[Federal Register Volume 84, Number 128 (Wednesday, July 3, 2019)]
[Notices]
[Pages 31872-31873]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-14219]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-2040]
Liebel-Flarsheim Company LLC, et al.; Withdrawal of Approval of
11 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 11 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applications be withdrawn.
DATES: Approval is withdrawn as of August 2, 2019.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.
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Application No. Drug Applicant
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NDA 016983................ Conray 30 Liebel-Flarsheim Co.
(iothalamate LLC, 1034 South
meglumine) Brentwood Blvd.,
Injection, 30%. Suite 800, Richmond
Heights, MO 63117.
NDA 018972................ Cordarone (amiodarone Wyeth Pharmaceuticals
HCl) Tablets, 200 mg. LLC, P.O. Box 8299,
Philadelphia, PA
19101-8299.
NDA 019009................ Maxair Inhaler Bausch Health US,
(pirbuterol acetate LLC, 400 Somerset
inhalation aerosol), Corporate Blvd.,
equivalent to (EQ) Bridgewater, NH
0.2 mg base/ 08807.
inhalation.
[[Page 31873]]
NDA 019292................ MD-76R (diatrizoate Liebel-Flarsheim Co.
meglumine and LLC.
diatrizoate sodium)
Injection, 66%/10%.
NDA 020014................ Maxair Autohaler Bausch Health US,
(pirbuterol acetate LLC.
inhalation aerosol),
EQ 0.2 mg base/
inhalation.
NDA 021041................ DepoCyt (cytarabine Pacira
liposome) Injection, Pharmaceuticals,
10 mg/mL. Inc., 5 Sylvan Way,
Suite 300,
Parsippany, NJ
07054.
NDA 021338................ Ionsys (fentanyl The Medicines Co., 8
iontophoresis Sylvan Way,
transdermal system), Parsippany, NJ
40 mcg/activation. 07054.
NDA 021575................ Fosamax (alendronate Merck Sharp & Dohme
sodium) Oral Corp., 1 Merck Dr.,
Solution, EQ 70 mg P.O. Box 100,
base/75 mL. Whitehouse Station,
NJ 08889-0100.
NDA 022222................ Ultresa (pancrelipase Allergan Sales, LLC,
(amylase, lipase, 5 Giralda Farms,
protease)), Delayed- Madison, NJ 07940.
Release Capsules,
8,000 USP Units/
4,000 USP Units/
8,000 USP Units and
27,600 USP Units/
13,800 USP Units/
27,600 USP Units,
and 41,400 USP Units/
20,700 USP Units/
41,400 USP Units,
and 46,000 USP Units/
23,000 USP Units/
46,000 USP Units.
NDA 022396................ Dyloject (diclofenac Javelin
sodium) Injection, Pharmaceuticals,
37.5 mg/mL. Inc., a subsidiary
of Hospira Inc., 275
North Field Dr.,
Dept. 0392, Bldg. H1-
3S, Lake Forest, IL
60045.
NDA 203568................ Kynamro (mipomersen Kastle Therapeutics,
sodium) Injection, 181 West Madison
200 mg/mL. St., Suite 300,
Chicago, IL 60602.
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Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of
August 2, 2019. 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 August 2, 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: June 28, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-14219 Filed 7-2-19; 8:45 am]
BILLING CODE 4164-01-P