Pacira Pharmaceuticals Statement on FDA Advisory Committee for EXPAREL® for Use as a Nerve Block to Produce Regional Analgesia
Pacira BioSciences, Inc. (PCRX)
Last pacira biosciences, inc. earnings: 2/20 08:00 am
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Source: GlobeNewswire
PARSIPPANY, N.J., Feb. 15, 2018 (GLOBE NEWSWIRE) -- Pacira Pharmaceuticals, Inc. (NASDAQ:PCRX), announced today that the U.S. Food and Drug Administration’s (FDA) Anesthetic and Analgesic Drug Products Advisory Committee did not reach a unanimous decision on the efficacy and safety of the use of EXPAREL® (bupivacaine liposome injectable suspension) as a nerve block to produce regional analgesia. The committee’s feedback will be considered by the FDA in its review of the company’s sNDA seeking expansion of the EXPAREL label. The Prescription Drug User Fee Act (PDUFA) date for completion of the review is April 6, 2018. Four committee members voted to recommend FDA approval of the EXPAREL sNDA while six believed that more research is needed to further support the proposed new indication. “We remain confident that the data from our clinical program provides all of the necessary information to support expansion of the current EXPAREL label for infiltration to also include use as a n
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News
- Pacira BioSciences, Inc. (NASDAQ: PCRX) had its price target lowered by analysts at Needham & Company LLC from $45.00 to $43.00. They now have a "buy" rating on the stock.MarketBeat
- Here's What Key Metrics Tell Us About Pacira (PCRX) Q1 Earnings [Yahoo! Finance]Yahoo! Finance
- Pacira BioSciences Reports First Quarter 2024 Financial Results and Announces $150 Million Share Repurchase program [Yahoo! Finance]Yahoo! Finance
- Pacira BioSciences Reports First Quarter 2024 Financial Results and Announces $150 Million Share Repurchase programGlobeNewswire
- Pacira BioSciences to Participate in Fireside Chat at the 2024 RBC Capital Markets Global Healthcare ConferenceGlobeNewswire
PCRX
Earnings
- 5/7/24 - Beat
PCRX
Sec Filings
- 5/7/24 - Form 10-Q
- 5/7/24 - Form 8-K
- 4/22/24 - Form ARS
- PCRX's page on the SEC website