New Drug Application
FDA Accepts NDA for Acute Migraine Treatment
The FDA accepted a 505(b)(2) New Drug Application for a nasal spray for the acute treatment of migraine headaches ...
JANUARY 25, 2021
FDA to Review New Drug Application for Gout Drug
Duzallo is a once-daily, fixed-dose combination of lesinurad and allopurinol for the treatment of hyperuricemia ...
JANUARY 4, 2017
FDA Advisory Committee Recommends Approval of Buprenorphine Implant for Opioid Addiction
Probuphine can provide up to six months of sustained delivery of the opioid partial agonist buprenorphine when four ...
JANUARY 14, 2016
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