[Federal Register Volume 81, Number 250 (Thursday, December 29, 2016)]
[Notices]
[Pages 96004-96005]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-31625]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0002]
Abbott Laboratories, et al.; Withdrawal of Approval of Four New
Drug Applications and Two Abbreviated New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of four new drug applications (NDAs) and two 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be withdrawn.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: Effective Date: January 30, 2017.
FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6248, Silver Spring, MD 20993-0002, 301-
796-3601.
SUPPLEMENTARY INFORMATION: The holders of the applications 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 pursuant to 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 96005]]
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Application No. Drug Applicant
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NDA 019080.................. ProSom (estazolam) Abbott Laboratories,
Tablets, 1 200 Abbott Park
milligram (mg) and Rd., Abbott Park,
2 mg. IL 60064.
NDA 020195.................. Fentanyl Oralet Cephalon, Inc., 41
(fentanyl citrate) Moores Rd., Frazer,
Troche/Lozenge, PA 19355.
Equivalent to (EQ)
0.1 mg base, EQ 0.2
mg base, EQ 0.3 mg
base, and EQ 0.4 mg
base.
NDA 021726.................. Niravam (alprazolam) UCB, Inc., 1950 Lake
Orally Park Dr., Building
Disintegrating 2100, Smyrna, GA
Tablets, 0.25 mg, 30080.
0.5 mg, 1 mg, and 2
mg.
ANDA 084287................. Methyltestosterone Impax Laboratories,
Tablets USP, 10 mg. Inc., 31047 Genstar
Rd., Hayward, CA
94544.
ANDA 084310................. Methyltestosterone Do.
Tablets USP, 25 mg.
NDA 205208.................. Desvenlafaxine Teva Pharmaceuticals
Fumarate Extended- USA, Inc., 425
Release Tablets, EQ Privet Rd.,
50 mg base and EQ Horsham, PA 19044.
100 mg base.
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Therefore, under section 505(e) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 355(e)) and under authority
delegated to the Director, Center for Drug Evaluation and Research, by
the Commissioner, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn, effective
January 30, 2017. Introduction or delivery for introduction into
interstate commerce of products without approved new drug applications
violates section 301(a) and (d) of the FD&C Act (21 U.S.C. 331(a) and
(d)). Drug products that are listed in the table 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: December 23, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-31625 Filed 12-28-16; 8:45 am]
BILLING CODE 4164-01-P