Pacira Pharmaceuticals, Inc. Announces Receipt of FDA Warning Letter
“We take regulatory compliance very seriously and believe that our
current labeling supports the claims being challenged by the FDA,” said
EXPAREL is indicated for single-dose infiltration into the surgical site to produce postsurgical analgesia in adult patients 18 years of age or older.
About Pacira
About EXPAREL®
EXPAREL (bupivacaine liposome injectable suspension) is indicated for single-dose infiltration into the surgical site to produce postsurgical analgesia. The product combines bupivacaine with DepoFoam, a proven product delivery technology that delivers medication over a desired time period. EXPAREL represents the first and only multivesicular liposome local anesthetic that can be utilized in the peri- or postsurgical setting in the same fashion as current local anesthetics. By utilizing the DepoFoam platform, a single dose of EXPAREL delivers bupivacaine over time, providing analgesia with reduced opioid requirements for up to 72 hours.
Forward Looking Statements
Any statements in this press release about our future expectations,
plans and prospects, including statements about our plans and
expectations regarding EXPAREL, and other statements containing the
words “believes,” “anticipates,” “plans,” “expects,” and similar
expressions, constitute forward-looking statements within the meaning of
The Private Securities Litigation Reform Act of 1995. Actual results may
differ materially from those indicated by such forward-looking
statements as a result of various important factors, including risks
relating to: our ability to adequately resolve the issues raised in the
FDA’s warning letter; our and Patheon’s ability to successfully and
timely construct dedicated EXPAREL manufacturing suites; the success of
our sales and manufacturing efforts in support of the commercialization
of EXPAREL; the rate and degree of market acceptance of EXPAREL; the
size and growth of the potential markets for EXPAREL and our ability to
serve those markets; our plans to expand the indications of EXPAREL,
including for nerve block and the related timing and success of an sNDA;
our plans to evaluate, develop and pursue additional DepoFoam-based
product candidates; clinical studies in support of an existing or
potential DepoFoam-based product; our plans to continue to manufacture
and provide support services for our commercial partners who have
licensed DepoCyt(e); our commercialization and marketing capabilities;
and other factors discussed in the “Risk Factors” of our most recent
Annual Report on Form 10-K for the fiscal year ended
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Source:
Pacira Pharmaceuticals, Inc.
Company Contact:
Jessica Cho,
973-254-3574
Jessica.Cho@pacira.com
or
Pure
Communications, Inc.
Media Contact:
Susan Heins, 864-286-9597
sjheins@purecommunicationsinc.com