Momenta Pharmaceuticals, Inc. (MNTA)

[Goo111]

<<I do not understand what you mean. If generic Copaxone is approved under 505(j), why would it need to be “transitioned”? <<

Don't ask me... ask the FDA...

"As of March 23, 2020, an application for a biological product approved under section 505 of the FD&C Act will be deemed a biologics license application (“BLA”) licensed under section 351 of the PHS Act."