83 FR 53068 - Sanofi-Aventis, U.S., LLC, et al.; Withdrawal of Approval of 20 New Drug Applications
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 203 (October 19, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 203 (October 19, 2018)
| Page Range | 53068-53069 | |
| FR Document | 2018-22805 |
[Federal Register Volume 83, Number 203 (Friday, October 19, 2018)] [Notices] [Pages 53068-53069] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-22805] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-3761] Sanofi-Aventis, U.S., LLC, et al.; Withdrawal of Approval of 20 New Drug Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is withdrawing approval of 20 new drug applications (NDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn. DATES: Approval is withdrawn as of November 19, 2018. FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6248, Silver Spring, MD 20993-0002, 301- 796-3601. SUPPLEMENTARY INFORMATION: The applicants listed in the table have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications under the process described in Sec. 314.150(c) (21 CFR 314.150(c)). The applicants have also, by their requests, waived their opportunity for a hearing. Withdrawal of approval of an application or abbreviated application under Sec. 314.150(c) is without prejudice to refiling. [[Page 53069]] ---------------------------------------------------------------------------------------------------------------- Application No. Drug Applicant ---------------------------------------------------------------------------------------------------------------- NDA 006002....................... Aralen Hydrochloride (chloroquine Sanofi-Aventis, U.S., LLC, 55 Corporate hydrochloride (HCl)) Injection, Dr., Bridgewater, NJ 08807. Equivalent to (EQ) 40 milligram (mg) base/milliliter (mL); Aralen (chloroquine phosphate) Tablets, EQ 300 mg base. NDA 008107....................... Leucovorin calcium for Injection Hospira Inc., Subsidiary of Pfizer Inc., USP, EQ 60 mg base/vial for 235 East 42nd St., New York, NY 10017. solution, oral; EQ 3 mg base/mL injection; EQ 50 mg base/vial injection; EQ 100 mg base/vial injection; EQ 350 mg base/vial injection. NDA 009321....................... Cholografin Meglumine (iodipamide Bracco Diagnostics, Inc., 259 Prospect meglumine) Injection, 10.3% and Plains Rd., Monroe Township, NJ 08831. 52% (cholografin sodium, 20%). NDA 017566....................... Brevicon (ethinyl estradiol; Allergan Pharmaceuticals International, norethindrone) Tablets, 0.035 mg/ Ltd., c/o Allergan Sales, LLC, 2525 0.5 mg (21-Day Regimen). Dupont Dr., Irvine, CA 92612. NDA 018181....................... Mycelex (clotrimazole) Topical Bayer HealthCare LLC, 100 Bayer Blvd., 100 Solution, 1%. Bayer Rd., Pittsburgh, PA 15205. NDA 018182....................... Mycelex-7 (clotrimazole) Tablets, Do. 100 mg. NDA 018183....................... Mycelex (clotrimazole) Topical Do. Cream, 1%. NDA 018230....................... Mycelex-7 (clotrimazole) Topical Do. Vaginal Cream, 1%. NDA 018856....................... D-Xylose (xylose) Powder, 25 Lyne Laboratories, 10 Burke Dr., Brockton, grams (g)/bottle. MA 02301. NDA 018874....................... Calcijex (calcitriol) Injection, AbbVie, Inc., 1 North Waukegan Rd., North 0.001 mg/mL and 0.002 mg/mL. Chicago, IL 60064. NDA 020214....................... Zemuron (rocronium bromide) Organon USA Inc., Subsidiary of Merck & Injection, 50 mg/5 mL (10 mg/ Co., Inc., 2000 Galloping Hill Rd., mL); 10 mg/mL (10 mg/mL); 100 mg/ Kenilworth, NJ 07033. 