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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...

 

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.

 

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...

 

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 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 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...

 

HTMLCanada’s Anti-Spam Law
Bradley J. Freedman; Borden Ladner Gervais LLP;
Legal Alert/Article
April 9, 2015, previously published on March 24, 2015
Canada’s anti-spam law (commonly known as “CASL”) creates a comprehensive regime of offences, enforcement mechanisms and potentially severe penalties (including personal liability for corporate directors and officers) designed to prohibit unsolicited or misleading commercial...

 

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...

 

HTMLFDA Issues Guidance on Registration, Fees and Reporting Requirements for Drug Compounding Outsourcing Facilities
Duane Morris LLP;
Legal Alert/Article
February 26, 2015, previously published on December 9, 2014
On November 21, 2014, the U.S. Food and Drug Administration (FDA) announced the release of three new guidance documents related to drug compounding outsourcing facilities. These documents include:

 

HTMLOffice of Inspector General’s 2015 Work Plan Shows Agency Will Examine Medical Device Security, FDA’s Regulation
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
February 25, 2015, previously published on November 2014
The Department of Health and Human Services’ watchdog agency released a 2015 work plan that calls for federal auditors to assess medical device cybersecurity amid intensifying scrutiny in the area, as well as areas that may be in need of some revamping by the FDA.

 


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