Mylan receives final FDA approvals for generic Lamictal tablets (News-Medical-Net)
Mylan Inc has announced that its subsidiaries Mylan Pharmaceuticals Inc. and Genpharm ULC received final approvals from the U.S. Food and Drug Administration (FDA) for their Abbreviated New Drug Applications (ANDAs) for Lamotrigine Tablets.

FDA Grants IND Status To Clinuvel's Photoprotective Afamelanotide (Medical News Today)
Melbourne-based Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced that it has obtained Investigational New Drug (IND) status for its photoprotective drug afamelanotide from the US Food and Drug Administration (FDA). Clinuvel can now commence clinical trials in the US, the world's largest pharmaceutical market.