Novartis Pharmaceuticals Corporation, et al.; Withdrawal of Approval of Five New Drug Applications
Federal Register, Volume 83 Issue 120 (Thursday, June 21, 2018)
Federal Register Volume 83, Number 120 (Thursday, June 21, 2018)
Notices
Pages 28856-28857
From the Federal Register Online via the Government Publishing Office www.gpo.gov
FR Doc No: 2018-13293
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2018-N-2194
Novartis Pharmaceuticals Corporation, et al.; Withdrawal of Approval of Five New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is withdrawing approval of five new drug applications (NDAs) 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
DATES: Approval is withdrawn as of July 23, 2018.
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 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.
------------------------------------------------------------------------
Application No. Drug Applicant
------------------------------------------------------------------------
NDA 020831............. Foradil Aerolizer Novartis
(formoterol fumarate) Pharmaceuticals
Powder, 0.012 Corp., One Health
milligram (mg)/ Pl., East Hanover, NJ
inhalation. 07936.
NDA 022504............. Axiron (testosterone) Eli Lilly and Co.,
Transdermal Metered Lilly Corporate
Solution, 30 mg/1.5 Center, Indianapolis,
milliliter (mL) IN 46285.
actuation.
NDA 050585............. Rocephin (ceftriaxone Hoffmann-La Roche,
sodium) for Injection, Inc., c/o Genentech,
equivalent to (EQ) 10 Inc., 1 DNA Way,
gram (g) base/vial, EQ South San Francisco,
250 mg base/vial (IV/ CA 94080.
IM), EQ 500 mg base/
vial (IV/IM), EQ 1 g
base/vial (IV/IM), EQ
2 g base/vial (IV/IM),
EQ 500 mg base/vial, N/
A; N/A, 1% (Rocephin
kit), EQ 1 g base/
vial, N/A; N/A, 1%
(Rocephin kit).
NDA 050624............. Rocephin (ceftriaxone Do.
sodium) with Dextrose
in Plastic Container
Injection, EQ 10 mg
base/mL, EQ 20 mg base/
mL, and EQ 40 mg base/
mL.
NDA 202763............. Testosterone Gel, 25 mg/ ANI Pharmaceuticals,
2.5 g packet, 50 mg/5 Inc., 210 Main St.
g packet. West, Baudette, MN
56623.
------------------------------------------------------------------------
Page 28857
Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of July 23, 2018. 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 July 23, 2018 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 14, 2018.
Leslie Kux,
Associate Commissioner for Policy.
FR Doc. 2018-13293 Filed 6-20-18; 8:45 am
BILLING CODE 4164-01-P
