Amarin Corp Plc (AMRN)

[iryokabu]

HDG,

"Almost" (as AB is the most common TE code)... but is not entirely. A generic could be a products that FDA considers not to be therapeutically equivalent to other pharmaceutically equivalent products. These generics get a "Bx" code ... "Ax" (AB) code is not the one and only possible TE code.

From FDA website:

Generic drug applications are termed "abbreviated" because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. Instead, generic applicants must scientifically demonstrate that their product is performs in the same manner as the innovator drug. One way applicants demonstrate that a generic product performs in the same way as the innovator drug is to measure the time it takes the generic drug to reach the bloodstream in healthy volunteers. This demonstration of “bioequivalence” gives the rate of absorption, or bioavailability, of the generic drug, which can then be compared to that of the innovator drug. To be approved by FDA, the generic version must deliver the same amount of active ingredients into a patient's bloodstream in the same amount of time as the innovator drug.

"B" CODES

Drug products that FDA, at this time, considers not to be therapeutically equivalent to other pharmaceutically equivalent products.

"B" products, for which actual or potential bioequivalence problems have not been resolved by adequate evidence of bioequivalence, often have a problem with specific dosage forms rather than with the active ingredients. Drug products designated with a "B" code fall under one of three main policies:

(1) the drug products contain active ingredients or are manufactured in dosage forms that have been identified by the Agency as having documented bioequivalence problems or a significant potential for such problems and for which no adequate studies demonstrating bioequivalence have been submitted to FDA; or

(2) the quality standards are inadequate or FDA has an insufficient basis to determine therapeutic equivalence; or

(3) the drug products are under regulatory review.


Based on this, anybody should think Hikma's generics is anything but B at that moment. It may become B in the future.

But looks like Hikma would be on the safest side ... both PR are available on independent news site (or by a direct Google search for Hikma media) only but are not by Hikma / Press release section.

It was too late for them to remove PR. We have an evidence of their PR as PDF or screenshot.