Document ID: FDA-2019-N-0598-0001
Agency: fda
Document Type: Notice
Title: Teva Women’s Health, Inc., et al.; Withdrawal of Approval of 16 New Drug Applications
Posted Date: 2019-04-01T04:00Z

[Federal Register Volume 84, Number 62 (Monday, April 1, 2019)]
[Notices]
[Pages 12262-12263]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06237]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-0598]

Teva Women's Health, Inc., et al.; Withdrawal of Approval of 16 
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 16 new drug applications (NDAs) 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applications be withdrawn.

DATES: Approval is withdrawn as of May 1, 2019.

FOR FURTHER INFORMATION CONTACT: Kimberly Lehrfeld, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993-0002, 301-
796-3137.

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 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.

[[Page 12263]]

------------------------------------------------------------------------
      Application No.                Drug                Applicant
------------------------------------------------------------------------
NDA 007883................  Antabuse (disulfiram)  Teva Women's Health,
                             Tablets, 250           Inc., 41 Moores Rd.,
                             milligrams (mg) and    P.O. Box 4011,
                             500 mg.                Frazer, PA 19355.
NDA 011324................  Sinografin             Bracco Diagnostic
                             (diatrizoate           Inc., 259 Prospect
                             meglumine and          Plains Rd., Bldg. H,
                             iodipadmide            Monroe Township, NJ
                             meglumine)             08831.
                             Injection, 52.7%/
                             26.8%.
NDA 018932................  ReVia (naltrexone      Teva Women's Health,
                             hydrochloride)         Inc.
                             Tablets, 50 mg.
NDA 019880................  Paraplatin             Corden Pharma Latina
                             (carboplatin)          S.p.A., c/o
                             Injection, 50 mg/      Clinipace, Inc.,
                             vial, 150 mg/vial,     4840 Pearl East
                             and 450 mg/vial.       Circle, Suite 201E,
                                                    Boulder, CO 80301.
NDA 020261................  Lescol (fluvastatin    Novartis
                             sodium) Capsules, 20   Pharmaceuticals
                             mg and 40 mg.          Corp., One Health
                                                    Plaza, East Hanover,
                                                    NJ 07936-1080.
NDA 020452................  Paraplatin             Corden Pharma Latina
                             (carboplatin)          S.p.A.
                             Injection in
                             multiple dose vials,
                             50 mg/5 milliliters
                             (mL), 150 mg/15 mL,
                             450 mg/45 mL, and
                             600 mg/60 mL.
NDA 021431................  Campral (acamprosate   Allergan Sales, LLC.,
                             calcium) Delayed-      5 Giralda Farms,
                             Release Tablets, 333   Madison, NJ 07940.
                             mg.
NDA 021551................  Halflytely and         Braintree
                             Bisacodyl Tablet       Laboratories, Inc.,
                             Bowel Prep Kit         60 Columbian St.
                             (polyethylene glycol   West, P.O. Box
                             3350, potassium        850929, Braintree,
                             chloride, sodium       MA 02185.
                             bicarbonate, and
                             sodium chloride
                             powder for oral
                             solution, 210 grams
                             (g)/0.74 g/2.86 g/
                             5.6 g; bisacodyl
                             delayed-release
                             tablet, 5 mg).
NDA 021823................  Actonel with Calcium   Warner Chilcott Co.,
                             (risedronate sodium    LLC., 100 Enterprise
                             tablets, 35 mg;        Dr., Rockaway, NJ
                             calcium carbonate      07866.
                             tablets USP,
                             equivalent to 500 mg
                             base).
NDA 021905................  Valtropine             LG Chem, Ltd., c/o
                             (somatropin) for       Parexel
                             Injection, 5 mg/vial.  International, LLC.,
                                                    4600 East-West
                                                    Highway, Suite 350,
                                                    Bethesda, MD 20814.
NDA 022396................  Dyloject (diclofenac   Javelin
                             sodium) Injection,     Pharmaceuticals,
                             37.5 mg/mL.            Inc., c/o Hospira,
                                                    Inc., 275 North
                                                    Field Dr., Dept.
                                                    0389, HI-3S, Lake
                                                    Forest, IL 60045.
NDA 050619................  Mycostatin (nystatin)  Delcor Asset Corp., c/
                             Pastilles, 200,000     o Mylan, Inc., 781
                             Units.                 Chestnut Ridge Rd.,
                                                    P.O. Box 4310,
                                                    Morgantown, WV 26504-
                                                    4310.
NDA 050739................  Omnicef (cefdinir)     AbbVie Inc., 1 North
                             Capsules, 300 mg.      Waukegan Rd., North
                                                    Chicago, IL 60064.
NDA 050749................  Omnicef (cefdinir)     Do.
                             Oral Suspension, 125
                             mg/5 mL and 250 mg/5
                             mL.
NDA 050757................  PrevPAC (amoxicillin   Takeda
                             capsules USP, 500      Pharmaceuticals
                             mg; clarithromycin     U.S.A., Inc., One
                             tablets USP, 500 mg;   Takeda Parkway,
                             and lansoprazole       Deerfield, IL 60015.
                             delayed-release
                             capsules, 30 mg).
NDA 202356................  Docetaxel Injection,   Pfizer Inc., 235 East
                             20 mg/2 mL, 80 mg/8    42nd St., New York,
                             mL, 130 mg/13 mL,      NY 10017.
                             and 200 mg/20 mL.
------------------------------------------------------------------------

    Therefore, approval of the applications listed in the table, and 
all amendments and supplements thereto, is hereby withdrawn as of May 
1, 2019. The drug product strengths listed in the table include all 
strengths FDA has identified as being previously approved under these 
NDAs. In each case, approval of the entire application is withdrawn, 
including any strengths 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 May 1, 2019 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: March 26, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-06237 Filed 3-29-19; 8:45 am]
 BILLING CODE 4164-01-P