FDA Approves ISOTRETINOIN — Upsher-Smith Laboratories, LLC

Upsher-Smith Laboratories announced today that the FDA has granted final approval to its Abbreviated New Drug Application (ANDA) for generic isotretinoin, marking the entry of a novel competitor in a market that has been effectively consolidated since the withdrawal of other branded versions. With the availability of a generic alternative, the company stands to secure a significant share of oral isotretinoin sales, adding a high-revenue, profitable product to its portfolio without the need for further clinical trials.