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Re: biotech_researcher post# 61136

Thursday, 03/26/2015 9:28:18 PM

Thursday, March 26, 2015 9:28:18 PM

Post# of 80490

Ariad's Japanese partner now has trouble with the FDA... Imagine that..
http://www.wsj.com/articles/BL-270B-1711


Hi BR,

You'd better read this text at the end of the article:

“…There was nothing innocent or unintentional in FDA’s action,” the lawsuit states. “FDA acted deliberately, intentionally and without justification…” The revised approval “was an attempt to clear a blocked path for FDA’s approval” of generic versions of the antipsychotic.

Basically, Otsuka argues the FDA is not allowed to approve a use for a medicine for which a drug maker did not seek approval. Another aspect of the legal tussle, however, hinges on how to interpret complicated FDA regulations that govern marketing exclusivity for drugs that are approved for children and have orphan designation.

Whether Otsuka will prevail remains to be seen, of course, but for now, the drug maker has succeeded in delaying generic versions of Abilify, if only until the litigation is resolved. [UPDATE: We should note that the lead lawyer for Otsuka is Ralph Tyler, who works at the Venable law firm and was previously chief counsel at the FDA].
..."


There is a high chance of Otsuka winning this case, don't you think?

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