Sun Pharmaceutical Industries, Ltd., and Sun Pharma Global FZE; Withdrawal of Approval of Four Abbreviated New Drug Applications

 
CONTENT

Federal Register, Volume 83 Issue 50 (Wednesday, March 14, 2018)

Federal Register Volume 83, Number 50 (Wednesday, March 14, 2018)

Notices

Page 11208

From the Federal Register Online via the Government Publishing Office www.gpo.gov

FR Doc No: 2018-05120

Page 11208

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Docket No. FDA-2018-N-0793

Sun Pharmaceutical Industries, Ltd., and Sun Pharma Global FZE; Withdrawal of Approval of Four 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 abbreviated new drug applications (ANDAs) from two 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

DATES: Approval is withdrawn as of April 13, 2018.

FOR FURTHER INFORMATION CONTACT: Trang Tran, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1671, Silver Spring, MD 20993-0002, 240-402-7945, email protected.

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.

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Application No. Drug Applicant

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ANDA 075556.................. Enalapril Maleate Sun Pharmaceutical

Tablets USP, 2.5 Industries, Ltd.,

milligrams (mg), 5 c/o Sun

mg, 10 mg, and 20 Pharmaceutical

mg. Industries, Inc.,

2 Independence

Way, Princeton, NJ

08540.

ANDA 076045.................. Lorazepam Tablets Do.

USP, 0.5 mg, 1 mg,

and 2 mg.

ANDA 078055.................. Zolpidem Tartrate Do.

Tablets USP, 5 mg

and 10 mg.

ANDA 090018.................. Zoledronic Acid for Sun Pharma Global

Injection, FZE, c/o Sun

Equivalent to 4 mg Pharmaceutical

base/vial. Industries, Inc.,

2 Independence

Way, Princeton, NJ

08540.

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Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of April 13, 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 April 13, 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: March 8, 2018.

Leslie Kux,

Associate Commissioner for Policy.

FR Doc. 2018-05120 Filed 3-13-18; 8:45 am

BILLING CODE 4164-01-P