10 mL (10 mg/mL). NDA 020389....................... Mycelex-7 Combination Pack Bayer HealthCare LLC. (clotrimazole) Topical Vaginal Cream and Tablets, 1%, 100 mg. NDA 020528....................... Mavik (trandolapril) Tablets, 1 AbbVie, Inc. mg, 2 mg, and 4 mg. NDA 020738....................... Teveten (eprosartan mesylate) Do. Tablets, 300 mg, 400 mg, and 600 mg. NDA 020863....................... Pletal (cilostazol) Tablets, 50 Otsuka Pharmaceutical Development and mg and 100 mg. Commercialization, Subsidiary of Otsuka Pharmaceutical Company, Ltd., 2440 Research Blvd., Rockville, MD 20850. NDA 021268....................... Teveten HCT (eprosartan mesylate AbbVie, Inc. and hydrochlorothiazide) Tablets, 600/12.5 mg and 600/25 mg. NDA 021410....................... Avandamet (rosiglitazone maleate GlaxoSmithKline, 1250 South Collegeville and metformin hydrochloride Rd., Collegeville, PA 19426. (HCl)) Tablets, 500 mg EQ 1 mg base; 500 mg EQ 2 mg base; 500 mg EQ 4 mg base; 1 g EQ 2 mg base; 1 g EQ 4 mg base. NDA 021511....................... Copegus (ribavirin) Tablets, 200 Hoffmann La-Roche, Inc., Subsidiary of mg and 400 mg. Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080. NDA 021700....................... Avandaryl (glimepiride and SB Pharmco Puerto Rico Inc., Subsidiary of rosiglitazone maleate) Tablets, GlaxoSmithKline, 1250 South Collegeville 1 mg/4 mg; 2 mg/4 mg; 2 mg/8 mg; Rd., Collegeville, PA 19426. 4 mg/4 mg; 4 mg/8 mg. NDA 205123....................... Olysio (simeprevir sodium) Janssen Pharmaceuticals, Inc., 1000 U.S. Capsules, EQ 150 mg base. Rte. 202 South, Raritan, NJ 08869. ---------------------------------------------------------------------------------------------------------------- Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of November 19, 2018. Introduction or delivery for introduction into interstate commerce of products without approved new drug applications violates section 301(a) and (d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(a) and (d)). Drug products that are listed in the table that are in inventory on November 19, 2018 may continue to be dispensed until the inventories have been depleted or the drug products have reached their expiration dates or otherwise become violative, whichever occurs first. Dated: October 15, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-22805 Filed 10-18-18; 8:45 am] BILLING CODE 4164-01-P
![53068 Federal Register / Vol. 83, No. 203 / Friday, October 19, 2018 / Notices
review by FDA before the item was II. Determination of Regulatory Review Submit petitions electronically to
marketed. Under these acts, a product’s Period https://www.regulations.gov at Docket
regulatory review period forms the basis No. FDA–2013–S–0610. Submit written
FDA has determined that the
for determining the amount of extension petitions (two copies are required) to the
applicable regulatory review period for
an applicant may receive. IMFINZI is 1,755 days. Of this time, Dockets Management Staff (HFA–305),
A regulatory review period consists of 1,554 days occurred during the testing Food and Drug Administration, 5630
two periods of time: a testing phase and phase of the regulatory review period, Fishers Lane, Rm. 1061, Rockville, MD
an approval phase. For human while 201 days occurred during the 20852.
biological products, the testing phase approval phase. These periods of time Dated: October 15, 2018.
begins when the exemption to permit were derived from the following dates: Leslie Kux,
the clinical investigations of the 1. The date an exemption under
Associate Commissioner for Policy.
