BMJ22d
Comparative effectiveness and safety of single inhaler triple therapies for chronic obstructive pulmonary disease: new user cohort study
Objective To compare the effectiveness and safety of budesonide-glycopyrrolate-formoterol, a twice daily metered dose inhaler, and fluticasone-umeclidinium ... and unique brand-to-generic prescription ...
Scientific Research Publishing25d
Food and Drug Administration (1998) Reviewer Guidance: Nebulizers, Metered Dose Inhalers, Spacers, and Actuators.
ABSTRACT: The assessment of extractable and leachables (E&L) has become a cornerstone of pharmaceutical product safety, yet no unified global standards currently exist to quantify or report E&L from ...
New York Post28d
FDA approves Hikma’s generic version of Novo’s diabetes drug Victoza
The US Food and Drug Administration on Monday approved Hikma Pharmaceuticals’ generic version of Novo Nordisk’s diabetes drug, Victoza, clearing the way for the launch of another copy of the ...
ENDPOINTS NEWS28d
CMS ex­plains what went in­to its first round of drug price ne­go­ti­a­tions
The Cen­ters for Medicare and Med­ic­aid Ser­vices on Fri­day re­leased de­tailed but heav­i­ly redact­ed ex­pla­na­tions of how it de­ter­mined new prices for the first 10 … ...
JD Supra29d
Federal Circuit: Patent Must Claim Active Ingredient for Orange Book Listing
[23] The Federal Circuit noted that “the fact that the FDA approved Teva’s ProAir® HFA combination product as a drug does not make the inhaler’s device parts a drug. They are still devices ...