(OTCBB:ABRX), Able Laboratories Receives FDA Approval for Prochlorperazine Suppositories USP,
2.5 Mg, 5 Mg and 25 Mg
Business Editors/Health & Medical Writers
SOUTH PLAINFIELD, N.J.--(BUSINESS WIRE)--July 13, 2001--
-- The Only Company to Offer Generic Version of
Compazine(R) in All Three Strengths --
Able Laboratories, Inc. today announced it has
received Food and Drug Administration (FDA) approval for its
Abbreviated New Drug Application (ANDA) for Prochlorperazine
suppositories USP, 2.5 mg, 5 mg and 25 mg. The approval followed the
FDA's Division of Bioequivalence's determination that Able's
Prochlorperazine suppositories USP, 2.5 mg, 5 mg and 25 mg, are
bioequivalent and, therefore, therapeutically equivalent to the
Compazine(R) suppositories 2.5 mg, 5 mg and 25 mg of Smithkline
Beecham Pharmaceuticals. The generic market for Able's newly approved
drug, a suppository used primarily to treat severe nausea and
vomiting, is estimated to be $18 million by IMS Data.
"Suppositories are challenging formulations and we are extremely
pleased to have developed the technology and experience to formulate
these types of dosage forms," commented Jay Wadekar, President and
Chief Operating Officer of Able Laboratories, Inc. "One of our
research and development strategies is to focus on specific areas that
utilizes our technological expertise and will produce products that
possess high margins. Our new approval fits perfectly in this niche."
"We are extremely pleased to receive our second FDA approval in
two days," stated C. Robert Cusick, Chairman and Chief Executive
Officer of Able Laboratories, Inc. "Today's announcement follows our
receipt yesterday of FDA approval for our generic version of
Darvocet-N(R). In addition, we have now obtained ANDA approvals for
generic versions of Ritalin SR(R), Ritalin(R), Lomotil(R), Soma(R) and
Darvocet-N(R) and one New Drug Application (NDA) approval. The total
market for our recently approved products is estimated at $1.2 billion
by IMS Data. Additionally, we currently have eight ANDAs pending
approval, several of which we anticipate within the next few months."
Able Laboratories (OTCBB:ABRX) is a rapidly growing developer and
manufacturer of generic pharmaceuticals. Able's focus is to develop
products that offer attractive market opportunities within selected
niche markets of the generic drug industry. In addition to the one new
drug application approval that the company recently received, it has
obtained seven ANDA approvals and has several ANDAs in various stages
of FDA approval. Able has recently completed its transition to focus
the company's activities solely on generic drug development,
manufacturing and sales by divesting its distribution subsidiaries.
The Private Securities Litigation Reform Act of 1995 provides a
"safe harbor" for forward-looking Statements. Certain information
included in this news release (as well as information included in oral
statements or other written statements made or to be made by Able
Laboratories, Inc. f/k/a DynaGen, Inc.) contain statements that are
forward-looking, such statements relate to anticipated future revenues
of the company success of current product offerings, research and
development efforts and the timeliness of Food and Drug Administration
(FDA) filings and approvals. There is no assurance that the company
will achieve the sales levels that will make the operation profitable
or that FDA filings and approvals will be completed as anticipated.
Such forward-looking information involves important risks and
uncertainties that could significantly affect anticipated results in
the future and accordingly, such results may differ materially from
those expressed in any forward-looking statements made by or on behalf
of Able Laboratories, Inc. f/k/a DynaGen, Inc. For a description of
additional risks, and uncertainties, please refer to Able
Laboratories, Inc. f/k/a DynaGen, Inc. filings with the Securities and
Exchange Commission, including Forms 10 -KSB and 10-Q.
Compazine is a registered trademark of Smithkline Beecham
Pharmaceuticals.
Darvocet-N is a registered trademark of Eli Lilly.
Lomotil is a registered trademark of G. D. Searle
Ritalin and Ritalin SR are registered trademarks of Novartis
Soma is a registered trademark of Wallace Laboratories
--30--cp/mi*
CONTACT: Able Laboratories, Inc., South Plainfield
Catherine M. Frost, 978/282-0065
or
Investor Relations, Inc.
Gary Frank, 386/409-0200
:=) Gary Swancey
AI
