Biotech Values

[DewDiligence]

FDA responds to Amphastar’s lawsuit with a bang:

This is the very first paragraph of the FDA’s response (emphasis present in actual document):

Though Amphastar’s Amended Complaint alleges no end of intrigue in FDA’s refusal to approve the company’s application to make a generic enoxaparin product, a single fact is fatal to all of Amphastar’s claims: Amphastar has not satisfied the statutory requirements for approval of a generic drug.

Here is the complete 48-page document filed yesterday with the District Court:

Click here

(Thanks to ‘mouton29’ for making this document available.)