Ortho-McNeil Pharmaceutical, Inc. v. Apotex, Inc.

Filing 125

MOTION by Counter Claimants Apotex, Inc., Apotex, Inc., Defendant Apotex, Inc. for judgment and to Terminate the Stay of Final FDA Marketing Approval (Attachments: # 1 Exhibit A)(Rollo, Sherry)

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration Rockville, MD 20857

ANDA 77-858

Mylan Pharmaceuticals Inc.
U.S. Agent for: Alphapharm Pty Ltd.
Attention: Ronald T. Groman, Director
Regulatory Affairs
781 Chestnut Ridge Road
P.O. Box 4310
Morgantown, WV 26504-4310

Dear Sir:
This is in reference to your abbreviated new drug application
(ANDA) dated August 26, 2005, submitted pursuant to section
505(j) of the Federal Food, Drug, and Cosmetic Act (the Act),
for Tramadol Hydrochloride and Acetaminophen Tablets,
37.5 mg/325 mg.
Reference is also made to the tentative approval letter issued
by this office on January 31, 2007, and to your amendments dated
May 23, July 14, and October 31, 2006; and May 2, July 8, and
August 4, 2008.
We have completed the review of this ANDA and have concluded
that adequate information has been presented to demonstrate that
the drug is safe and effective for use as recommended in the
submitted labeling. Accordingly the ANDA is approved, effective
on the date of this letter. The Division of Bioequivalence has
determined your Tramadol Hydrochloride and Acetaminophen
Tablets, 37.5 mg/325 mg, to be bioequivalent and, therefore,
therapeutically equivalent to the reference listed drug,
Ultracet Tablets, 37.5 mg/325 mg, of Ortho-McNeil
Pharmaceutical, Inc. Your dissolution testing should be
incorporated into the stability and quality control program
using the same method proposed in your ANDA.
The reference listed drug (RLD) upon which you have based your
ANDA, Ultracet Tablets, 325 mg/37.5 mg of Ortho-McNeil
Pharmaceutical, Inc. (Ortho-McNeil), is subject to a period of
patent protection.

As noted in the agency's publication titled Approved Drug
Products with Therapeutic Equivalence Evaluations (the "Orange
Book"), U.S. Patent No. RE39221 (the '221 patent), is scheduled
to expire on August 9, 2011.
Following receipt of the tentative approval, you provided a
paragraph IV certification to the '221 patent under section
505(j)(2)(A)(vii)(IV) of the Act stating that this reissued
patent is invalid, unenforceable, or will not be infringed by
your manufacture, use, or sale of Tramadol Hydrochloride and
Acetaminophen Tablets, 37.5 mg/325 mg, under this ANDA. Section
505(j)(5)(B)(iii) of the act provides that approval of an ANDA
shall be made effective immediately, unless an action was
brought against Alphapharm Pty Ltd. (Alphapharm) for
infringement of the listed '221 patent. This action must have
been brought against Alphapharm prior to the expiration of 45
days from the date the notice you provided under section 505
(j)(2)(B)(i) was received by the NDA/patent holder(s). You have
notified the agency that Alphapharm complied with the
requirements of section 505(j)(2)(B) of the Act, and that
litigation was initiated against Alphapharm for infringement of
the '221 patent in the United States District Court for the
Northern District of Illinois, Eastern Division [Ortho-McNeil
Pharmaceutical, Inc. v. Mylan Pharmaceuticals, Inc., et al.,
Civil Action No. 08 C 1343]. You have also notified the agency
that the court entered a judgment reflecting the decision to
dismiss this litigation. This judgment serves to lift the
statutory 30-month stay and renders this ANDA eligible for
approval.
Under section 506A of the Act, certain changes in the conditions
described in this ANDA require an approved supplemental
application before the change may be made.
We note that if FDA requires a Risk Evaluation & Mitigation
Strategy (REMS) for a listed drug, an ANDA citing that listed
drug also will be required to have a REMS, See 505-1(i).
Postmarketing reporting requirements for this ANDA application
are set forth in 21 CFR 314.80-81 and 314.98. The Office of
Generic Drugs should be advised of any change in the marketing
status of this drug.

Promotional materials may be submitted to FDA for comment prior
to publication or dissemination. Please note that these
submissions are voluntary. If you desire comments on proposed
launch promotional materials with respect to compliance with
applicable regulatory requirements, we recommend you submit, in
draft or mock-up form, two copies of both the promotional
materials and package insert directly to:
Food and Drug Administration
Center for Drug Evaluation and Research
Division of Drug Marketing, Advertising, and Communications
5901-B Ammendale Road
Beltsville, MD 20705
We call your attention to 21 CFR 314.81(b)(3) which requires
that all promotional materials be submitted to the Division of
Drug Marketing, Advertising, and Communications with a completed
Form FDA 2253 at the time of their initial use.
Within 14 days of the date of this letter, submit updated
content of labeling [21 CFR 314.50(1)] in structured product
labeling (SPL) format, as described at
http://www.fda.gov/oc/datacouncil/spl.html, that is identical in
content to the approved labeling. Upon receipt and
verification, we will transmit that version to the National
Library of Medicine for public dissemination. For
administrative purposes, please designate this submission as
"Miscellaneous Correspondence ­ SPL for Approved ANDA 77-858".

Sincerely yours,

{See appended electronic signature page}

Gary Buehler
Director
Office of Generic Drugs
Center for Drug Evaluation and Research