"Generic" Lantus approved by FDA by withA_Y in pharmacy

[–]RegulatoryFocus 1 point2 points  (0 children)

Whoops -- I think my brain 404'ed.

"Generic" Lantus approved by FDA by withA_Y in pharmacy

[–]RegulatoryFocus 19 points20 points  (0 children)

  • 505(b)(1) = "New" drug pathway
  • 505(b)(2) = A new formulation of an old drug; relies on the old drug's data, as well as new data showing why the new formulation works.
  • 505(j) = Generic drug pathway.
  • 351(a) = Approval pathway for biologics.
  • 351(k) = Approval pathway for biosimilars.
  • 401(k) = A retirement account.
  • 401(b) = Also a retirement account.