Zingo
lidocaine hydrochloride monohydrate
Treatment for Local AnesthesiaEndo Comments on Notices Received From Anesiva Regarding Zingo
Endo Comments on Notices Received From Anesiva Regarding Zingo
CHADDS FORD, PA, Apr 10, 2007 (MARKET WIRE via COMTEX News Network) -- Endo Pharmaceuticals Inc., a wholly owned subsidiary of Endo Pharmaceuticals Holdings Inc. (NASDAQ: ENDP), announced today that it received notice from Anesiva, Incorporated, advising of the filing of a New Drug Application (NDA) under 21 U.S.C. Section 355(b)(2)(A)(iv) (also referred to as Section 505 (b)(2)(A)(iv) of the Federal Food, Drug and Cosmetic Act) for its Zingo Dermal PowderJect Lidocaine HCl topical powder and referring to the patents that cover the method of use and formulation of Endo's lidocaine-containing topical patch products, Lidoderm and Synera.
Section 505(b)(2) does not allow for automatic generic substitution
of these prescription products for any other products.
If approved, Endo believes that Zingo will not be a generic to, nor
will it compete with, Lidoderm because of Zingo's indication and
formulation. Anesiva's notice stated that Zingo's proposed
indication is for preventing or reducing pain associated with blood
draws and intravenous placements. Unlike Lidoderm, Zingo is not
a topical patch. However, Endo believes that, although Zingo would
not be a substitutable generic to Synera and uses a different
delivery mechanism, Zingo may compete with Synera because their
indications may be similar. Endo will continue to evaluate these
notices.
According to Anesiva's notice letter, Zingo's injection device drives lidocaine powder into the skin surface using accelerated inert gas particles. An NDA for Zingo was filed in late 2006 and accepted for filing in January 2007.
About Endo
Endo Pharmaceuticals Holdings Inc. is a fully integrated specialty pharmaceutical company with market leadership in pain management products. Through its Endo Pharmaceuticals Inc. subsidiary, the company researches, develops, produces and markets a broad product offering of both branded and generic pharmaceuticals, meeting the needs of healthcare professionals and consumers alike. More information, including this and past press releases of Endo Pharmaceuticals Holdings Inc., is available online at www.endo.com.
Forward-Looking Statements
This press release contains forward-looking statements, within
the meaning of Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Exchange Act of 1934, as amended,
that are based on management's beliefs and assumptions, current
expectations, estimates and projections. Statements that are not
historical facts, including statements which are preceded by,
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forward-looking statements. Endo's estimated or anticipated future
results, product performance or other non-historical facts are
forward-looking and reflect Endo's current perspective on existing
trends and information. Many of the factors that will determine the
Company's future results are beyond the ability of the Company to
control or predict. These statements are subject to risks and
uncertainties and, therefore, actual results may differ materially
from those expressed or implied by these forward-looking
statements. The reader should not rely on any forward-looking
statement. The Company undertakes no obligation to update any
forward-looking statements whether as a result of new information,
future events or otherwise. Several important factors, in addition
to the specific factors discussed in connection with these
forward-looking statements individually, could affect the future
results of Endo and could cause those results to differ materially
from those expressed in the forward-looking statements contained in
this press release. Important factors that may affect future
results include, but are not limited to: market acceptance of the
Company's products and the impact of competitive products and
pricing; dependence on sole source suppliers; the success of the
Company's product development activities and the timeliness with
which regulatory authorizations and product launches may be
achieved; successful compliance with extensive, costly, complex and
evolving governmental regulations and restrictions; the
availability on commercially reasonable terms of raw materials and
other third party manufactured products; exposure to product
liability and other lawsuits and contingencies; dependence on third
party suppliers, distributors and collaboration partners; the
ability to timely and cost effectively integrate acquisitions;
uncertainty associated with pre-clinical studies and clinical
trials and regulatory approval; uncertainty of market acceptance of
new products; the difficulty of predicting FDA approvals; risks
with respect to technology and product development; the effect of
competing products and prices; uncertainties regarding intellectual
property protection; uncertainties as to the outcome of litigation;
changes in operating results; impact of competitive products and
pricing; product development; changes in laws and regulations;
customer demand; possible future litigation; availability of future
financing and reimbursement policies of government and private
health insurers and others; and other risks and uncertainties
detailed in Endo's filings with the Securities and Exchange
Commission, including its Registration Statement on Form 10-K filed
with the SEC on March 1, 2007. Readers should evaluate any
statement in light of these important factors.
SOURCE: Endo Pharmaceuticals
Related Articles:
Anesiva Announces FDA Approval of sNDA to Expand Zingo Indication to Include Adults - January 9, 2009
Anesiva Receives FDA Approval for Zingo, a New, Innovative Product to Reduce Pain Associated with Needle Insertion Procedures in Children - August 17, 2007
Anesiva Announces FDA Acceptance for Filing of Zingo New Drug Application to Reduce Pain Associated With Needle Insertion Procedures in Children - February 7, 2007
Anesiva Announces Filing of New Drug Application for Zingo to Reduce Pain Associated with Needle Insertion Procedures in Children - November 27, 2006
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