Amneal Parkinson’s drug IPX203 needs to compete with novel subcutaneous levodopa delivery systems…
Amneal’s IPX203 is an oral extended-release (ER) capsule formulation of levodopa that is designed to sustain levodopa plasma…
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Browsing Tag
CRL
Avenue Therapeutics receives complete response letter from the FDA for IV Tramadol
The CRL stated that IV tramadol, intended to treat patients in acute pain who require an opioid, is not safe for the intended…
US FDA denies approval for Tricida’s Veverimer
Veverimer (TRC101), a non-absorbed, orally-administered polymer, is designed to treat metabolic acidosis in patients with chronic…
SPARC licenses Xelpros to Sun Pharma
In December 2014, the US FDA had issued a Complete Response letter (CRL) to SPARC for its New Drug Application (NDA) for…