83 FR 8089 - Sebela Ireland, Ltd. et al.; Withdrawal of Approval of 24 Abbreviated New Drug Applications
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 37 (February 23, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 37 (February 23, 2018)
| Page Range | 8089-8090 | |
| FR Document | 2018-03700 |
[Federal Register Volume 83, Number 37 (Friday, February 23, 2018)] [Notices] [Pages 8089-8090] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-03700] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-0478] Sebela Ireland, Ltd. et al.; Withdrawal of Approval of 24 Abbreviated New Drug Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is withdrawing approval of 24 abbreviated [[Page 8090]] new drug applications (ANDAs) from multiple applicants. The holders of the applications 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn. DATES: Approval is withdrawn as of March 26, 2018. FOR FURTHER INFORMATION CONTACT: Trang Tran, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1671, Silver Spring, MD 20993-0002, 240-402-7945, Trang.Tran@fda.hhs.gov. SUPPLEMENTARY INFORMATION: The holders of the applications 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 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. ------------------------------------------------------------------------ Application No. Drug Applicant ------------------------------------------------------------------------ ANDA 040398............ MiCort-HC Sebela Ireland, Ltd., (hydrocortisone c/o Sebela acetate) Cream USP, 2%. Pharmaceuticals, Inc., 645 Hembree Parkway, Suite 1, Roswell, GA 30076. ANDA 071893............ Acetohexamide Tablets, Watson Laboratories, 250 milligrams (mg). Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044. ANDA 071894............ Acetohexamide Tablets, Do. 500 mg. ANDA 073143............ Cyclobenzaprine Do. Hydrochloride (HCl) Tablets USP, 10 mg. ANDA 074576............ Captopril Tablets USP, Do. 12.5 mg, 25 mg, 50 mg, and 100 mg. ANDA 076607............ Quinapril Tablets USP, Sun Pharmaceutical Equivalent to (EQ) 5 Industries, Ltd., c/o mg base, EQ 10 mg Sun Pharmaceutical base, EQ 20 mg base, Industries, Inc., 2 and EQ 40 mg base. Independence Way, Princeton, NJ 08540. ANDA 076786............ Donepezil HCl Tablets Do. USP, 5 mg and 10 mg. ANDA 077483............ Benazepril HCl and Do. Hydrochlorothiazide Tablets, 5 mg/6.25 mg, 10 mg/12.5 mg, 20 mg/ 12.5 mg, and 20 mg/25 mg. ANDA 078502............ Eliphos (calcium Cypress acetate) Tablets USP, Pharmaceutical, Inc., 667 mg. 10 North Park Pl., Suite 201, Morristown, NJ 07960. ANDA 081019............ Chlorzoxazone Tablets Watson Laboratories, USP, 500 mg. Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. ANDA 083821............ Brompheniramine Maleate Do. Injection, 10 mg/ milliliter (mL). ANDA 084408............ Bethanechol Chloride Do. Tablets USP, 10 mg. ANDA 084441............ Bethanechol Chloride Do. Tablets USP, 25 mg. ANDA 085283............ Theolair (theophylline) 3M Drug Delivery Tablets, 125 mg and Systems, 3M Center, 250 mg. Bldg. 275-3E-02, 2510 Conway Ave., St. Paul, MN 55144. ANDA 085738............ Betamethasone Sodium Watson Laboratories, Phosphate Injection, Inc., Subsidiary of EQ 3 mg base/mL. Teva Pharmaceuticals USA, Inc. ANDA 087444............ Bethanechol Chloride Watson Laboratories, Tablets USP, 50 mg. Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. ANDA 087792............ Fluorouracil Injection Spectrum USP, 50 mg/mL. Pharmaceuticals, Inc., 157 Technology Dr., Irvine, CA 92618. ANDA 087978............ Diphenhydramine HCl LNK International, Capsules, 50 mg. Inc., 145 Ricefield Ln., Hauppauge, NY 11788. ANDA 090417............ Carbinoxamine Maleate Cypress Tablets USP, 4 mg. Pharmaceutical, Inc. ANDA 090418............ Carbinoxamine Maleate Do. Oral Solution, 4 mg/5 mL. ANDA 090468............ Zyfrel (acetaminophen Do. and hydrocodone bitartrate) Oral Solution, 325 mg/7.5 mg per 15 mL. ANDA 091034............ Dorzolamide HCl Zambon S.p.A., c/o Ophthalmic Solution Camargo USP, EQ 2% base. Pharmaceutical Services, LLC, 9825 Kenwood Rd., Suite 203, Cincinnati, OH 45242. ANDA 200794............ Pantoprazole Sodium Sun Pharmaceutical Delayed-Release Industries, Ltd., c/o Tablets USP, EQ 20 mg Sun Pharmaceutical base and EQ 40 mg base. Industries, Inc. ANDA 206438............ Hydrocodone Bitartrate Tris Pharma, Inc., and Chlorpheniramine 2033 Route 130, Suite Maleate Oral Solution, D, Monmouth Junction, 5 mg/4 mg per 5 mL. NJ 08852. ------------------------------------------------------------------------ Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of March 26, 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 March 26, 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: February 16, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-03700 Filed 2-22-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 37 / Friday, February 23, 2018 / Notices 8089
docket number, found in brackets in the who have received at least two prior verified the applicant’s claims that NDA
heading of this document, into the systemic therapies. 206545 was approved on July 23, 2014.
‘‘Search’’ box and follow the prompts • Relapsed small lymphocytic This determination of the regulatory
and/or go to the Dockets Management lymphoma (SLL) in patients who have review period establishes the maximum
Staff, 5630 Fishers Lane, Rm. 1061, received at least two prior systemic potential length of a patent extension.
Rockville, MD 20852. therapies. However, the USPTO applies several
FOR FURTHER INFORMATION CONTACT:
Accelerated approval was granted for statutory limitations in its calculations
Beverly Friedman, Office of Regulatory FL and SLL based on overall response of the actual period for patent extension.
Policy, Food and Drug Administration, rate. Improvement in patient survival or In its applications for patent extension,
10903 New Hampshire Ave., Bldg. 51, disease related symptoms has not been this applicant seeks 494 days or 708
Rm. 6250, Silver Spring, MD 20993, established. Continued approval for days of patent term extension.
301–796–3600. these indications may be contingent
upon verification of clinical benefit in III. Petitions
SUPPLEMENTARY INFORMATION: confirmatory trials. Anyone with knowledge that any of
I. Background Subsequent to the approvals, the the dates as published are incorrect may
USPTO received patent term restoration submit either electronic or written
The Drug Price Competition and applications for ZYDELIG (U.S. Patent comments and, under 21 CFR 60.24, ask
Patent Term Restoration Act of 1984 Nos. RE44599 and RE44638) from ICOS for a redetermination (see DATES).
(Pub. L. 98–417) and the Generic Corporation, and the USPTO requested Furthermore, as specified in § 60.30 (21
Animal Drug and Patent Term FDA’s assistance in determining the CFR 60.30), any interested person may
Restoration Act (Pub. L. 100–670) patents’ eligibility for patent term petition FDA for a determination
generally provide that a patent may be restoration. In a letter dated November regarding whether the applicant for
extended for a period of up to 5 years 4, 2015, FDA advised the USPTO that extension acted with due diligence
so long as the patented item (human this human drug product had undergone during the regulatory review period. To
drug product, animal drug product, a regulatory review period and that the meet its burden, the petition must
medical device, food additive, or color approvals of ZYDELIG under NDA comply with all the requirements of
additive) was subject to regulatory 206545 and NDA 205858 represented § 60.30, including but not limited to:
review by FDA before the item was the first permitted commercial must be timely (see DATES), must be
marketed. Under these acts, a product’s marketing or use of the product. filed in accordance with § 10.20, must
regulatory review period forms the basis Thereafter, the USPTO requested that contain sufficient facts to merit an FDA
for determining the amount of extension FDA determine the product’s regulatory investigation, and must certify that a
an applicant may receive. review period. true and complete copy of the petition
A regulatory review period consists of has been served upon the patent
two periods of time: A testing phase and II. Determination of Regulatory Review
applicant. (See H. Rept. 857, part 1, 98th
an approval phase. For human drug Period
Cong., 2d sess., pp. 41–42, 1984.)
products, the testing phase begins when FDA has determined that the Petitions should be in the format
the exemption to permit the clinical applicable regulatory review period for specified in 21 CFR 10.30.
investigations of the drug becomes ZYDELIG is 2,247 days. Of this time, Submit petitions electronically to
effective and runs until the approval 2,017 days occurred during the testing https://www.regulations.gov at Docket
phase begins. The approval phase starts phase of the regulatory review period, No. FDA–2013–S–0610. Submit written
with the initial submission of an while 230 days occurred during the petitions (two copies are required) to the
application to market the human drug approval phase. These periods of time Dockets Management Staff (HFA–305),
product and continues until FDA grants were derived from the following dates: Food and Drug Administration, 5630
permission to market the drug product. 1. The date an exemption under Fishers Lane, Rm. 1061, Rockville, MD
Although only a portion of a regulatory section 505(i) of the Federal Food, Drug, 20852.
review period may count toward the and Cosmetic Act (the FD&C Act) (21 Dated: February 16, 2018.
actual amount of extension that the U.S.C. 355(i)) became effective: May 30,
Director of USPTO may award (for Leslie Kux,
2008. FDA has verified the applicant’s
example, half the testing phase must be Associate Commissioner for Policy.
claim that the date the investigational
subtracted as well as any time that may new drug application (IND) became [FR Doc. 2018–03701 Filed 2–22–18; 8:45 am]
have occurred before the patent was effective was on May 30, 2008. This is BILLING CODE 4164–01–P
issued), FDA’s determination of the the same IND and the same date FDA
length of a regulatory review period for determined as the beginning of the
a human drug product will include all regulatory review period for ZYDELIG DEPARTMENT OF HEALTH AND
of the testing phase and approval phase approved under NDA 205858. The HUMAN SERVICES
as specified in 35 U.S.C. 156(g)(1)(B). regulatory review period for ZYDELIG Food and Drug Administration
FDA has approved for marketing the approved under NDA 205858 is
human drug product ZYDELIG publishing in this issue of the Federal [Docket No. FDA–2018–N–0478]
(idelalisib). As approved in both NDA Register.
206545 and NDA 205858, ZYDELIG is 2. The date the application was Sebela Ireland, Ltd. et al.; Withdrawal
indicated for treatment of patients with: initially submitted with respect to the of Approval of 24 Abbreviated New
• Relapsed chronic lymphocytic human drug product under section Drug Applications
daltland on DSKBBV9HB2PROD with NOTICES
leukemia in combination with 505(b) of the FD&C Act: December 6, AGENCY: Food and Drug Administration,
rituximab, in patients for whom 2013. FDA has verified the applicant’s HHS.
rituximab alone would be considered claims that the NDA for ZYDELIG (NDA ACTION: Notice.
appropriate therapy due to other co- 206545) was initially submitted on
morbidities. December 6, 2013. SUMMARY: The Food and Drug
• Relapsed follicular B-cell non- 3. The date the application was Administration (FDA or Agency) is
Hodgkin lymphoma (FL) in patients approved: July 23, 2014. FDA has withdrawing approval of 24 abbreviated
VerDate Sep<11>2014 18:52 Feb 22, 2018 Jkt 244001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 E:\FR\FM\23FEN1.SGM 23FEN1](https://thefederalregister.org/doc/83_FR_8126/page/1.svg)
![8090 Federal Register / Vol. 83, No. 37 / Friday, February 23, 2018 / Notices
new drug applications (ANDAs) from FOR FURTHER INFORMATION CONTACT: have requested that FDA withdraw
multiple applicants. The holders of the Trang Tran, Center for Drug Evaluation approval of the applications under the
applications notified the Agency in and Research, Food and Drug process in § 314.150(c) (21 CFR
writing that the drug products were no Administration, 10903 New Hampshire 314.150(c)). The applicants have also,
longer marketed and requested that the Ave., Bldg. 75, Rm. 1671, Silver Spring, by their requests, waived their
approval of the applications be MD 20993–0002, 240–402–7945, opportunity for a hearing. Withdrawal
withdrawn. Trang.Tran@fda.hhs.gov. of approval of an application or
SUPPLEMENTARY INFORMATION: The abbreviated application under
DATES:Approval is withdrawn as of holders of the applications listed in the § 314.150(c) is without prejudice to
March 26, 2018. table have informed FDA that these drug refiling.
products are no longer marketed and
Application No. Drug Applicant
ANDA 040398 .... MiCort-HC (hydrocortisone acetate) Cream USP, 2% ............ Sebela Ireland, Ltd., c/o Sebela Pharmaceuticals, Inc., 645
Hembree Parkway, Suite 1, Roswell, GA 30076.
ANDA 071893 .... Acetohexamide Tablets, 250 milligrams (mg) ......................... Watson Laboratories, Inc., Subsidiary of Teva Pharma-
ceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044.
ANDA 071894 .... Acetohexamide Tablets, 500 mg ............................................. Do.
ANDA 073143 .... Cyclobenzaprine Hydrochloride (HCl) Tablets USP, 10 mg .... Do.
ANDA 074576 .... Captopril Tablets USP, 12.5 mg, 25 mg, 50 mg, and 100 mg Do.
ANDA 076607 .... Quinapril Tablets USP, Equivalent to (EQ) 5 mg base, EQ 10 Sun Pharmaceutical Industries, Ltd., c/o Sun Pharmaceutical
mg base, EQ 20 mg base, and EQ 40 mg base. Industries, Inc., 2 Independence Way, Princeton, NJ
08540.
ANDA 076786 .... Donepezil HCl Tablets USP, 5 mg and 10 mg ........................ Do.
ANDA 077483 .... Benazepril HCl and Hydrochlorothiazide Tablets, 5 mg/6.25 Do.
mg, 10 mg/12.5 mg, 20 mg/12.5 mg, and 20 mg/25 mg.
ANDA 078502 .... Eliphos (calcium acetate) Tablets USP, 667 mg ..................... Cypress Pharmaceutical, Inc., 10 North Park Pl., Suite 201,
Morristown, NJ 07960.
ANDA 081019 .... Chlorzoxazone Tablets USP, 500 mg ..................................... Watson Laboratories, Inc., Subsidiary of Teva Pharma-
ceuticals USA, Inc.
ANDA 083821 .... Brompheniramine Maleate Injection, 10 mg/milliliter (mL) ...... Do.
ANDA 084408 .... Bethanechol Chloride Tablets USP, 10 mg ............................. Do.
ANDA 084441 .... Bethanechol Chloride Tablets USP, 25 mg ............................. Do.
ANDA 085283 .... Theolair (theophylline) Tablets, 125 mg and 250 mg .............. 3M Drug Delivery Systems, 3M Center, Bldg. 275–3E–02,
2510 Conway Ave., St. Paul, MN 55144.
ANDA 085738 .... Betamethasone Sodium Phosphate Injection, EQ 3 mg base/ Watson Laboratories, Inc., Subsidiary of Teva Pharma-
mL. ceuticals USA, Inc.
ANDA 087444 .... Bethanechol Chloride Tablets USP, 50 mg ............................. Watson Laboratories, Inc., Subsidiary of Teva Pharma-
ceuticals USA, Inc.
ANDA 087792 .... Fluorouracil Injection USP, 50 mg/mL ..................................... Spectrum Pharmaceuticals, Inc., 157 Technology Dr., Irvine,
CA 92618.
ANDA 087978 .... Diphenhydramine HCl Capsules, 50 mg ................................. LNK International, Inc., 145 Ricefield Ln., Hauppauge, NY
11788.
ANDA 090417 .... Carbinoxamine Maleate Tablets USP, 4 mg ........................... Cypress Pharmaceutical, Inc.
ANDA 090418 .... Carbinoxamine Maleate Oral Solution, 4 mg/5 mL ................. Do.
ANDA 090468 .... Zyfrel (acetaminophen and hydrocodone bitartrate) Oral So- Do.
lution, 325 mg/7.5 mg per 15 mL.
ANDA 091034 .... Dorzolamide HCl Ophthalmic Solution USP, EQ 2% base ..... Zambon S.p.A., c/o Camargo Pharmaceutical Services, LLC,
9825 Kenwood Rd., Suite 203, Cincinnati, OH 45242.
ANDA 200794 .... Pantoprazole Sodium Delayed-Release Tablets USP, EQ 20 Sun Pharmaceutical Industries, Ltd., c/o Sun Pharmaceutical
mg base and EQ 40 mg base. Industries, Inc.
ANDA 206438 .... Hydrocodone Bitartrate and Chlorpheniramine Maleate Oral Tris Pharma, Inc., 2033 Route 130, Suite D, Monmouth
Solution, 5 mg/4 mg per 5 mL. Junction, NJ 08852.
Therefore, approval of the expiration dates or otherwise become DEPARTMENT OF HEALTH AND
applications listed in the table, and all violative, whichever occurs first. HUMAN SERVICES
amendments and supplements thereto, Dated: February 16, 2018.
is hereby withdrawn as of March 26, Meeting of the Secretary’s Advisory
Leslie Kux, Committee on Human Research
2018. Introduction or delivery for
Associate Commissioner for Policy. Protections
introduction into interstate commerce of
[FR Doc. 2018–03700 Filed 2–22–18; 8:45 am]
products without approved new drug AGENCY: Office of the Assistant
applications violates section 301(a) and BILLING CODE 4164–01–P
Secretary for Health, Office of the
(d) of the Federal Food, Drug, and Secretary, Department of Health and
daltland on DSKBBV9HB2PROD with NOTICES
Cosmetic Act (21 U.S.C. 331(a) and (d)). Human Services.
Drug products that are listed in the table ACTION: Notice.
that are in inventory on March 26, 2018
may continue to be dispensed until the SUMMARY: Pursuant to Section 10(a) of
inventories have been depleted or the the Federal Advisory Committee Act,
drug products have reached their notice is hereby given that the
Secretary’s Advisory Committee on
VerDate Sep<11>2014 18:52 Feb 22, 2018 Jkt 244001 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 E:\FR\FM\23FEN1.SGM 23FEN1](https://thefederalregister.org/doc/83_FR_8126/page/2.svg)
Document Created: 2018-02-23 01:32:47
Document Modified: 2018-02-23 01:32:47
| 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 March 26, 2018. | |
| Contact | Trang Tran, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1671, Silver Spring, MD 20993-0002, 240-402-7945, [email protected] | |
| FR Citation | 83 FR 8089 |
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