FDA Pulmonary Hypertension Patient Meeting Follows Two Recent Approvals
This article was originally published in The Pink Sheet Daily
Executive Summary
In announcing the May 13 meeting, FDA asks whether pulmonary arterial hypertension medications have made a difference to patients with the condition.
You may also be interested in...
United Therapeutics To Price Oral Treprostinil On Par With Other Formulations
FDA labeling for just-approved pulmonary arterial hypertension drug Orenitram (treprostinil) suggests the oral drug could replace United Therapeutics’ other formulations, though it was not specifically studied for that. Company says it was surprised by the approval, which came well ahead of the user fee date, and plans to launch in six months.
Puberty Blockers: FDA's Califf Asked If REMS, Boxed Warning Against Off-Label Use In The Works
FDA Commissioner Robert Califf tells House appropriations subcommittee chair the agency will 'consider any information that may be available' on off-label use of puberty blockers for gender dysphoria before making a regulatory decision.
ADHD Drugs: FDA Commissioner Blames Inappropriate Prescribing For Shortages
ADHD drug shortages may have resulted from industry reticence to fill DEA quotas, as well as a 'heavy element of professional responsibility' with off-label prescribing, Robert Califf told a House appropriations subcommittee.