LONDON, March 30 (Reuters) - GlaxoSmithKline's new CEO Emma Walmsley, who takes over on April 1, has won a short-term reprieve from the threat of generic Advair with a delay in U.S. approval for Mylan ...
Lannett has submitted an ANDA to the Food and Drug Administration for its strategic partner, Respirant's fluticasone propionate and salmeterol inhalation powder (100/50 mcg, 250/50 mcg and 500/50 mcg) ...
The Food and Drug Administration has accepted Lannett’s abbreviated new drug application for fluticasone propionate and salmeterol inhalation powder in three strengths — a generic of GlaxoSmithKline's ...
LONDON (Reuters) - A deadline for U.S. regulators to give a verdict on a generic copy of GlaxoSmithKline's (GSK.L) blockbuster inhaled lung drug Advair has passed with no sign of approval, sparking ...
US regulators have upheld a prior decision rejecting Hikma and Vectura’s generic formulation of GlaxoSmithKline's asthma and chronic obstructive pulmonary syndrome therapy Advair Diskus. US regulators ...