biological product becomes effective section 505(i) of the Federal Food, Drug,
[FR Doc. 2018–22806 Filed 10–18–18; 8:45 am]
and runs until the approval phase and Cosmetic Act (21 U.S.C. 355(i))
begins. The approval phase starts with became effective: July 13, 2012. FDA has BILLING CODE 4164–01–P
the initial submission of an application verified the applicant’s claim that the
to market the human biological product date the initial investigational new drug
and continues until FDA grants application became effective was on DEPARTMENT OF HEALTH AND
permission to market the biological July 13, 2012. HUMAN SERVICES
product. Although only a portion of a 2. The date the application was
regulatory review period may count Food and Drug Administration
initially submitted with respect to the
toward the actual amount of extension human biological product under section
that the Director of USPTO may award 351 of the Public Health Service Act (42 [Docket No. FDA–2018–N–3761]
(for example, half the testing phase must U.S.C. 262): October 13, 2016. FDA has
be subtracted as well as any time that verified the applicant’s claim that the Sanofi-Aventis, U.S., LLC, et al.;
may have occurred before the patent biologics license application (BLA) for Withdrawal of Approval of 20 New
was issued), FDA’s determination of the IMFINZI (BLA 761069) was initially Drug Applications
length of a regulatory review period for submitted on October 13, 2016.
a human biological product will include 3. The date the application was AGENCY: Food and Drug Administration,
all of the testing phase and approval approved: May 1, 2017. FDA has HHS.
phase as specified in 35 U.S.C. verified the applicant’s claim that BLA ACTION: Notice.
156(g)(1)(B). 761069 was approved on May 1, 2017.
FDA has approved for marketing the This determination of the regulatory SUMMARY: The Food and Drug
human biologic product IMFINZI review period establishes the maximum Administration (FDA or Agency) is
(durvalumab). IMFINZI is indicated for potential length of a patent extension.
withdrawing approval of 20 new drug
the treatment of patients with locally However, the USPTO applies several
applications (NDAs) from multiple
advanced or metastatic urothelial statutory limitations in its calculations
applicants. The applicants notified the
carcinoma who have disease of the actual period for patent extension.
In its application for patent extension, Agency in writing that the drug
progression during or following
platinum-containing chemotherapy or this applicant seeks 159 days of patent products were no longer marketed and
who have disease progression within 12 term extension. requested that the approval of the
months of neoadjuvant or adjuvant applications be withdrawn.
III. Petitions
treatment with platinum-containing Approval is withdrawn as of
DATES:
chemotherapy. This indication is Anyone with knowledge that any of November 19, 2018.
approved under accelerated approval the dates as published are incorrect may
based on tumor response rate and submit either electronic or written FOR FURTHER INFORMATION CONTACT:
duration of response. Continued comments and, under 21 CFR 60.24, ask Florine P. Purdie, Center for Drug
approval for this indication may be for a redetermination (see DATES). Evaluation and Research, Food and
contingent upon verification and Furthermore, as specified in § 60.30 (21 Drug Administration, 10903 New
description of clinical benefit in CFR 60.30), any interested person may Hampshire Ave., Bldg. 51, Rm. 6248,
confirmatory trials. Subsequent to this petition FDA for a determination Silver Spring, MD 20993–0002, 301–
approval, the USPTO received a patent regarding whether the applicant for 796–3601.
term restoration application for IMFINZI extension acted with due diligence
(U.S. Patent Nos. 8,779,108 and during the regulatory review period. To SUPPLEMENTARY INFORMATION: The
9,493,565) from MedImmune Limited, meet its burden, the petition must applicants listed in the table have
and the USPTO requested FDA’s comply with all the requirements of informed FDA that these drug products
assistance in determining the patents’ § 60.30, including but not limited to: are no longer marketed and have
eligibility for patent term restoration. In must be timely (see DATES), must be requested that FDA withdraw approval
a letter dated, January 9, 2018, FDA filed in accordance with § 10.20, must of the applications under the process
advised the USPTO that this human contain sufficient facts to merit an FDA described in § 314.150(c) (21 CFR
amozie on DSK3GDR082PROD with NOTICES1
biological product had undergone a investigation, and must certify that a 314.150(c)). The applicants have also,
regulatory review period and that the true and complete copy of the petition by their requests, waived their
approval of IMFINZI represented the has been served upon the patent opportunity for a hearing. Withdrawal
first permitted commercial marketing or applicant. (See H. Rept. 857, part 1, 98th of approval of an application or
use of the product. Thereafter, the Cong., 2d sess., pp. 41–42, 1984.) abbreviated application under
USPTO requested that FDA determine Petitions should be in the format § 314.150(c) is without prejudice to
the product’s regulatory review period. specified in 21 CFR 10.30. refiling.
