Hospira, Inc.: Daptomycin

Cosmetic Act (FDCA) for Bortezomib for Injection, 2.5 mg/vial.

Establish a validated test method for elemental impurities as part of the drug product specification consistent with ICH Q3D and USP <232/233>.

Update the drug product specifications accordingly with controls for elemental impurities, if necessary.

Submit draft carton and container labeling that are identical to the carton and immediate container labels submitted on December 22, 2017.

Submit draft carton and container labeling that are identical to the carton and immediate container labels submitted on October 18, 2017.

Cosmetic Act for Bortezomib for Injection, 2.5 mg/vial.

This NDA provides for the use of Bortezomib for Injection, 2.5 mg/vial for the treatment of patients with multiple myeloma.

21 CFR 314.105 for use as recommended in the agreed-upon enclosed labeling (text for the package insert, submitted carton and immediate container labels submitted April 14, 2017).

This determination is based upon information available to the Agency at this time, [i.e., information in your application and the status of current good manufacturing practices (CGMPs) of the facilities used in the manufacture and testing of the drug product].

Your application contains certifications to each of the patents under section 505(b)(2)(A)(iv) of the Act stating that the patents are invalid, unenforceable, or will not be infringed by your manufacture, use, or sale of, this drug product under this application ("Paragraph IV certifications").

Section 505(c)(3)(C) of the Act provides that approval of a new drug application submitted pursuant to section 505(b)(2) of the Act shall be made effective immediately, unless an action is brought for infringement of one or more of the patents that were the subject of the paragraph IV certifications.

Therefore, final approval cannot be granted until:

To obtain final approval of this application, submit an amendment two or six months prior to the:

In addition to a safety update, the amendment should also identify changes, if any, in the conditions under which your product was tentatively approved, i.e., updated labeling; chemistry, manufacturing, and controls data; and risk evaluation and mitigation strategy (REMS).

We note that if this application is ultimately approved, you will need to meet these requirements.