Document Headings

                    Document headings vary by document type but may contain                    the following:                  
                -                       the agency or agencies that issued and signed a document                    
                -                       the number of the CFR title and the number of each part                      the document amends, proposes to amend, or is directly                      related to                    
                -                       the agency docket number / agency internal file number                    
                -                       the RIN which identifies each regulatory action listed in                      the Unified Agenda of Federal Regulatory and Deregulatory                      Actions                    

                    See the                                          Document Drafting Handbook                                        for more details.                  

###### Department of Health and Human Services

###### Food and Drug Administration

          - [Docket No. FDA-2017-N-0002]

# AGENCY:

Food and Drug Administration, HHS.

# ACTION:

Notice.

# SUMMARY:

The Food and Drug Administration (FDA or the Agency) is withdrawing approval of an abbreviated new drug application (ANDA) for PROPRANOLOL HYDROCHLORIDE Extended-Release Capsules, held by Upsher-Smith Laboratories, Inc. (Upsher-Smith), 6701 Evenstad Dr., Maple Grove, MN 55369. Upsher-Smith has voluntarily requested that approval of this application be withdrawn and has waived its opportunity for a hearing.

# DATES:

August 30, 2017.

# FOR FURTHER INFORMATION CONTACT:

Stefanie Kraus, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6215, Silver Spring, MD 20993-0002, 301-796-9585.

# SUPPLEMENTARY INFORMATION:

On March 6, 2009, FDA approved abbreviated new drug application (ANDA) 078311 for PROPRANOLOL HYDROCHLORIDE Extended-Release Capsules, USP, 60 milligrams (mg), 80 mg, 120 mg, and 160 mg. In a letter dated August 9, 2011, FDA informed Upsher-Smith that it had concerns about the validity of bioequivalence data submitted with ANDA 078311 from studies conducted by a certain contract research organization, establishing bioequivalence of Upsher-Smith's product to the reference listed drug (RLD), INDERAL LA (propranolol hydrochloride) Extended Release Capsules, 60 mg, 80 mg, 120 mg, and 160 mg. In that letter, FDA directed Upsher-Smith to supplement its ANDA with either: (1) New bioequivalence studies or (2) re-assays of the samples from the original bioequivalence studies. Upsher-Smith submitted new fasted and fed bioequivalence studies to supplement ANDA 078311 in paper format on August 29, 2013, and in electronic format on May 9, 2014.

On April 14, 2016, FDA informed Upsher-Smith that the applicant's fed bioequivalence study failed to meet FDA's bioequivalence criteria and, therefore, requested that Upsher-Smith voluntarily seek withdrawal of ANDA 078311 under § 314.150(d) (21 CFR 314.150(d)).

In a letter dated May 13, 2016, Upsher-Smith requested that FDA withdraw approval of ANDA 078311 for PROPRANOLOL HYDROCHLORIDE Extended-Release Capsules under § 314.150(d) because the new bioequivalence data did not demonstrate therapeutic equivalence of its product to the RLD, INDERAL LA. In that letter, Upsher-Smith also waived any opportunity for a hearing otherwise provided under § 314.150(a).

                    Therefore, under section 505(e) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(e)) and § 314.150(d), and under authority delegated by the Commissioner of Food and Drugs to the Director, Center for Drug Evaluation and Research, approval of ANDA 078311, and all amendments and supplements thereto, is withdrawn (see                     **DATES**                    ). Distribution of this product in interstate commerce without an approved application is illegal and subject to regulatory action (see sections 505(a) and 301(d) of the FD&C Act (21 U.S.C. 355(a) and 331(d)).                

Dated: August 24, 2017.

Anna K. Abram,

Deputy Commissioner for Policy, Planning, Legislation, and Analysis.

[FR Doc. 2017-18375 Filed 8-29-17; 8:45 am]

 BILLING CODE 4164-01-P