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Documents on Antitrust & Trade Regulation, Pharmaceuticals, Health Care
 

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HTMLFDA Rejects Otsuka’s Assertions of Orphan Exclusivity for Abilify, Allowing Generics to Proceed
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
May 15, 2015, previously published on April 2015
The impact of the FDA’s decision is that several companies will be allowed to enter the market with generic aripiprazole, although the generics must carve out the use of the drug for treating pediatric Tourette’s Disorder from their labeling and marketing while the exclusivity period...

 

HTMLFTC Says New York’s Medicaid Redesign Program May Promote Anticompetitive Behavior
Dionne C. Lomax, Stephen M. Weiner, Nili S. Yolin; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
Legal Alert/Article
May 14, 2015, previously published on May 4, 2015
In an April 22, 2015 letter to the New York State Department of Health (DOH), the Federal Trade Commission (FTC) cautioned that part of the State’s Medicaid reform program may sanction anticompetitive behavior. The FTC’s concern stems from the Certificate of Public Advantage (COPA)...

 

HTMLFTC Flushes McWane in a Big Eleventh Circuit Exclusive Dealing Win
Helen J. Kim, Timothy J. Slattery, Bruce D. Sokler; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
Legal Alert/Article
May 6, 2015, previously published on April 22, 2015
The situations where exclusive dealing policies, explicit or tied to an aggressive discounting program, cross the line under the rule-of-reason remain far from clear. Because it involved appellate review of a Federal Trade Commission (“FTC” or the “Commission”) ruling...

 

HTMLFTC Settles Radioactive Allegations Against Cardinal Health with a Near Record-Breaking Disgorgement Agreement
Helen J. Kim, Dionne C. Lomax, Bruce D. Sokler; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
Legal Alert/Article
May 6, 2015, previously published on April 21, 2015
In a 3-2 decision, as part of its aggressive antitrust enforcement in health care industries, the Federal Trade Commission (FTC or the Commission) announced that Cardinal Health, Inc. (Cardinal) agreed to pay $26.8 million to resolve the FTC’s allegations that Cardinal illegally monopolized...

 

HTMLOPDP Warning Letter States That Discovery Laboratories’ Website for Surfaxin Makes Unsubstantiated Superiority Claims, Lacks Adequate Directions for Unapproved Use
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
April 22, 2015, previously published on March 2015
Discovery Laboratories was warned by the regulator after a review of its website revealed that the company made unsupported superiority claims about Surfaxin as well as claims indicating that the RDS-prevention drug is intended for a use for which it lacks approval and for which its labeling fails...

 

HTMLOPDP Sends Warning Letter to UCLA for Promoting Investigational New Drug on Taumark Website
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
April 22, 2015, previously published on March 2015
The regulator warned UCLA, a partner in TauMark and the sponsor of the investigational new drug FDDNP, that it is violating the FD&C Act by promoting the brain diagnostic drug without market authorization and by failing to include adequate directions for use.

 

HTMLFDA Warns Nanobiotech Pharma for Using Metatags and Social Media to Make Improper Claims about Its Products
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
April 22, 2015, previously published on March 2015
The regulator sent a warning letter to the life science company for using metatags to supplement the improper promotion of its products as drugs, as well as making unapproved claims on Facebook, LinkedIn and its website.

 

HTMLFDA Approves Novartis’ Zarxio As The First Biosimilar In The U.S., Clearing The Drug For The Same Indications As Neupogen And Giving It A Placeholder Nonproprietary Name
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
April 22, 2015, previously published on March 2015
The regulator granted a landmark approval to the copycat version of the already approved drug in the U.S., opening up the market to less expensive copies of biological products, while uncertainty related to a naming policy remains.

 

HTMLFDA Issues New Documents Governing Drug Compounding
Patrick C. Gallagher, Rachael G. Pontikes, Alison T. Rosenblum; Duane Morris LLP;
Legal Alert/Article
April 14, 2015, previously published on April 6, 2015
The first few months of 2015 have proven very active for the U.S. Food and Drug Administration (FDA) and its regulation of pharmaceutical compounding. On February 13, 2015, FDA announced the release of five new documents related to drug compounding and repackaging. The documents provide further...

 

HTMLPay-For-Delay In 2014: Courts Fill In The Actavis Gaps
Jonathan Mark Watkins; Zelle Hofmann Voelbel & Mason LLP;
Legal Alert/Article
April 6, 2015, previously published by Competition Law360 on December 19, 2014
A little more than one year ago, the U.S. Supreme Court decided Federal Trade Commission v. Actavis Inc. and affirmed that antitrust principles apply to reverse payment settlement agreements — those in which a brand-name drug manufacturer pays a potential generic competitor to settle a patent...

 


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