Category: Middle East and North Africa

November 27, 2019 Off

HIkma responds to FDA about GSK’s Advair Diskus

By Dino Mustafić

Hikma has submitted to the US Food and Drug Administration (FDA) its response to deficiencies in its abbreviated new drug application (ANDA) for a generic version of GlaxoSmithKline’s Advair Diskus® (fluticasone propionate and salmeterol inhalation powder).

September 5, 2019 Off

Teva to Present New Analyses of Fremanezumab Efficacy and Safety in Adult Patients with Difficult-to-Treat Migraine at 19th Congress of the International Headache Society

By BusinessWire

Late breaking data examines 10-year cost effectiveness of fremanezumab, while one oral presentation and 29 posters highlight FOCUS Phase IIIb study data in adult patients with migraine and documented inadequate response to 2-4 classes of prior preventive treatments, along with patient survey results and post hoc efficacy results following the 1-year Phase III HALO long-term study