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

NDA 207963
TENTATIVE APPROVAL
Exela Pharma Sciences, LLC.
Attention: Jonathan E. Sterling
Vice President Quality and Regulatory Affairs
P.O. Box 818
1245 Blowing Rock Blvd.
Lenoir, NC 28645
Dear Mr. Sterling:
Please refer to your New Drug Application (NDA) dated August 7, 2014, received August 15,
2014, and your amendments, submitted pursuant to section 505(b)(2) of the Federal Food, Drug,
and Cosmetic Act for Palonosetron Hydrochloride (HCl) Injection, 0.125 mg/mL.
We acknowledge receipt of your amendment dated September 22, 2015, which constituted a
complete response to our June 15, 2015, action letter.
This NDA provides for the use of Palonosetron HCl Injection in adults for the prevention of
chemotherapy-induced nausea and vomiting.
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 agreed-upon enclosed labeling (text for the
package insert, text for the patient package insert) and submitted labeling (carton and immediate
container labels submitted and received March 14, 2016 and March 17, 2016). 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 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

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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 patent 8,518,981 and
8,598,218 in the United States District Court, District of Delaware (Case 1:14-cv-01444-GMS).
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 exclusivity protection 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.
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
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

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cm075068.pdf and “PDUFA Reauthorization Performance Goals and Procedures Fiscal Years
2008 through 2012”.
If you have any questions, call Mary Chung, Regulatory Project Manager, at (301) 796-0260.

Sincerely,
{See appended electronic signature page}

Joyce Korvick, M.D., M.P.H.
Deputy Director for Safety
Division of Gastroenterology and Inborn Errors
Products
Office of Drug Evaluation III
Center for Drug Evaluation and Research

ENCLOSURE(S):
Content of Labeling

Reference ID: 3906115

 --------------------------------------------------------------------------------------------------------This is a representation of an electronic record that was signed
electronically and this page is the manifestation of the electronic
signature.
--------------------------------------------------------------------------------------------------------/s/
---------------------------------------------------JOYCE A KORVICK
03/22/2016

Reference ID: 3906115