NDA
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 Accepts sNDA Filing for Capsaicin Patch DPNP Indication
The FDA has accepted a supplemental New Drug Application for capsaicin 8% patch for the treatment of neuropathic ...
JANUARY 15, 2020
FDA Accepts NDA Resubmission for Bupivacaine-Meloxicam Combination for Postoperative Pain
The FDA accepted a New Drug Application resubmission for HTX-011, an investigational agent for the management of ...
NOVEMBER 4, 2019
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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