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

NDA 208286
TENTATIVE APPROVAL
Dr. Reddy’s Laboratories Limited
Attention: Hari Nagaradona, PhD
Vice President/Head of Regulatory Affairs
107 College Road East
Princeton, New Jersey 08540

Dear Dr. Nagaradona:
Please refer to your New Drug Application (NDA) dated March 27, 2015, received March 30,
2015, and your amendments, submitted pursuant to section 505(b)(2) of the Federal Food, Drug,
and Cosmetic Act for Zenavod (doxycycline) capsule, 40 mg.
This NDA provides for the use of Zenavod (doxycycline) capsules, 40 mg for the treatment of
only inflammatory lesions (papules and pustules) of rosacea in adult patients.
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 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 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
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.

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 NDA 208286
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In addition, you have notified the Agency that the patent owner and/or approved application
holder has initiated a patent infringement suit against you in the United States District Court for
the District of Delaware (Galderma Laboratories, LP et al v. Dr. Reddy’s Laboratories, Ltd, et al/
Civil Action No 15-670) with respect to the following patents:
U.S. Patent No. 7,211,267 - Expiry Date: Apr. 5, 2022
U.S. Patent No. 7,232,572 - Expiry Date: Apr. 5, 2022
U.S. Patent No. 7,749,532 - Expiry Date: Dec. 19, 2027
U.S. Patent No. 8,206,740 - Expiry Date: Dec. 24, 2025
U.S. Patent No. 8,394,405 - Expiry Date: Apr. 7, 2024
U.S. Patent No. 8,394,406 - Expiry Date: Apr. 7, 2024
U.S. Patent No. 8,470,364 - Expiry Date: Apr. 7, 2024
U.S. Patent No. 8,603,506 - Expiry Date: Apr. 5, 2022
U.S. Patent No. 8,709,478 - Expiry Date: Apr. 7, 2024
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 patents 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).
REQUIRED PEDIATRIC ASSESSMENTS

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 NDA 208286
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Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new
active ingredients, new indications, new dosage forms, new dosing regimens, or new routes of
administration are required to contain an assessment of the safety and effectiveness of the
product for the claimed indication in pediatric patients unless this requirement is waived,
deferred, or inapplicable.
We note that if this application is ultimately approved, you will need to meet these requirements.
If you have any questions, call Omolara Laiyemo, Regulatory Project Manager, at (240) 402­
3842.

Sincerely,
{See appended electronic signature page}

Jill A. Lindstrom, MD, FAAD
Deputy Director
Division of Dermatology and Dental Products
Office of Drug Evaluation III
Center for Drug Evaluation and Research

ENCLOSURES:
Content of Labeling
Carton and Container Labeling

Reference ID: 3877445

 --------------------------------------------------------------------------------------------------------This is a representation of an electronic record that was signed
electronically and this page is the manifestation of the electronic
signature.
--------------------------------------------------------------------------------------------------------/s/
---------------------------------------------------JILL A LINDSTROM
01/27/2016

Reference ID: 3877445