVN1PROD with NOTICES
(granisteron hydrochloride) tablets, EQ there are many more disease areas than established through Patient-Focused
1 mg and 2 mg base, were withdrawn for can be addressed in the planned FDA Drug Development as a model. An
reasons of safety or effectiveness We meetings under PDUFA V. To help externally-led PFDD meeting and any
have carefully reviewed our files for expand the benefits of FDA’s PFDD resulting products (e.g., surveys or
records concerning the withdrawal of initiative, FDA welcomes patient reports) will not be considered FDA-
KYTRIL (granisteron hydrochloride) organizations to identify and organize sponsored or FDA-endorsed, and FDA
tablets, EQ 1 mg and 2 mg base, from patient-focused collaborations to does not guarantee specific involvement
sale. We have also independently generate public input on other disease in such meetings. However, FDA will be
VerDate Sep<11>2014 13:31 Dec 24, 2015 Jkt 238001 PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 E:\FR\FM\28DEN1.SGM 28DEN1](https://thefederalregister.org/doc/80_FR_81023/page/2.svg)
Document Created: 2018-03-02 09:24:36
Document Modified: 2018-03-02 09:24:36
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Contact | Daniel Orr, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6246, Silver Spring, MD 20993-0002, 240-402-0979. | |
| FR Citation | 80 FR 80775 |
2024 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR