DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Silver Spring MD 20993

NDA 207970
TENTATIVE APPROVAL
Actavis LLC
Attention: Joann Stavole, MS, RAC
Director, Regulatory Affairs
400 Interpace Parkway
Parsippany, NJ 07054

Dear Ms. Stavole:
Please refer to your New Drug Application (NDA) dated October 23, 2014, received
October 23, 2014, submitted pursuant to section 505(b)(2) of the Federal Food, Drug, and
Cosmetic Act for Cabazitaxel Injection, Solution, 10 mg/mL.
We acknowledge receipt of your amendments dated December 18, 2014, January 28 and 30,
March 6, 16, and 25, April 23 (2), June 10 (2), 2015 and August 5 and 12, 2015.
This NDA provides for the use of Cabazitaxel Injection, Solution, 10 mg/mL in patients with
hormone-refractory metastatic prostate cancer previously treated with a docetaxel-containing
treatment regimen.
We have completed our review of this application, as amended. It is tentatively approved under
21 CFR 314.105 for use as recommended in the preliminary enclosed labeling (text for the
package insert, text for the patient package insert, carton and immediate container labels). 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]. This determination is subject to change
on the basis of any new information that may come to our attention.
The listed drug upon which your application relies is subject to a period of patent and/or
exclusivity protection and therefore final approval of your application under section 505(c)(3) of
the Act [21 U.S.C. 355(c)(3)] may not be made effective until the period has expired.
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

Reference ID: 3808382

 NDA 207970
Page 2

brought for infringement of one or more of the patents that were the subject of the paragraph IV
certifications. This action must be taken prior to the expiration of forty-five days from the date
the notice provided under section 505(b)(3) is received by the patent owner/approved application
holder. You notified us that you complied with the requirements of section 505(b)(3) of the Act.
In addition, you have notified the Agency that the patent owner and/or approved application
holder has initiated a patent infringement suit against you with respect to patents 5847170 and
7241907, Case 3: 3:15-cv-00776-MAS-LHG, and patent 8927592, Case 3:15-cv-03107-MAS­
LHG, in the U.S. District Court for the District of New Jersey. Therefore, final approval cannot
be granted until:
1.  a. expiration of the 30-month period provided for in Section 505(c)(3)(C) beginning on
the date of receipt of the 45-day notice required under Section 505(b)(3), unless the
court has extended or reduced the period because of the failure of either party to
reasonably cooperate in expediting the action, or
b. the date the court decides that the patents are invalid or not infringed as described in
section 505(c)(3)(C)(i), (ii), (iii,) or (iv) of the Act, or,
c. the listed patents have expired, and
2.  we are assured there is no new information that would affect whether final approval
should be granted.
To obtain final approval of this application, submit an amendment two or six months prior to the:
1) expiration of the patent(s), or 2) date you believe that your NDA will be eligible for final
approval, as appropriate. In your cover letter, clearly identify your amendment as “REQUEST
FOR FINAL APPROVAL”. This amendment should provide the legal/regulatory basis for
your request for final approval and should include a copy of any relevant court order or judgment
settlement, or licensing agreement, as appropriate. 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). If there are no changes, clearly state so in your cover letter.
Any changes require our review before final approval and the goal date for our review will be set
accordingly. Lastly, your amendment should provide updated labeling that reflects the most
recent revisions to the reference listed drug labeling.
Until we issue a final approval letter, this NDA is not deemed approved.
Please note that this drug product may not be marketed in the United States without final agency
approval under Section 505 of the Act. The introduction or delivery for introduction into
interstate commerce of this drug product before the final approval date is prohibited under
Section 501 of the Act and 21 U.S.C. 331(d).
PROPRIETARY NAME
If you intend to have a proprietary name for this product, the name and its use in the labels must
conform to the specifications under 21 CFR 201.10 and 201.15. We recommend that you submit

Reference ID: 3808382

 NDA 207970
Page 3

a request for a proposed proprietary name review. See the guidance for industry titled, “Contents
of a Complete Submission for the Evaluation of Proprietary Names”, at
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/u
cm075068.pdf and “PDUFA Reauthorization Performance Goals and Procedures Fiscal Years
2008 through 2012”.
METHODS VALIDATION
We have not completed validation of the regulatory methods. However, we expect your
continued cooperation to resolve any problems that may be identified.
If you have any questions, contact Elleni Alebachew, Regulatory Project Manager, at
(301) 796-5225.
Sincerely,
{See appended electronic signature page}
Amna Ibrahim, M.D.
Deputy Director
Division of Oncology Products 1
Office of Hematology and Oncology Products
Center for Drug Evaluation and Research

ENCLOSURE(S):
Content of Labeling
Carton and Container Labeling

Reference ID: 3808382

 --------------------------------------------------------------------------------------------------------This is a representation of an electronic record that was signed
electronically and this page is the manifestation of the electronic
signature.
--------------------------------------------------------------------------------------------------------/s/
---------------------------------------------------AMNA IBRAHIM
08/19/2015

Reference ID: 3808382