Diversity in ANDA Studies Questioned
Earlier this month, Vanda submitted a Citizen Petition asking FDA to revoke the approval of Teva’s ANDA product for Hetlioz®(tasimelteon) Capsules, the sleep disorder drug. Vanda also asks FDA to remove the Teva product from the market. This Petition comes after Vanda lost its PIV case in December which case is pending appeal. (Citizen Petition: … Continue reading →