FDA rejects Recro Pharma new drug application for a non-opioid pain medicine
The Food and Drug Administration rejected a new drug application submitted by Recro Pharma for its new drug candidate, a non-opioid pain medicine.
The action sent the Malvern specialty pharmaceutical company's stock plunging by more than 50 percent to $6.14 in pre-market trading.
In the complete response letter the FDA sent to Recro Pharma (NASDAQ: REPH), the FDA said it is unable to approve the application for IV meloxicam in its current f orm. IV Meloxicam is an intravenous formulation of an oral…
Source: bizjournals.com Health Care:Physician Practices headlines - Category: American Health Authors: John George Source Type: news
More News: American Health | Food and Drug Administration (FDA) | Health Management | Meloxicam | Mobic | New Drug Applications | Pain | Pharmaceuticals