VerDate Sep<11>2014 18:10 Oct 18, 2018 Jkt 247001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 E:\FR\FM\19OCN1.SGM 19OCN1](https://thefederalregister.org/doc/83_FR_53271/page/1.svg)
![Federal Register / Vol. 83, No. 203 / Friday, October 19, 2018 / Notices 53069
Application No. Drug Applicant
NDA 006002 ...... Aralen Hydrochloride (chloroquine hydrochloride Sanofi-Aventis, U.S., LLC, 55 Corporate Dr., Bridgewater, NJ 08807.
(HCl)) Injection, Equivalent to (EQ) 40 milli-
gram (mg) base/milliliter (mL); Aralen
(chloroquine phosphate) Tablets, EQ 300 mg
base.
NDA 008107 ...... Leucovorin calcium for Injection USP, EQ 60 mg Hospira Inc., Subsidiary of Pfizer Inc., 235 East 42nd St., New York, NY
base/vial for solution, oral; EQ 3 mg base/mL 10017.
injection; EQ 50 mg base/vial injection; EQ
100 mg base/vial injection; EQ 350 mg base/
vial injection.
NDA 009321 ...... Cholografin Meglumine (iodipamide meglumine) Bracco Diagnostics, Inc., 259 Prospect Plains Rd., Monroe Township, NJ
Injection, 10.3% and 52% (cholografin sodium, 08831.
20%).
NDA 017566 ...... Brevicon (ethinyl estradiol; norethindrone) Tab- Allergan Pharmaceuticals International, Ltd., c/o Allergan Sales, LLC,
lets, 0.035 mg/0.5 mg (21-Day Regimen). 2525 Dupont Dr., Irvine, CA 92612.
NDA 018181 ...... Mycelex (clotrimazole) Topical Solution, 1% ....... Bayer HealthCare LLC, 100 Bayer Blvd., 100 Bayer Rd., Pittsburgh, PA
15205.
NDA 018182 ...... Mycelex-7 (clotrimazole) Tablets, 100 mg ........... Do.
NDA 018183 ...... Mycelex (clotrimazole) Topical Cream, 1% .......... Do.
NDA 018230 ...... Mycelex-7 (clotrimazole) Topical Vaginal Cream, Do.
1%.
NDA 018856 ...... D-Xylose (xylose) Powder, 25 grams (g)/bottle ... Lyne Laboratories, 10 Burke Dr., Brockton, MA 02301.
NDA 018874 ...... Calcijex (calcitriol) Injection, 0.001 mg/mL and AbbVie, Inc., 1 North Waukegan Rd., North Chicago, IL 60064.
0.002 mg/mL.
NDA 020214 ...... Zemuron (rocronium bromide) Injection, 50 mg/5 Organon USA Inc., Subsidiary of Merck & Co., Inc., 2000 Galloping Hill
mL (10 mg/mL); 10 mg/mL (10 mg/mL); 100 Rd., Kenilworth, NJ 07033.
mg/10 mL (10 mg/mL).
NDA 020389 ...... Mycelex-7 Combination Pack (clotrimazole) Top- Bayer HealthCare LLC.
ical Vaginal Cream and Tablets, 1%, 100 mg.
NDA 020528 ...... Mavik (trandolapril) Tablets, 1 mg, 2 mg, and 4 AbbVie, Inc.
mg.
NDA 020738 ...... Teveten (eprosartan mesylate) Tablets, 300 mg, Do.
