Sun Pharmaceutical Industries, Ltd.; Withdrawal of Approval of Three Abbreviated New Drug Applications


Federal Register, Volume 83 Issue 87 (Friday, May 4, 2018)

Federal Register Volume 83, Number 87 (Friday, May 4, 2018)


Page 19787

From the Federal Register Online via the Government Publishing Office

FR Doc No: 2018-09533



Food and Drug Administration

Docket No. FDA-2018-N-1534

Sun Pharmaceutical Industries, Ltd.; Withdrawal of Approval of Three Abbreviated New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA or Agency) is withdrawing approval of three abbreviated new drug applications (ANDAs) held by Sun Pharmaceutical Industries, Ltd., c/o Sun Pharmaceutical Industries, Inc. (Sun Pharmaceutical). These drug products are no longer marketed, and Sun Pharmaceutical has requested that the approval of the applications be withdrawn.

DATES: Approval is withdrawn as of June 4, 2018.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: Sun Pharmaceutical has informed FDA that these drug products are no longer marketed and requested that FDA withdraw approval of the applications. Sun Pharmaceutical has also waived its opportunity for a hearing and requested withdrawal of approval under a Consent Decree of Permanent Injunction (Decree) entered in United States v. Ranbaxy Laboratories, Ltd. et al., JFM 12-

250 (D. Md.) on January 26, 2012. The Decree specifies that Sun Pharmaceutical must never submit another application to FDA for these withdrawn drugs and must never transfer these ANDAs to a third party.


Application No. Drug Applicant


ANDA 065174..................... Clarithromycin Sun Pharmaceutical

Tablets USP, 250 Industries, Ltd.,

milligrams (mg) c/o Sun

and 500 mg. Pharmaceutical

Industries, Inc.,

2 Independence

Way, Princeton,

NJ 08540.

ANDA 065382..................... Clarithromycin for Do.

Oral Suspension

USP, 125 mg/5

milliliters (mL)

and 250 mg/5 mL.

ANDA 075747..................... Ciprofloxacin Do.

Tablets USP,

Equivalent to

(EQ) 250 mg base,

EQ 500 mg base,

and EQ 750 mg



Therefore, approval of the applications listed in the above table, and all amendments and supplements thereto, is hereby withdrawn as of June 4, 2018.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)).

Dated: May 1, 2018.

Leslie Kux,

Associate Commissioner for Policy.

FR Doc. 2018-09533 Filed 5-3-18; 8:45 am