RAPS

FDA announces website for complex generics

The US Food and Drug Administration (FDA) just launched a new webpage to share recent actions and activities related to complex generic drugs to spur their development. “Since these products are ...
RAPS

FDA finalizes guidances on complex generics meetings, drug development tools

The US Food and Drug Administration (FDA) has finalized guidance for industry on the pathway for discussions about complex products. The final guidance leaves largely untouched a 2017 draft guidance ...
Morningstar

Apotex Receives First U.S. FDA Tentative Approval for a Generic Version of Ozempic ...

WESTON, Fla., April 10, 2026 /PRNewswire/ - Apotex Corp. today announced it has received the first U.S. Food and Drug Administration (FDA) Tentative Approval for its Abbreviated New Drug Application ...
Morningstar

DifGen Pharmaceuticals Receives FDA Approval for Generic Mesalamine Extended-Release ...

MIRAMAR, Fla., March 11, 2026 /PRNewswire/ -- DifGen Pharmaceuticals LLC, a U.S.-based specialty generic pharmaceutical company today announced that the U.S. Food and Drug Administration (FDA) has ...