IMPAX Laboratories, Inc. (IPXL) Continues to Ignore FDA Warnings, Causing Delays
3/15/2013 7:03:03 AM
SAN DIEGO and HUNTERSVILLE, N.C., March 14, 2013 /PRNewswire/ -- Shareholder rights firm Robbins Arroyo LLP is investigating whether officers and directors of Impax Laboratories, Inc. (NASDAQ: IPXL) breached their fiduciary duties to shareholders by failing to correct the Company's inadequate quality controls and deficiencies in its manufacturing processes.
The FDA Notifies the Company of Its "Significant Violations of Current Good Manufacturing Practice Regulations"
On June 3, 2011, Impax received a warning letter from the Food and Drug Administration ("FDA") following an on-site inspection of Impax's Hayward, CA pharmaceutical manufacturing facility conducted between December 13, 2010 and January 21, 2011. In the warning letter, the FDA notified Impax of the company's "significant violations of Current Good Manufacturing Practice regulations for Finished Pharmaceuticals."
Continued Manufacturing Deficiencies Persist at Impax's Hayward Facility Delay Bringing Rytary to Market
On March 3, 2013, Impax announced the results of a subsequent FDA inspection of the Hayward Facility that included a re-inspection in connection with the May 2011 warning letter and a pre-approval inspection for the company's newly developed drug, Rytary. Following this inspection, the FDA issued a Form 483, "Notice of Inspectional Observances," documenting 12 problems, three of which were previously observed and noted in the 2011 warning letter. As a result of these continued manufacturing deficiencies, Impax has stated that it will be unable to bring Rytary to market before 2014. On this news, Impax's stock declined $5.20 per share, or 26%, to close at $14.80 per share on March 5, 2013.
Robbins Arroyo LLP highlights that Impax shareholders have the option to pursue a shareholder derivative action through which shareholders aim to hold insider wrongdoers accountable for their actions, prevent future misconduct, and bring long-term value back to the company. Concerned shareholders who would like more information about their rights and potential remedies can contact attorney Darnell R. Donahue at (800) 350-6003, DDonahue@robbinsarroyo.com, or via the shareholder information form on the firm's website.
Robbins Arroyo LLP is a nationally recognized leader in securities litigation and shareholder rights law. The firm represents individual and institutional investors in shareholder derivative and securities class action lawsuits, and has helped its clients realize more than $1 billion of value for themselves and the companies in which they have invested. For more information, please go to http://www.robbinsarroyo.com.
Press release link: http://www.robbinsarroyo.com/shareholders-rights-blog/impax-laboratories-inc/
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Darnell R. Donahue
Robbins Arroyo LLP
(619) 525-3990 or Toll Free at (800) 350-6003
SOURCE Robbins Arroyo LLP