83_FR_39255 83 FR 39102 - Fougera Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 27 Abbreviated New Drug Applications

83 FR 39102 - Fougera Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 27 Abbreviated New Drug Applications

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 153 (August 8, 2018)

Page Range39102-39103
FR Document2018-16985

The Food and Drug Administration (FDA or Agency) is withdrawing approval of 27 abbreviated 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

Federal Register, Volume 83 Issue 153 (Wednesday, August 8, 2018) 
[Federal Register Volume 83, Number 153 (Wednesday, August 8, 2018)]
[Notices]
[Pages 39102-39103]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-16985]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-2485]


Fougera Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 
27 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 27 abbreviated 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requested that the approval of the applications be withdrawn.

DATES: Approval is withdrawn as of September 7, 2018.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, 
[email protected].

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 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.

------------------------------------------------------------------------
        Application No.                  Drug               Applicant
------------------------------------------------------------------------
ANDA 061467...................  Pyocidin-Otic           Fougera
                                 (hydrocortisone and     Pharmaceuticals
                                 polymyxin B sulfate)    , Inc., 60
                                 Otic Solution, 5        Baylis Rd.,
                                 milligrams (mg)/        P.O. Box 2006,
                                 10,000 units per        Melville, NY
                                 milliliter (mL).        11747.
ANDA 061653...................  Tetrex (tetracycline    Bristol-Myers
                                 phosphate complex)      Squibb Co.,
                                 Capsules, Equivalent    P.O. Box 4000,
                                 to (EQ) 100 mg          Princeton, NJ
                                 Hydrochloride (HCl),    08543.
                                 EQ 250 mg HCl and EQ
                                 500 mg HCl.
ANDA 061658...................  Bristacycline           Do.
                                 (tetracycline HCl)
                                 Capsules, 250 mg and
                                 500 mg.
ANDA 061711...................  Penicillin V Potassium  Do.
                                 Tablets.
ANDA 061721...................  Ampicillin Capsules,    Do.
                                 250 mg and 500 mg.
ANDA 061726...................  Azotrex                 Do.
                                 (phenazopyridine HCl,
                                 sulfamethizole and
                                 tetracycline
                                 phosphate complex)
                                 Capsules, 50 mg/250
                                 mg/125 mg.
ANDA 061790...................  Hetacillin Potassium..  Do.
ANDA 061887...................  Bristamycin             Do.
                                 (erythromycin
                                 stearate) Tablets, EQ
                                 250 mg base.
ANDA 061888...................  Bristacycline           Do.
                                 (tetracycline HCl)
                                 Capsules, 250 mg and
                                 500 mg.
ANDA 061889...................  Tetrex (tetracycline    Do.
                                 phosphate complex)
                                 Capsules, EQ 250 mg
                                 HCl and EQ 500 mg HCl.
ANDA 061890...................  Azotrex                 Do.
                                 (phenazopyridine HCl,
                                 sulfamethizole, and
                                 tetracycline)
                                 Capsules, 50 mg/250
                                 mg/125 mg.
ANDA 061891...................  Tetrex-S                Do.
                                 (tetracycline) Syrup,
                                 125 mg/5 mL.
ANDA 061975...................  Cephradine Powder for   Do.
                                 Injection.
ANDA 062168...................  Cephradine Tablets....  Do.
ANDA 062259...................  Amphotericin B for Use  Do.
                                 in Parenteral
                                 Products.
ANDA 062543...................  Mycolog (nystatin,      Do.
                                 neomycin sulfate,
                                 gramicidin, and
                                 triamcinolone
                                 acetonide) Ointment.
ANDA 071793...................  Foamcoat (aluminum      Guardian Drug
                                 hydroxide; magnesium    Co., 2 Charles
                                 trisilicate) Chewable   Court, Dayton,
                                 Tablets, 80 mg/20 mg    NJ 08810.
                                 (OTC).
ANDA 072035...................  Nuprin (ibuprofen)      Bristol-Myers
                                 Tablets, 200 mg.        Squibb Co.
ANDA 072036...................  Nuprin (ibuprofen)      Do.
                                 Tablets, 200 mg.
ANDA 074911...................  Phrenilin with          Valeant
                                 Caffeine and Codeine    Pharmaceuticals
                                 (acetaminophen,         North America,
                                 butalbital, caffeine,   LLC, 400
                                 and codeine             Somerset
                                 phosphate) Capsules,    Corporate
                                 325 mg/50 mg/40 mg/30   Blvd.,
                                 mg.                     Bridgewater, NJ
                                                         08807.
ANDA 074944...................  Atracurium Besylate     Watson
                                 Injection, 10 mg/mL.    Laboratories,
                                                         Inc.,
                                                         Subsidiary of
                                                         Teva
                                                         Pharmaceuticals
                                                         USA, Inc., 425
                                                         Privet Rd.,
                                                         Horsham, PA
                                                         19044.
ANDA 075206...................  Cytosar-U (cytarabine)  Teva
                                 for Injection USP,      Pharmaceuticals
                                 100 mg/vial, 500 mg/    USA, Inc., 425
                                 vial, 1 gram (g)/       Privet Rd.,
                                 vial, and 2 g/vial.     Horsham, PA
                                                         19044.
ANDA 077337...................  Rosiglitazone Maleate   Do.
                                 and Metformin HCl
                                 Tablets, EQ 1 mg base/
                                 500 mg, EQ 2 mg base/
                                 500 mg, EQ 4 mg base/
                                 500 mg, EQ 2 mg base/
                                 1 g, and EQ 4 mg base/
                                 1 g.
ANDA 077930...................  Meloxicam Tablets, 7.5  Impax
                                 mg and 15 mg.           Laboratories,
                                                         Inc., 30831
                                                         Huntwood Ave.,
                                                         Hayward, CA
                                                         94544.
ANDA 080658...................  Procaine HCl            Watson
                                 Injection, 1% and 2%.   Laboratories,
                                                         Inc.,
                                                         Subsidiary of
                                                         Teva
                                                         Pharmaceuticals
                                                         USA, Inc.
ANDA 083128...................  Hydrocortisone Acetate  Do.
                                 Injectable
                                 Suspension, 25 mg/mL.
ANDA 090181...................  Ifosfamide for          Fresenius Kabi
                                 Injection, 1 g/20 mL    USA, LLC, Three
                                 and 3 g/60 mL.          Corporate Dr.,
                                                         Lake Zurich, IL
                                                         60047.
------------------------------------------------------------------------


[[Page 39103]]

    Therefore, approval of the applications listed in the table, and 
all amendments and supplements thereto, is hereby withdrawn as of 
September 7, 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 September 7, 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: August 3, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-16985 Filed 8-7-18; 8:45 am]
BILLING CODE 4164-01-P

39102 Federal Register / Vol. 83, No. 153 / Wednesday, August 8, 2018 / Notices Jeffrey M. Zirger, ACTION: Notice. SUPPLEMENTARY INFORMATION: The Acting Chief, Information Collection Review holders of the applications listed in the Office, Office of Scientific Integrity, Office SUMMARY: The Food and Drug table have informed FDA that these drug of the Associate Director for Science, Office Administration (FDA or Agency) is products are no longer marketed and of the Director, Centers for Disease Control withdrawing approval of 27 abbreviated and Prevention. new drug applications (ANDAs) from have requested that FDA withdraw [FR Doc. 2018–16947 Filed 8–7–18; 8:45 am] multiple applicants. The holders of the approval of the applications under the applications notified the Agency in process described in § 314.150(c) (21 BILLING CODE 4163–18–P writing that the drug products were no CFR 314.150(c)). The applicants have longer marketed and requested that the also, by their requests, waived their DEPARTMENT OF HEALTH AND approval of the applications be opportunity for a hearing. Withdrawal HUMAN SERVICES withdrawn. of approval of an application or abbreviated application under DATES: Approval is withdrawn as of Food and Drug Administration § 314.150(c) is without prejudice to September 7, 2018. [Docket No. FDA–2018–N–2485] refiling. FOR FURTHER INFORMATION CONTACT: Trang Tran, Center for Drug Evaluation Fougera Pharmaceuticals, Inc., et al.; and Research, Food and Drug Withdrawal of Approval of 27 Administration, 10903 New Hampshire Abbreviated New Drug Applications Ave., Bldg. 75, Rm. 1671, Silver Spring, AGENCY: Food and Drug Administration, MD 20993–0002, 240–402–7945, HHS. Trang.Tran@fda.hhs.gov. Application No. Drug Applicant ANDA 061467 ......... Pyocidin-Otic (hydrocortisone and polymyxin B sulfate) Otic Solution, 5 milli- Fougera Pharmaceuticals, Inc., 60 grams (mg)/10,000 units per milliliter (mL). Baylis Rd., P.O. Box 2006, Melville, NY 11747. ANDA 061653 ......... Tetrex (tetracycline phosphate complex) Capsules, Equivalent to (EQ) 100 mg Bristol-Myers Squibb Co., P.O. Box Hydrochloride (HCl), EQ 250 mg HCl and EQ 500 mg HCl. 4000, Princeton, NJ 08543. ANDA 061658 ......... Bristacycline (tetracycline HCl) Capsules, 250 mg and 500 mg ........................... Do. ANDA 061711 ......... Penicillin V Potassium Tablets .............................................................................. Do. ANDA 061721 ......... Ampicillin Capsules, 250 mg and 500 mg ............................................................. Do. ANDA 061726 ......... Azotrex (phenazopyridine HCl, sulfamethizole and tetracycline phosphate com- Do. plex) Capsules, 50 mg/250 mg/125 mg. ANDA 061790 ......... Hetacillin Potassium ............................................................................................... Do. ANDA 061887 ......... Bristamycin (erythromycin stearate) Tablets, EQ 250 mg base ........................... Do. ANDA 061888 ......... Bristacycline (tetracycline HCl) Capsules, 250 mg and 500 mg ........................... Do. ANDA 061889 ......... Tetrex (tetracycline phosphate complex) Capsules, EQ 250 mg HCl and EQ Do. 500 mg HCl. ANDA 061890 ......... Azotrex (phenazopyridine HCl, sulfamethizole, and tetracycline) Capsules, 50 Do. mg/250 mg/125 mg. ANDA 061891 ......... Tetrex-S (tetracycline) Syrup, 125 mg/5 mL ......................................................... Do. ANDA 061975 ......... Cephradine Powder for Injection ........................................................................... Do. ANDA 062168 ......... Cephradine Tablets ................................................................................................ Do. ANDA 062259 ......... Amphotericin B for Use in Parenteral Products .................................................... Do. ANDA 062543 ......... Mycolog (nystatin, neomycin sulfate, gramicidin, and triamcinolone acetonide) Do. Ointment. ANDA 071793 ......... Foamcoat (aluminum hydroxide; magnesium trisilicate) Chewable Tablets, 80 Guardian Drug Co., 2 Charles Court, mg/20 mg (OTC). Dayton, NJ 08810. ANDA 072035 ......... Nuprin (ibuprofen) Tablets, 200 mg ....................................................................... Bristol-Myers Squibb Co. ANDA 072036 ......... Nuprin (ibuprofen) Tablets, 200 mg ....................................................................... Do. ANDA 074911 ......... Phrenilin with Caffeine and Codeine (acetaminophen, butalbital, caffeine, and Valeant Pharmaceuticals North Amer- codeine phosphate) Capsules, 325 mg/50 mg/40 mg/30 mg. ica, LLC, 400 Somerset Corporate Blvd., Bridgewater, NJ 08807. ANDA 074944 ......... Atracurium Besylate Injection, 10 mg/mL .............................................................. Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044. ANDA 075206 ......... Cytosar-U (cytarabine) for Injection USP, 100 mg/vial, 500 mg/vial, 1 gram (g)/ Teva Pharmaceuticals USA, Inc., 425 vial, and 2 g/vial. Privet Rd., Horsham, PA 19044. ANDA 077337 ......... Rosiglitazone Maleate and Metformin HCl Tablets, EQ 1 mg base/500 mg, EQ Do. 2 mg base/500 mg, EQ 4 mg base/500 mg, EQ 2 mg base/1 g, and EQ 4 mg base/1 g. ANDA 077930 ......... Meloxicam Tablets, 7.5 mg and 15 mg ................................................................. Impax Laboratories, Inc., 30831 Huntwood Ave., Hayward, CA 94544. ANDA 080658 ......... Procaine HCl Injection, 1% and 2% ...................................................................... Watson Laboratories, Inc., Subsidiary sradovich on DSK3GMQ082PROD with NOTICES of Teva Pharmaceuticals USA, Inc. ANDA 083128 ......... Hydrocortisone Acetate Injectable Suspension, 25 mg/mL ................................... Do. ANDA 090181 ......... Ifosfamide for Injection, 1 g/20 mL and 3 g/60 mL ............................................... Fresenius Kabi USA, LLC, Three Cor- porate Dr., Lake Zurich, IL 60047. VerDate Sep<11>2014 22:37 Aug 07, 2018 Jkt 244001 PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 E:\FR\FM\08AUN1.SGM 08AUN1

Federal Register / Vol. 83, No. 153 / Wednesday, August 8, 2018 / Notices 39103 Therefore, approval of the DEPARTMENT OF HEALTH AND DATES:Approval is withdrawn as of applications listed in the table, and all HUMAN SERVICES September 7, 2018. amendments and supplements thereto, FOR FURTHER INFORMATION CONTACT: is hereby withdrawn as of September 7, Food and Drug Administration Florine P. Purdie, Center for Drug 2018. Introduction or delivery for [Docket No. FDA–2018–N–2702] Evaluation and Research, Food and introduction into interstate commerce of Drug Administration, 10903 New products without approved new drug Merck Sharp & Dohme Corporation, et Hampshire Ave., Bldg. 51, Rm. 6248, applications violates section 301(a) and al.; Withdrawal of Approval of Four Silver Spring, MD 20993–0002, 301– (d) of the Federal Food, Drug, and New Drug Applications 796–3601. Cosmetic Act (21 U.S.C. 331(a) and (d)). AGENCY: Food and Drug Administration, SUPPLEMENTARY INFORMATION: The Drug products that are listed in the table holders of the applications listed in the HHS. that are in inventory on September 7, table have informed FDA that these drug 2018 may continue to be dispensed ACTION: Notice. products are no longer marketed and until the inventories have been depleted SUMMARY: The Food and Drug have requested that FDA withdraw or the drug products have reached their Administration (FDA or Agency) is approval of the applications under the expiration dates or otherwise become withdrawing approval of four new drug process described in § 314.150(c) (21 violative, whichever occurs first. applications (NDAs) from multiple CFR 314.150(c)). The applicants have Dated: August 3, 2018. applicants. The holders of the also, by their requests, waived their Leslie Kux, applications notified the Agency in opportunity for a hearing. Withdrawal writing that the drug products were no of approval of an application or Associate Commissioner for Policy. longer marketed and requested that the abbreviated application under [FR Doc. 2018–16985 Filed 8–7–18; 8:45 am] approval of the applications be § 314.150(c) is without prejudice to BILLING CODE 4164–01–P withdrawn. refiling. Application No. Drug Applicant NDA 005619 ............ Aminohippurate Sodium (PAH) 20% sterile solution Injec- Merck Sharp & Dohme Corp., Subsidiary of Merck & Com- tion, 2 grams in 10 milliliter (mL) vials. pany, Inc., 1 Merck Dr., P.O. Box 100, Whitehouse Sta- tion, NJ 08889. NDA 008506 ............ Hydrocortone (hydrocortisone) Tablets USP, 10 milligrams Do. (mg) and 20 mg. NDA 011891 ............ Durabolin (nandrolone phenpropionate) Injection, 25 mg/mL Organon USA, Inc., Subsidiary of Merck & Company, Inc., and 50 mg/mL. 2000 Galloping Hill Rd., Kenilworth, NJ 07033. NDA 020301 ............ Ortho-Cept (desogestrel and ethinyl estradiol) Tablets USP, Janssen Pharmaceuticals, Inc., 920 U.S. Hwy. 202, P.O. 0.15 mg/0.03 mg (21-Day and 28-Day Regimens). Box 300, Raritan, NJ 08869–0602. Therefore, approval of the DEPARTMENT OF HEALTH AND (USP) requirement for the control of applications listed in the table, and all HUMAN SERVICES elemental impurities. amendments and supplements thereto, DATES: The announcement of the is hereby withdrawn as of September 7, Food and Drug Administration guidance is published in the Federal 2018. Introduction or delivery for [Docket No. FDA–2016–D–1692] Register on August 8, 2018. introduction into interstate commerce of ADDRESSES: You may submit either products without approved new drug Elemental Impurities in Drug Products; electronic or written comments on applications violates section 301(a) and Guidance for Industry; Availability Agency guidances at any time as (d) of the Federal Food, Drug, and AGENCY: Food and Drug Administration, follows: Cosmetic Act (21 U.S.C. 331(a) and (d)). HHS. Electronic Submissions Drug products that are listed in the table ACTION: Notice of availability. that are in inventory on September 7, Submit electronic comments in the 2018 may continue to be dispensed SUMMARY: The Food and Drug following way: until the inventories have been depleted Administration (FDA or Agency) is • Federal eRulemaking Portal: or the drug products have reached their announcing the availability of a final https://www.regulations.gov. Follow the expiration dates or otherwise become guidance for industry entitled instructions for submitting comments. violative, whichever occurs first. ‘‘Elemental Impurities in Drug Comments submitted electronically, Products.’’ This guidance finalizes the including attachments, to https:// Dated: August 3, 2018. draft guidance issued July 1, 2016, www.regulations.gov will be posted to Leslie Kux, which provides recommendations the docket unchanged. Because your Associate Commissioner for Policy. regarding the control of elemental comment will be made public, you are [FR Doc. 2018–16982 Filed 8–7–18; 8:45 am] impurities of human drug products solely responsible for ensuring that your BILLING CODE 4164–01–P marketed in the United States consistent comment does not include any with the implementation of confidential information that you or a sradovich on DSK3GMQ082PROD with NOTICES International Council for Harmonisation third party may not wish to be posted, (ICH) guidance for industry entitled such as medical information, your or ‘‘Q3D Elemental Impurities’’ (ICH Q3D). anyone else’s Social Security number, or This guidance will also assist confidential business information, such manufacturers of compendial drug as a manufacturing process. Please note products in responding to the issuance that if you include your name, contact of the United States Pharmacopeia information, or other information that VerDate Sep<11>2014 22:37 Aug 07, 2018 Jkt 244001 PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 E:\FR\FM\08AUN1.SGM 08AUN1


Document Created: 2018-08-08 02:06:01
Document Modified: 2018-08-08 02:06:01
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesApproval is withdrawn as of September 7, 2018.
ContactTrang 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 Citation83 FR 39102 
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