[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applications be withdrawn.
DATES: Approval is withdrawn as of May 1, 2019.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]]
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Application No. Drug Applicant
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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.
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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