Bioequivalence and Bioavailability Forum

Hi Helmut,

interesting story
I read:

MSN’s findings also diverge substantially from the Cmax and AUC∞ found for the same lot of reference listed drug that was tested by another generic manufacturer (Apotex) with an approved ANDA for tasimelteon (No. 211607).

So they acknowleged another generic, but don't have any problems with that. Why? Take a look at this FDA letter to Apotex:

Therefore, final approval cannot be granted until:

1. 1. the expiration of the 7.5-year period provided for in sections 505(j)(5)(B)(iii)
      and 505(j)(5)(F)(ii) of the FD&C Act,
      
   2. the date the court decides2 that the '995, '234, '913, '910, '241, and '604
      patents are invalid or not infringed (see sections 505(j)(5)(B)(iii)(I), (II), and
      (III) of the FD&C Act), or
      
   3. The '529, '995, '234, '913, '910, '241, and '604 patents have expired, and
2. The Agency is assured there is no new information that would affect whether final approval should be granted.

touché!

regarding current study from your link:

Exhibit 2, 2015 Guidance, supra. Accordingly, under FDA’s guidance, MSN’sstudy should have included females and males, as well as individuals from a range of races and ethnicities, reflective of the overall U.S. population. See Roth Decl. ¶¶ 41-42. Because MSN’s study did not, FDA unlawfully concluded that “the demographics profile of subjects completing the bioequivalence study [is] in agreement with the current drug product recommendation.” Exhibit 1, MSN Bioequivalence Review, supra, at 23; see also Roth Decl. ¶¶ 47-59.

Didn't we see something similar already in 2000s?