I’ve always thought that the timing of the slow, lingering FDA fiasco with Midodrine was odd, since it coincided with Chelsea Theraputics’ trying to get that Northera orthostatic hypotension drug to market. Chelsea Theraputics’ previous clinical studies on Northera didn’t do well this year UPDATE 2-Chelsea Therapeutics shares fall on Northera study data (Reuters) so they redesigned the studies.
This week shares were up:
Chelsea Therapeutics asks FDA to approve Northera
Their application is being fast-tracked for FDA approval within 60 days, LOL.
From what I understand, Northera crosses the blood-brain barrier, while Midodrine does not.
- A drug in limbo, Catch-22 for FDA ← ← ← Midodrine
- Shire Provides Update on ProAmatine® (midodrine HCl) ← ← ← Midodrine
- Midodrine Exclusivity Issues Docket ID: FDA-2007-N-0475 ← ← ← Midodrine This is the FDA docket on Midodrine @ regulations.gov. The FDA finally responded to Shire after over 1 year
- Shire seeks hearing to break impasse on Proamatine ← ← ← Midodrine
- She dates a series of insensitive men before finding Michael, who once spotted portable heat wraps on sale at Costco and bought her an entire pallet—300 boxes.
- CHTP investors still hoping FDA pulls midodrine; other catalyst on tap this month ← ← ← Midodrine
- Milo man with rare syndrome faces life of pain
- Positively Milwaukee – Building compassion
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