Complex generic may have some wiggle room, but the only choice for many sponsors may be to redo the affected studies or withdraw the products that have lost bioequivalence status after FDA questioned the integrity of the data from two contract researchers.

Sponsors must decide whether to repeat bioequivalence and other studies after two CROs were found to have potentially falsified data, causing the US FDA to reject all data produced by the firms.

Cipla, which has long-standing experience in antibiotic development in India, strikes alliance with US firm SIGA Technologies. The partners are targeting novel antibacterials, especially against biothreats, and expect to cater to US agency BARDA, among others.

News and highlights of applications submitted for US FDA approval, from the Pink Sheet’s FDA Performance Tracker