Document ID: FDA-2019-N-5550-0001
Agency: fda
Document Type: Notice
Title: Elite Laboratories, Inc., et al.; Withdrawal of Approval of 23 Abbreviated New Drug Applications
Posted Date: 2020-01-08T05:00Z

[Federal Register Volume 85, Number 5 (Wednesday, January 8, 2020)]
[Notices]
[Pages 909-910]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-00076]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-5550]

Elite Laboratories, Inc., et al.; Withdrawal of Approval of 23 
Abbreviated New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is 
withdrawing approval of 23 abbreviated new drug applications (ANDAs) 
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approval of the applications be withdrawn.

DATES: Approval is withdrawn as of February 7, 2020.

FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 75, Rm. 1676, Silver Spring, MD 20993-0002, 240-
402-6980, Martha.Nguyen@fda.hhs.gov.

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.

------------------------------------------------------------------------
       Application No.                Drug                Applicant
------------------------------------------------------------------------
ANDA 040448.................  Phentermine           Elite Laboratories,
                               Hydrochloride (HCl)   Inc., 165 Ludlow
                               Capsules USP, 30      Ave., Northvale, NJ
                               milligrams (mg).      07647.
ANDA 060272.................  E-Mycin               Arbor
                               (erythromycin)        Pharmaceuticals,
                               Delayed-Release       LLC, 6 Concourse
                               Tablets USP, 250 mg   Parkway, Suite
                               and 333 mg.           1800, Atlanta, GA
                                                     30328.
ANDA 061639.................  E.E.S. 200             Do.
                               (erythromycin
                               ethylsuccinate) for
                               Oral Suspension,
                               Equivalent to (EQ)
                               200 mg base/5
                               milliliters
                               (mL).E.E.S. 400
                               (erythromycin
                               ethylsuccinate) for
                               Oral Suspension, EQ
                               400 mg base/5 mL.
ANDA 062290.................  EryDerm               Arbor
                               (erythromycin)        Pharmaceuticals,
                               Topical Solution      LLC.
                               USP, 2%.
ANDA 062304.................  Pediamycin             Do.
                               (erythromycin
                               ethylsuccinate)
                               Oral Suspension
                               USP, EQ 200 mg base/
                               5 mL Pediamycin 400
                               (erythromycin
                               ethylsuccinate)
                               Oral Suspension
                               USP, EQ 400 mg base/
                               5 mL.
ANDA 062659.................  Claforan ADD-Vantage  Sanofi-Aventis U.S.,
                               (cefotaxime) for      LLC, 55 Corporate
                               Injection USP, EQ 1   Dr., Bridgewater,
                               gram (g) base/vial    NJ 08807.
                               and EQ 2 g base/
                               vial.
ANDA 070347.................  Hydro-Ride            Par Pharmaceutical,
                               (amiloride HCl and    Inc., One Ram Ridge
                               hydrochlorothiazide   Rd., Spring Valley,
                               ) Tablets, EQ 5 mg    NY 10977.
                               Anhydrous/50 mg.
ANDA 071142.................  Clonidine HCl and      Do.
                               Chlorthalidone
                               Tablets USP, 0.3 mg/
                               15 mg.
ANDA 071178.................  Clonidine HCl and      Do.
                               Chlorthalidone
                               Tablets USP, 0.2 mg/
                               15 mg.
ANDA 071179.................  Clonidine HCl and      Do.
                               Chlorthalidone
                               Tablets USP, 0.1 mg/
                               15 mg.
ANDA 073191.................  Triamterene and       CASI
                               Hydrochlorothiazide   Pharmaceuticals,
                               Capsules USP, 50 mg/  Inc., c/o Target
                               25 mg.                Health, Inc., 261
                                                     Madison Ave., 24th
                                                     Floor, New York, NY
                                                     10016.
ANDA 073416.................  E-Z Scrub             Becton, Dickinson
                               (chlorhexidine        and Co., 9450 South
                               gluconate) Sponge,    State St., Sandy,
                               4%.                   UT 84070.
ANDA 076075.................  Econazole Nitrate     CASI
                               Cream, 1%.            Pharmaceuticals,
                                                     Inc., c/o Target
                                                     Health, Inc.
ANDA 076192.................  Ribavirin Capsules     Do.
                               USP, 200 mg.
ANDA 076514.................  Midodrine HCl          Do.
                               Tablets USP, 2.5
                               mg, 5 mg, and 10 mg.

[[Page 910]]

 
ANDA 078665.................  Next Choice           Foundation Consumer
                               (levonorgestrel)      Healthcare, LLC,
                               Tablets, 0.75 mg.     1190 Omega Dr.,
                                                     Pittsburgh, PA
                                                     15205.
ANDA 086809.................  Spironolactone        CASI
                               Tablets USP, 25 mg.   Pharmaceuticals,
                                                     Inc., c/o Target
                                                     Health, Inc.
ANDA 087143.................  Acetasol HC           Actavis Mid
                               (hydrocortisone and   Atlantic, LLC,
                               acetic acid) Otic     Subsidiary of Teva
                               Solution USP, 1%      Pharmaceuticals
                               and 2%.               USA, Inc., 425
                                                     Privet Rd.,
                                                     Horsham, PA 19044.
ANDA 088432.................  Meperidine HCl        ICU Medical, Inc.,
                               Injection USP, 10     600 North Field
                               mg/mL.                Dr., Lake Forest,
                                                     IL 60045.
ANDA 090288.................  Naratriptan Tablets   CASI
                               USP, EQ 1 mg base     Pharmaceuticals,
                               and EQ 2.5 mg base.   Inc., c/o Target
                                                     Health, Inc.
ANDA 091597.................  Gemcitabine for       Sagent
                               Injection USP, EQ     Pharmaceuticals,
                               200 mg base/vial      Inc., 1901 North
                               and EQ 1 g base/      Roselle Rd.,
                               vial.                 Schaumburg, IL
                                                     60195.
ANDA 200670.................  Next Choice One Dose  Foundation Consumer
                               (levonorgestrel)      Healthcare, LLC.
                               Tablets, 1.5 mg.
ANDA 203384.................  Epinastine HCl        CASI
                               Ophthalmic            Pharmaceuticals,
                               Solution, 0.05%.      Inc., c/o Target
                                                     Health, Inc.
------------------------------------------------------------------------

    Therefore, approval of the applications listed in the table, and 
all amendments and supplements thereto, is hereby withdrawn as of 
February 7, 2020. Approval of each entire application is withdrawn, 
including any strengths or products inadvertently missing from the 
table. 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 February 7, 2020 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: January 2, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-00076 Filed 1-7-20; 8:45 am]
BILLING CODE 4164-01-P