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

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 Ag...

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Department of Health and Human Services
Food and Drug Administration
  1. [Docket No. FDA-2019-N-5550]

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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Approval is withdrawn as of February 7, 2020.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, .

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 § 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 § 314.150(c) is without prejudice to refiling.

Application No. Drug Applicant
ANDA 040448 Phentermine Hydrochloride (HCl) Capsules USP, 30 milligrams (mg) Elite Laboratories, Inc., 165 Ludlow Ave., Northvale, NJ 07647.
ANDA 060272 E-Mycin (erythromycin) Delayed-Release Tablets USP, 250 mg and 333 mg Arbor Pharmaceuticals, LLC, 6 Concourse Parkway, Suite 1800, Atlanta, GA 30328.
ANDA 061639 E.E.S. 200 (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   Do.
ANDA 062290 EryDerm (erythromycin) Topical Solution USP, 2% Arbor Pharmaceuticals, LLC.
ANDA 062304 Pediamycin (erythromycin ethylsuccinate) Oral Suspension USP, EQ 200 mg base/5 mL Pediamycin 400 (erythromycin ethylsuccinate) Oral Suspension USP, EQ 400 mg base/5 mL   Do.
ANDA 062659 Claforan ADD-Vantage (cefotaxime) for Injection USP, EQ 1 gram (g) base/vial and EQ 2 g base/vial Sanofi-Aventis U.S., LLC, 55 Corporate Dr., Bridgewater, NJ 08807.
ANDA 070347 Hydro-Ride (amiloride HCl and hydrochlorothiazide) Tablets, EQ 5 mg Anhydrous/50 mg Par Pharmaceutical, Inc., One Ram Ridge Rd., Spring Valley, NY 10977.
ANDA 071142 Clonidine HCl and Chlorthalidone Tablets USP, 0.3 mg/15 mg   Do.
ANDA 071178 Clonidine HCl and Chlorthalidone Tablets USP, 0.2 mg/15 mg   Do.
ANDA 071179 Clonidine HCl and Chlorthalidone Tablets USP, 0.1 mg/15 mg   Do.
ANDA 073191 Triamterene and Hydrochlorothiazide Capsules USP, 50 mg/25 mg CASI Pharmaceuticals, Inc., c/o Target Health, Inc., 261 Madison Ave., 24th Floor, New York, NY 10016.
ANDA 073416 E-Z Scrub (chlorhexidine gluconate) Sponge, 4% Becton, Dickinson and Co., 9450 South State St., Sandy, UT 84070.
ANDA 076075 Econazole Nitrate Cream, 1% CASI Pharmaceuticals, Inc., c/o Target Health, Inc.
ANDA 076192 Ribavirin Capsules USP, 200 mg   Do.
ANDA 076514 Midodrine HCl Tablets USP, 2.5 mg, 5 mg, and 10 mg   Do.
( printed page 910)
ANDA 078665 Next Choice (levonorgestrel) Tablets, 0.75 mg Foundation Consumer Healthcare, LLC, 1190 Omega Dr., Pittsburgh, PA 15205.
ANDA 086809 Spironolactone Tablets USP, 25 mg CASI Pharmaceuticals, Inc., c/o Target Health, Inc.
ANDA 087143 Acetasol HC (hydrocortisone and acetic acid) Otic Solution USP, 1% and 2% Actavis Mid Atlantic, LLC, Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044.
ANDA 088432 Meperidine HCl Injection USP, 10 mg/mL ICU Medical, Inc., 600 North Field Dr., Lake Forest, IL 60045.
ANDA 090288 Naratriptan Tablets USP, EQ 1 mg base and EQ 2.5 mg base CASI Pharmaceuticals, Inc., c/o Target Health, Inc.
ANDA 091597 Gemcitabine for Injection USP, EQ 200 mg base/vial and EQ 1 g base/vial Sagent Pharmaceuticals, Inc., 1901 North Roselle Rd., Schaumburg, IL 60195.
ANDA 200670 Next Choice One Dose (levonorgestrel) Tablets, 1.5 mg Foundation Consumer Healthcare, LLC.
ANDA 203384 Epinastine HCl Ophthalmic Solution, 0.05% CASI Pharmaceuticals, 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

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“Elite Laboratories, Inc., et al.; Withdrawal of Approval of 23 Abbreviated New Drug Applications,” thefederalregister.org (January 8, 2020), https://thefederalregister.org/documents/2020-00076/elite-laboratories-inc-et-al-withdrawal-of-approval-of-23-abbreviated-new-drug-applications.