Expanded use of MYOVIEW close to approval:
This article was originally published in Clinica
Nycomed Amersham Imaging has received an approvable letter from the US FDA for the additional use of its MYOVIEW radiopharmaceutical with pharmacologic stress agents, which are specifically used in the diagnosis of coronary artery diseases in patients unable to exercise physically. The letter comes 10 months after the initial submission. MYOVIEW was launched in the US in 1996 and has a 30% share of the US technetium cardiac market, says the product's Princeton, New Jersey-based developer.
You may also be interested in...
Oncology Center of Excellence is reviewing a research report on fluorouracil, and will next look to update cisplatin's label, but eventually must convince the reference product sponsor to submit the changes.
US FDA’s ‘Project Renewal’ requires lots of work and flexibility, Oncology Center of Excellence acknowledges. Side-benefit may be getting outside physicians to appreciate the value of drug labeling.
The pharmaceutical industry would lose bid to eliminate PUPSIT but win relaxed WFI in proposed EU GMP Annex I revision.