400 mg, and 600 mg.
NDA 020863 ...... Pletal (cilostazol) Tablets, 50 mg and 100 mg .... Otsuka Pharmaceutical Development and Commercialization, Subsidiary
of Otsuka Pharmaceutical Company, Ltd., 2440 Research Blvd., Rock-
ville, MD 20850.
NDA 021268 ...... Teveten HCT (eprosartan mesylate and AbbVie, Inc.
hydrochlorothiazide) Tablets, 600/12.5 mg and
600/25 mg.
NDA 021410 ...... Avandamet (rosiglitazone maleate and metformin GlaxoSmithKline, 1250 South Collegeville Rd., Collegeville, PA 19426.
hydrochloride (HCl)) Tablets, 500 mg EQ 1 mg
base; 500 mg EQ 2 mg base; 500 mg EQ 4
mg base; 1 g EQ 2 mg base; 1 g EQ 4 mg
base.
NDA 021511 ...... Copegus (ribavirin) Tablets, 200 mg and 400 mg Hoffmann La-Roche, Inc., Subsidiary of Genentech, Inc., 1 DNA Way,
South San Francisco, CA 94080.
NDA 021700 ...... Avandaryl (glimepiride and rosiglitazone male- SB Pharmco Puerto Rico Inc., Subsidiary of GlaxoSmithKline, 1250
ate) Tablets, 1 mg/4 mg; 2 mg/4 mg; 2 mg/8 South Collegeville Rd., Collegeville, PA 19426.
mg; 4 mg/4 mg; 4 mg/8 mg.
NDA 205123 ...... Olysio (simeprevir sodium) Capsules, EQ 150 Janssen Pharmaceuticals, Inc., 1000 U.S. Rte. 202 South, Raritan, NJ
mg base. 08869.
Therefore, approval of the Dated: October 15, 2018. amended, notice is hereby given of the
applications listed in the table, and all Leslie Kux, following meetings.
amendments and supplements thereto, Associate Commissioner for Policy. The meetings will be closed to the
is hereby withdrawn as of November 19, [FR Doc. 2018–22805 Filed 10–18–18; 8:45 am] public in accordance with the
2018. Introduction or delivery for BILLING CODE 4164–01–P provisions set forth in sections
introduction into interstate commerce of 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
products without approved new drug as amended. The grant applications and
applications violates section 301(a) and DEPARTMENT OF HEALTH AND the discussions could disclose
(d) of the Federal Food, Drug, and HUMAN SERVICES confidential trade secrets or commercial
Cosmetic Act (21 U.S.C. 331(a) and (d)). property such as patentable material,
amozie on DSK3GDR082PROD with NOTICES1
Drug products that are listed in the table National Institutes of Health and personal information concerning
that are in inventory on November 19, individuals associated with the grant
2018 may continue to be dispensed National Heart, Lung, and Blood applications, the disclosure of which
until the inventories have been depleted Institute Notice of Closed Meetings would constitute a clearly unwarranted
or the drug products have reached their invasion of personal privacy.
expiration dates or otherwise become Pursuant to section 10(d) of the
Federal Advisory Committee Act, as Name of Committee: National Heart, Lung,
violative, whichever occurs first. and Blood Institute Special Emphasis Panel;
VerDate Sep<11>2014 17:25 Oct 18, 2018 Jkt 247001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 E:\FR\FM\19OCN1.SGM 19OCN1](https://thefederalregister.org/doc/83_FR_53271/page/2.svg)
Document Created: 2018-10-19 01:25:10
Document Modified: 2018-10-19 01:25:10
| 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. | |
| Dates | Approval is withdrawn as of November 19, 2018. | |
| Contact | Florine P. Purdie, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6248, Silver Spring, MD 20993-0002, 301- 796-3601. | |
| FR Citation | 83 FR 53068 |
2024 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR