82 FR 49214 - Watson Laboratories, Inc., and Barr Laboratories, Inc., Subsidiaries of Teva Pharmaceuticals USA, Inc.; Withdrawal of Approval of 54 Abbreviated New Drug Applications
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 204 (October 24, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 204 (October 24, 2017)
| Page Range | 49214-49215 | |
| FR Document | 2017-23046 |
[Federal Register Volume 82, Number 204 (Tuesday, October 24, 2017)] [Notices] [Pages 49214-49215] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-23046] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-5715] Watson Laboratories, Inc., and Barr Laboratories, Inc., Subsidiaries of Teva Pharmaceuticals USA, Inc.; Withdrawal of Approval of 54 Abbreviated New Drug Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval of 54 abbreviated new drug applications (ANDAs) from two 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn. DATES: Approval is withdrawn as of November 24, 2017. 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. SUPPLEMENTARY INFORMATION: The holders of the applications listed in table 1 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 abbreviated application under Sec. 314.150(c) is without prejudice to refiling. Table 1 ------------------------------------------------------------------------ Application No. Drug Applicant ------------------------------------------------------------------------ ANDA 061717.................. Doxycycline Hyclate Watson Capsules USP, Laboratories, Equivalent to (EQ) Inc., Subsidiary 50 milligrams (mg) of Teva base and EQ 100 mg Pharmaceuticals base. USA, Inc., 425 Privet Rd., Horsham, PA 19044. ANDA 062087.................. Erythromycin Do. Estolate Capsules USP, EQ 250 mg base. ANDA 062318.................. Gentamicin Injection Do. USP, EQ 10 mg base/ milliliter (mL) and EQ 40 mg base/mL. ANDA 062816.................. Ampicillin for Do. Injection USP, EQ 125 mg base/vial, EQ 250 mg base/ vial, EQ 500 mg base/vial, EQ 1 gram (g) base/vial, and EQ 2 g base/ vial. ANDA 062994.................. Ampicillin for Do. Injection USP, EQ 10 g base/vial. ANDA 062999.................. Erythromycin Delayed- Barr Laboratories, Release Tablets Inc., Subsidiary USP, 500 mg. of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044. ANDA 064036.................. Cefuroxime for Watson Injection USP, EQ Laboratories, 7.5 g base/vial. Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. ANDA 070296.................. Diazepam Injection Do. USP, 5 mg/mL. ANDA 070412.................. Furosemide Tablets Do. USP, 20 mg. ANDA 070435.................. Ibuprofen Tablets Do. USP, 200 mg. ANDA 070436.................. Ibuprofen Tablets Do. USP, 400 mg. ANDA 070437.................. Ibuprofen Tablets Do. USP, 600 mg. ANDA 070449.................. Furosemide Tablets Do. USP, 20 mg. ANDA 070450.................. Furosemide Tablets Do. USP, 40 mg. ANDA 070515.................. Tolazamide Tablets Do. USP, 500 mg. ANDA 070528.................. Furosemide Tablets Do. USP, 80 mg. ANDA 071238.................. Doxepin Do. Hydrochloride (HCl) Capsules USP, EQ 50 mg base. ANDA 071547.................. Ibuprofen Tablets Do. USP, 800 mg. ANDA 072397.................. Diazepam Injection Do. USP, 5 mg/mL. ANDA 072407.................. Fenoprofen Calcium Do. Tablets USP, EQ 600 mg base. ANDA 072602.................. Fenoprofen Calcium Do. Tablets USP, EQ 600 mg base. ANDA 072630.................. Albuterol Tablets Do. USP, EQ 4 mg base. ANDA 072825.................. Baclofen Tablets Do. USP, 20 mg. ANDA 073013.................. Metaproterenol Do. Sulfate Tablets USP, 10 mg. ANDA 073445.................. Meperidine HCl Do. Injection USP, 100 mg/mL. ANDA 074025.................. Guanabenz Acetate Do. Tablets USP, EQ 4 mg base and EQ 8 mg base. ANDA 074114.................. Dobutamine Injection Do. USP, EQ 12.5 mg base/mL. ANDA 074163.................. Naproxen Tablets Do. USP, 250 mg, 375 mg, and 500 mg. ANDA 074287.................. Piroxicam Capsules Do. USP, 10 mg and 20 mg. ANDA 074303.................. Pentamidine Do. Isethionate for Injection, 300 mg/ vial. ANDA 074437.................. Pindolol Tablets Do. USP, 5 mg and 10 mg. ANDA 074456.................. Alprazolam Tablets Do. USP, 0.25 mg, 0.5 mg, and 1 mg. ANDA 077643.................. Topiramate Tablets Do. USP, 25 mg, 50 mg, 100 mg, and 200 mg. ANDA 080728.................. Diphenhydramine HCl Do. Capsules USP, 25 mg. ANDA 080968.................. Dexamethasone Do. Tablets USP, 0.75 mg. ANDA 081040.................. Chlorzoxazone Do. Tablets USP, 500 mg. ANDA 081149.................. Hydroxyzine HCl Do. Tablets USP, 10 mg. ANDA 081189.................. Hydrochlorothiazide Do. Tablets USP, 25 mg. ANDA 081216.................. Estropipate Tablets Do. USP, 6 mg. ANDA 083232.................. Hydrochlorothiazide Do. Tablets USP, 50 mg. [[Page 49215]] ANDA 085720.................. Meprobamate Tablets Do. USP, 200 mg. ANDA 085721.................. Meprobamate Tablets Do. USP, 400 mg. ANDA 085778.................. Hydroxyzine HCl Do. Injection USP, 25 mg/mL. ANDA 086096.................. Chlorpheniramine Do. Maleate Injection USP, 10 mg/mL. ANDA 086189.................. Ergoloid Mesylates Do. Sublingual Tablets USP, 0.5 mg. ANDA 086598.................. Nandrolone Decanoate Do. Injection USP, 100 mg/mL. ANDA 086795.................. Chlorothiazide Do. Tablets USP, 250 mg. ANDA 087183.................. Ergoloid Mesylates Do. Sublingual Tablets USP, 1 mg. ANDA 087296.................. Chlorthalidone Do. Tablets USP, 25 mg. ANDA 087521.................. Chlorthalidone Do. Tablets USP, 50 mg. ANDA 087772.................. Prednisone Tablets Do. USP, 50 mg. ANDA 087979.................. Chloroquine Do. Phosphate Tablets USP, EQ 150 mg base. ANDA 088030.................. Chloroquine Do. Phosphate Tablets USP, EQ 300 mg base. ANDA 089042.................. Procainamide HCl Do. Extended-Release Tablets USP, 750 mg. ------------------------------------------------------------------------ Therefore, approval of the applications listed in table 1, and all amendments and supplements thereto, is hereby withdrawn as of November 24, 2017. 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 table 1 that are in inventory on the date that this notice becomes effective (see the DATES section) 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 18, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-23046 Filed 10-23-17; 8:45 am] BILLING CODE 4164-01-P
![49214 Federal Register / Vol. 82, No. 204 / Tuesday, October 24, 2017 / Notices
Dated: October 19, 2017. ACTION: Notice. SUPPLEMENTARY INFORMATION: The
G. Matthew Warren, holders of the applications listed in
Director, Office of Scientific Integrity. SUMMARY: The Food and Drug table 1 have informed FDA that these
[FR Doc. 2017–23019 Filed 10–23–17; 8:45 am] Administration (FDA) is withdrawing drug products are no longer marketed
BILLING CODE 4164–01–P
approval of 54 abbreviated new drug and have requested that FDA withdraw
applications (ANDAs) from two approval of the applications under the
applicants. The holders of the process in § 314.150(c) (21 CFR
DEPARTMENT OF HEALTH AND applications notified the Agency in
314.150(c)). The applicants have also,
HUMAN SERVICES writing that the drug products were no
by their requests, waived their
longer marketed and requested that the
opportunity for a hearing. Withdrawal
Food and Drug Administration approval of the applications be
withdrawn. of approval of an abbreviated
[Docket No. FDA–2017–N–5715] application under § 314.150(c) is
DATES: Approval is withdrawn as of without prejudice to refiling.
Watson Laboratories, Inc., and Barr November 24, 2017.
Laboratories, Inc., Subsidiaries of Teva
FOR FURTHER INFORMATION CONTACT:
Pharmaceuticals USA, Inc.; Withdrawal
Trang Tran, Center for Drug Evaluation
of Approval of 54 Abbreviated New
and Research, Food and Drug
Drug Applications
Administration, 10903 New Hampshire
AGENCY: Food and Drug Administration, Ave., Bldg. 75, Rm. 1671, Silver Spring,
HHS. MD 20993–0002, 240–402–7945.
TABLE 1
Application No. Drug Applicant
ANDA 061717 ........ Doxycycline Hyclate Capsules USP, Equivalent to (EQ) 50 milligrams Watson Laboratories, Inc., Subsidiary of Teva
(mg) base and EQ 100 mg base. Pharmaceuticals USA, Inc., 425 Privet Rd.,
Horsham, PA 19044.
ANDA 062087 ........ Erythromycin Estolate Capsules USP, EQ 250 mg base ......................... Do.
ANDA 062318 ........ Gentamicin Injection USP, EQ 10 mg base/milliliter (mL) and EQ 40 mg Do.
base/mL.
ANDA 062816 ........ Ampicillin for Injection USP, EQ 125 mg base/vial, EQ 250 mg base/ Do.
vial, EQ 500 mg base/vial, EQ 1 gram (g) base/vial, and EQ 2 g
base/vial.
ANDA 062994 ........ Ampicillin for Injection USP, EQ 10 g base/vial ........................................ Do.
ANDA 062999 ........ Erythromycin Delayed-Release Tablets USP, 500 mg ............................. Barr Laboratories, Inc., Subsidiary of Teva
Pharmaceuticals USA, Inc., 425 Privet Rd.,
Horsham, PA 19044.
ANDA 064036 ........ Cefuroxime for Injection USP, EQ 7.5 g base/vial ................................... Watson Laboratories, Inc., Subsidiary of Teva
Pharmaceuticals USA, Inc.
ANDA 070296 ........ Diazepam Injection USP, 5 mg/mL ........................................................... Do.
ANDA 070412 ........ Furosemide Tablets USP, 20 mg .............................................................. Do.
ANDA 070435 ........ Ibuprofen Tablets USP, 200 mg ............................................................... Do.
ANDA 070436 ........ Ibuprofen Tablets USP, 400 mg ............................................................... Do.
ANDA 070437 ........ Ibuprofen Tablets USP, 600 mg ............................................................... Do.
ANDA 070449 ........ Furosemide Tablets USP, 20 mg .............................................................. Do.
ANDA 070450 ........ Furosemide Tablets USP, 40 mg .............................................................. Do.
ANDA 070515 ........ Tolazamide Tablets USP, 500 mg ............................................................ Do.
ANDA 070528 ........ Furosemide Tablets USP, 80 mg .............................................................. Do.
ANDA 071238 ........ Doxepin Hydrochloride (HCl) Capsules USP, EQ 50 mg base ................ Do.
ANDA 071547 ........ Ibuprofen Tablets USP, 800 mg ............................................................... Do.
ANDA 072397 ........ Diazepam Injection USP, 5 mg/mL ........................................................... Do.
ANDA 072407 ........ Fenoprofen Calcium Tablets USP, EQ 600 mg base ............................... Do.
ANDA 072602 ........ Fenoprofen Calcium Tablets USP, EQ 600 mg base ............................... Do.
ANDA 072630 ........ Albuterol Tablets USP, EQ 4 mg base ..................................................... Do.
ANDA 072825 ........ Baclofen Tablets USP, 20 mg ................................................................... Do.
ANDA 073013 ........ Metaproterenol Sulfate Tablets USP, 10 mg ............................................ Do.
ANDA 073445 ........ Meperidine HCl Injection USP, 100 mg/mL .............................................. Do.
ANDA 074025 ........ Guanabenz Acetate Tablets USP, EQ 4 mg base and EQ 8 mg base ... Do.
ANDA 074114 ........ Dobutamine Injection USP, EQ 12.5 mg base/mL ................................... Do.
ANDA 074163 ........ Naproxen Tablets USP, 250 mg, 375 mg, and 500 mg ........................... Do.
ANDA 074287 ........ Piroxicam Capsules USP, 10 mg and 20 mg ........................................... Do.
ANDA 074303 ........ Pentamidine Isethionate for Injection, 300 mg/vial ................................... Do.
ANDA 074437 ........ Pindolol Tablets USP, 5 mg and 10 mg ................................................... Do.
asabaliauskas on DSKBBXCHB2PROD with NOTICES
ANDA 074456 ........ Alprazolam Tablets USP, 0.25 mg, 0.5 mg, and 1 mg ............................. Do.
ANDA 077643 ........ Topiramate Tablets USP, 25 mg, 50 mg, 100 mg, and 200 mg .............. Do.
ANDA 080728 ........ Diphenhydramine HCl Capsules USP, 25 mg .......................................... Do.
ANDA 080968 ........ Dexamethasone Tablets USP, 0.75 mg ................................................... Do.
ANDA 081040 ........ Chlorzoxazone Tablets USP, 500 mg ....................................................... Do.
ANDA 081149 ........ Hydroxyzine HCl Tablets USP, 10 mg ...................................................... Do.
ANDA 081189 ........ Hydrochlorothiazide Tablets USP, 25 mg ................................................. Do.
ANDA 081216 ........ Estropipate Tablets USP, 6 mg ................................................................ Do.
ANDA 083232 ........ Hydrochlorothiazide Tablets USP, 50 mg ................................................. Do.
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![Federal Register / Vol. 82, No. 204 / Tuesday, October 24, 2017 / Notices 49215
TABLE 1—Continued
Application No. Drug Applicant
ANDA 085720 ........ Meprobamate Tablets USP, 200 mg ........................................................ Do.
ANDA 085721 ........ Meprobamate Tablets USP, 400 mg ........................................................ Do.
ANDA 085778 ........ Hydroxyzine HCl Injection USP, 25 mg/mL .............................................. Do.
ANDA 086096 ........ Chlorpheniramine Maleate Injection USP, 10 mg/mL ............................... Do.
ANDA 086189 ........ Ergoloid Mesylates Sublingual Tablets USP, 0.5 mg ............................... Do.
ANDA 086598 ........ Nandrolone Decanoate Injection USP, 100 mg/mL .................................. Do.
ANDA 086795 ........ Chlorothiazide Tablets USP, 250 mg ........................................................ Do.
ANDA 087183 ........ Ergoloid Mesylates Sublingual Tablets USP, 1 mg .................................. Do.
ANDA 087296 ........ Chlorthalidone Tablets USP, 25 mg ......................................................... Do.
ANDA 087521 ........ Chlorthalidone Tablets USP, 50 mg ......................................................... Do.
ANDA 087772 ........ Prednisone Tablets USP, 50 mg .............................................................. Do.
ANDA 087979 ........ Chloroquine Phosphate Tablets USP, EQ 150 mg base ......................... Do.
ANDA 088030 ........ Chloroquine Phosphate Tablets USP, EQ 300 mg base ......................... Do.
ANDA 089042 ........ Procainamide HCl Extended-Release Tablets USP, 750 mg ................... Do.
Therefore, approval of the would constitute a clearly unwarranted confidential trade secrets or commercial
applications listed in table 1, and all invasion of personal privacy. property such as patentable material,
amendments and supplements thereto, Name of Committee: National Institute of and personal information concerning
is hereby withdrawn as of November 24, Allergy and Infectious Diseases Special individuals associated with the grant
2017. Introduction or delivery for Emphasis Panel; NIAID SBIR Phase II applications, the disclosure of which
introduction into interstate commerce of Clinical Trial Implementation Cooperative would constitute a clearly unwarranted
products without approved new drug Agreement (U44). invasion of personal privacy.
applications violates section 301(a) and Date: November 17, 2017.
Time: 1:00 p.m. to 4:00 p.m. Name of Committee: Center for Scientific
(d) of the Federal Food, Drug, and Review Special Emphasis Panel;
Agenda: To review and evaluate grant
Cosmetic Act (21 U.S.C. 331(a) and (d)). applications. International Research Ethics Training.
Drug products that are listed in table 1 Place: National Institutes of Health, 5601 Date: November 16, 2017.
that are in inventory on the date that Fishers Lane, Rockville, MD 20892 Time: 8:00 a.m. to 6:00 p.m.
this notice becomes effective (see the (Telephone Conference Call). Agenda: To review and evaluate grant
applications.
DATES section) may continue to be Contact Person: Vasundhara Varthakavi,
Place: National Institutes of Health, 6701
dispensed until the inventories have Ph.D., DVM, Scientific Review Officer,
Rockledge Drive, Bethesda, MD 20892.
been depleted or the drug products have Scientific Review Program, Division of
Contact Person: Karin F. Helmers, Ph.D.,
reached their expiration dates or Extramural Activities, Room 3E70, National
Scientific Review Officer, Center for
Institutes of Health, NIAID, 5601 Fishers
otherwise become violative, whichever Lane, MSC 9823, Bethesda, MD 20892–9823,
Scientific Review, National Institutes of
occurs first. Health, 6701 Rockledge Drive, Room 3148,
(240) 669–5020, varthakaviv@niaid.nih.gov.
MSC 7770, Bethesda, MD 20892, (301) 254–
Dated: October 18, 2017. (Catalogue of Federal Domestic Assistance 9975, helmersk@csr.nih.gov.
Leslie Kux, Program Nos. 93.855, Allergy, Immunology, Name of Committee: Center for Scientific
Associate Commissioner for Policy. and Transplantation Research; 93.856, Review Special Emphasis Panel; PAR16–121
Microbiology and Infectious Diseases Early-Stage Preclinical Validation of
[FR Doc. 2017–23046 Filed 10–23–17; 8:45 am]
Research, National Institutes of Health, HHS) Therapeutic Leads for Diseases of Interest to
BILLING CODE 4164–01–P
Dated: October 18, 2017. the NIDDK (R01).
Natasha M. Copeland, Date: November 16, 2017.
Time: 12:00 p.m. to 6:00 p.m.
DEPARTMENT OF HEALTH AND Program Analyst, Office of Federal Advisory
Agenda: To review and evaluate grant
HUMAN SERVICES Committee Policy.
applications.
[FR Doc. 2017–22967 Filed 10–23–17; 8:45 am] Place: National Institutes of Health, 6701
National Institutes of Health BILLING CODE 4140–01–P Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
National Institute of Allergy and Contact Person: Raul Rojas, Ph.D.,
Infectious Diseases; Notice of Closed DEPARTMENT OF HEALTH AND Scientific Review Officer, Center for
Meeting HUMAN SERVICES Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6185,
Pursuant to section 10(d) of the Bethesda, MD 20892, (301) 451–6319, rojasr@
Federal Advisory Committee Act, as National Institutes of Health
mail.nih.gov.
amended, notice is hereby given of the Name of Committee: Center for Scientific
Center for Scientific Review; Notice of
following meeting. Review Special Emphasis Panel; Member
The meeting will be closed to the Closed Meetings
Conflict: Macromolecular Structure and
public in accordance with the Pursuant to section 10(d) of the Function.
asabaliauskas on DSKBBXCHB2PROD with NOTICES
provisions set forth in sections Federal Advisory Committee Act, as Date: November 20, 2017.
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., amended, notice is hereby given of the Time: 1:00 p.m. to 6:00 p.m.
as amended. The grant applications and following meetings. Agenda: To review and evaluate grant
the discussions could disclose The meetings will be closed to the applications.
Place: National Institutes of Health, 6701
confidential trade secrets or commercial public in accordance with the Rockledge Drive, Bethesda, MD 20892
property such as patentable material, provisions set forth in sections (Telephone Conference Call).
and personal information concerning 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Contact Person: C-L Albert Wang, Ph.D.,
individuals associated with the grant as amended. The grant applications and Scientific Review Officer, Center for
applications, the disclosure of which the discussions could disclose Scientific Review, National Institutes of
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Document Created: 2018-10-25 10:11:00
Document Modified: 2018-10-25 10:11:00
| 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 24, 2017. | |
| 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. | |
| FR Citation | 82 FR 49214 |
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