Pacira

Where is this shit coming firm? This thread is like from 20 up years ago. I don't believe your story. Anesthesiologists have always been a primary target. Take a deep breath. You didn't make the cut during the interview process. Move on and get over it!

 

Pacira Pharmaceuticals, Inc. Announces Receipt of FDA Warning Letter

PARSIPPANY, N.J.--(BUSINESS WIRE)--Sep. 25, 2014-- Pacira Pharmaceuticals, Inc. (NASDAQ: PCRX) today announced the receipt of a Warning Letter (attached for reference) from the U.S. Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) referencing certain promotional materials on EXPAREL® (bupivacaine liposome injectable suspension).

 

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Pacira Pharmaceuticals, Inc. - PCRX

NEW YORK, Sept. 25, 2014 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of Pacira Pharmaceuticals, Inc. ("Pacira" or the "Company") (PCRX). Such investors are advised to contact Robert S. Willoughby at rswilloughby@pomlaw.com or 888-476-6529, ext. 237.

The investigation concerns whether Pacira and certain of its officers and/or directors have violated Sections 10(b) and 20(a) of the Securities Exchange Act of 1934.

On September 25, 2014, the Company announced that it received a Warning Letter from the U.S. Food and Drug Administration's ("FDA") Office of Prescription Drug Promotion referencing certain promotional materials for EXPAREL® (bupivacaine liposome injectable suspension), an injectable drug that numbs post-surgical pain.

In the letter, the FDA said Pacira promotes its drug EXPAREL as being able to work for up to 72 hours when it has only been approved for 24-hour pain relief. "These claims overstate Exparel's efficacy and are misleading," the FDA said in the letter.

On this news, shares of Pacira fell $4.70 per share to $101.58, or more than 4.42%, in intraday trading on September 25, 2014.

The Pomerantz Firm, with offices in New York, Chicago, San Diego and Florida, is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, the Pomerantz Firm pioneered the field of securities class actions. Today, more than 70 years later, the Pomerantz Firm continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomerantzlaw.com.

CONTACT:
Robert S. Willoughby
Pomerantz LLP
rswilloughby@pomlaw.com

 

On 12/15/15 the FDA rescinded its 9/22/14 Warning Letter. Ths rescision etter was issued by the FDA's Janet Woodcock, MD, Director of thecCenter for Drug Evalustion and Research (CDER).

The FDA confirmed the broad indication for EXPAREL. "EXPAREL is indicated forvadministration into the surgical site tobproducevpost-surgical analgesia. Rosing isvbased on:
1. Size of surgical site
2. Volume required to cover surgicalnsite
3. Individual patient factors
4. Maximum dose 266 mg/one vial (20ml)

The FDA also rewrote the EXPAREL Package Insert. The FDA also confirmed admixing, dosing clarity, use as a field block, and duration of efficacy.

To quote the FDA rescission letter, "The United States confirms that EXPAREL has, since October 28, 2011, been approved for 'administration into thevsurgicsl site ton produce postdoctoral analgesia' for use in a variety of surgeries not limited those studied in it's pivotal trials."

All this information, and more, is available on Pacira web site.

 

Corrected, tough to edit on cell phone.


On 12/15/15 the FDA rescinded its 9/22/14 Warning Letter. The rescission letter was issued by the FDA's Janet Woodcock, MD, Director of the Center for Drug Evalustion and Research (CDER).

The FDA confirmed the broad indication for EXPAREL. "EXPAREL is indicated for administration into the surgical site to produce postsurgical analgesia. Dosing is based on:
1. Size of surgical site
2. Volume required to cover surgical site
3. Individual patient factors
4. Maximum dose 266 mg/one vial (20ml)

The FDA also rewrote the EXPAREL Package Insert. The FDA also confirmed admixing, dosing clarity, use as a field block, and duration of efficacy.

To quote the FDA rescission letter, "The United States confirms that EXPAREL has, since October 28, 2011, been approved for 'administration into the surgicsl site to produce postsurgicsl analgesia' for use in a variety of surgeries not limited those studied in it's pivotal trials."

All this information, and more, is available on Pacira web site.[/QUOTE]