81 FR 96004 - Abbott Laboratories, et al.; Withdrawal of Approval of Four New Drug Applications and Two Abbreviated New Drug Applications

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 250 (December 29, 2016)

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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

[Federal Register Volume 81, Number 250 (Thursday, December 29, 2016)]
[Notices]
[Pages 96004-96005]
From the Federal Register Online  [www.thefederalregister.org]
[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be withdrawn.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]]



------------------------------------------------------------------------
       Application No.                Drug                Applicant
------------------------------------------------------------------------
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.
------------------------------------------------------------------------

    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