Delcor Asset Corp. et al.; Withdrawal of Approval of 22 Abbreviated New Drug Applications
Federal Register, Volume 83 Issue 11 (Wednesday, January 17, 2018)
Federal Register Volume 83, Number 11 (Wednesday, January 17, 2018)
Notices
Pages 2455-2456
From the Federal Register Online via the Government Publishing Office www.gpo.gov
FR Doc No: 2018-00695
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2017-N-0002
Delcor Asset Corp. et al.; Withdrawal of Approval of 22 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 22 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
DATES: Approval is withdrawn as of February 16, 2018.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 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 application or abbreviated application under Sec. 314.150(c) is without prejudice to refiling.
Table 1--ANDAs for Which FDA Is Withdrawing Approval
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Application No. Drug Applicant
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ANDA 060577........................ Mycostatin (nystatin) Vaginal Delcor Asset Corp., 411 South State
Tablets, 100,000 units. St., Suite E-100, Newtown, PA
18940.
ANDA 063302........................ Cefamandole Nafate for Injection..... ACS Dobfar SpA, c/o Interchem Corp.,
120 Route 17 North, Paramus, NJ
07653.
ANDA 070462........................ Diazepam Tablets USP, 2 milligrams Virtus Pharmaceuticals, 12 Penns
(mg). Trail, Newtown, PA 18940.
ANDA 070463........................ Diazepam Tablets USP, 5 mg........... Do.
ANDA 070998........................ Potassium Chloride Extended-Release Future Pak, Ltd., 28115 Lakeview
Tablets, 8 milliequivalents (mEq). Dr., Wixom, MI 48393.
ANDA 070999........................ Potassium Chloride Extended-Release Do.
Tablets, 10 mEq.
Page 2456
ANDA 075375........................ Diltiazem Hydrochloride (HCl) Mylan Laboratories, Ltd., c/o Mylan
Injection, 5 mg/milliliter (mL). Pharmaceuticals, Inc., 781 Chestnut
Ridge Rd., P.O. Box 4310,
Morgantown, WV 26504.
ANDA 076911........................ Clorazepate Dipotassium Tablets USP, Sun Pharmaceutical Industries, Ltd.,
3.75 mg, 7.5 mg, and 15 mg. c/o Sun Pharmaceutical Industries,
Inc., 2 Independence Way,
Princeton, NJ 08540.
ANDA 077102........................ Calcitriol Injection, 0.001 mg/mL.... Sagent Pharmaceuticals, Inc., 1901
N. Roselle Rd., Suite 450,
Schaumburg, IL 60195.
ANDA 084656........................ Acetaminophen and Codeine Phosphate Roxane Laboratories, Inc., 1809
Tablets USP, 300 mg/30 mg. Wilson Rd., Columbus, OH 43228.
ANDA 087977........................ Diphenhydramine HCl Capsules, 25 mg.. LNK International, Inc., 145
Ricefield Ln., Hauppauge, NY 11788.
ANDA 088676........................ Methylprednisolone Sodium Succinate LyphoMed, Division of Fujisawa USA,
for Injection USP, Equivalent to 40 Inc., 2045 North Cornell Ave.,
mg base/vial. Melrose Park, IL 60160.
ANDA 089080........................ Acetaminophen and Codeine Phosphate Purepac Pharmaceutical Co., 200
Tablets USP, 300 mg/30 mg. Elmora Ave., Elizabeth, NJ 07207.
ANDA 089183........................ Acetaminophen and Codeine Phosphate Superpharm Corp., 1769 Fifth Ave.,
Tablets USP, 300 mg/15 mg. Bayshore, NY 11706.
ANDA 089253........................ Acetaminophen and Codeine Phosphate Do.
Tablets USP, 300 mg/30 mg.
ANDA 089219........................ Procainamide HCl Capsules USP, 250 IDT Australia, Ltd., c/o Facet Life
mg, 375 mg, and 500 mg. Sciences, Inc., 6122 Stone Wolfe
Dr., Glen Carbon, IL 62034.
ANDA 089254........................ Acetaminophen and Codeine Phosphate Do.
Tablets USP, 300 mg/60 mg.
ANDA 089369........................ Procainamide HCl Extended-Release Do.
Tablets USP, 250 mg, 500 mg, and 750
mg.
ANDA 089481........................ Acetaminophen and Codeine Phosphate American Therapeutics, Inc., 75
Tablets USP, 300 mg/15 mg. Carlough Rd., Bohemia, NY 11716.
ANDA 089482........................ Acetaminophen and Codeine Phosphate Do.
Tablets USP, 300 mg/30 mg.
ANDA 089483........................ Acetaminophen and Codeine Phosphate Do.
Tablets USP, 300 mg/60 mg.
ANDA 206711........................ Olanzapine Tablets USP, 2.5 mg, 5 mg, Ajanta Pharma, Ltd., c/o Ajanta
7.5 mg, 10 mg, 15 mg, and 20 mg. Pharma USA, Inc., One Grande
Commons, 440 U.S. Highway 22 East,
Suite 150, Bridgewater, NJ 08807.
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Therefore, approval of the applications listed in table 1, and all amendments and supplements thereto, is hereby withdrawn as of February 16, 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 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: January 11, 2018.
Leslie Kux,
Associate Commissioner for Policy.
FR Doc. 2018-00695 Filed 1-16-18; 8:45 am
BILLING CODE 4164-01-P
