Amphastar Pharmaceuticals, Inc. Receives FDA Approval for Succinylcholine Chloride Injection USP, 200 mg/10 mL (20 mg/mL) Mul...
June 09 2020 - 06:00AM
Amphastar® Pharmaceuticals, Inc., (NASDAQ: AMPH) (“Amphastar”),
today announces that the U.S. Food and Drug Administration (“FDA”)
has approved its Abbreviated New Drug Application (“ANDA”) for
Succinylcholine Chloride Injection USP, 200 mg/10 mL (20 mg/mL)
Multiple-Dose Vial. Amphastar’s newly approved drug product was
determined by the FDA to be therapeutically equivalent to Quelicin™
(Succinylcholine Chloride Injection USP, 200 mg/10 mL (20 mg/mL)
Multiple-Dose Vial) distributed in the United States by Pfizer,
Inc. Succinylcholine Chloride Injection is for intramuscular and
intravenous use. It is indicated as an adjunct to general
anesthesia, to facilitate tracheal intubation, and to provide
skeletal muscle relaxation during surgery or mechanical
ventilation.
Amphastar’s CEO and President, Dr. Jack Zhang, commented: “We
would like to thank the FDA review team for working diligently and
approving this application in its first review cycle. This approval
highlights the strengths of our quality systems and regulatory
capabilities in pipeline development.”
According to IQVIA™, U.S market annual sales for the 12 months
ended March 31, 2020 for Succinylcholine Chloride Injection USP,
200 mg/10 mL (20 mg/mL) Multiple-Dose Vial was approximately $75
million.
Pipeline Information
The Company currently has five ANDAs filed with the FDA,
which are targeting products with a market size of
approximately $1.7 billion, three biosimilar products in
development targeting products with a market size
of approximately $13 billion, and nine generic products in
development targeting products with a market size of
approximately $12 billion. This market information is based
on IQVIA data for the 12 months ended March 31,
2020. The Company is developing multiple proprietary pipeline
products for injectable and intranasal dosage forms, including a
new drug application for intranasal naloxone.
Amphastar’s Chinese subsidiary, ANP, currently has 14 Drug
Master Files, or DMF, on file with the FDA and is developing
several additional DMFs.
Company Information
Amphastar is a specialty pharmaceutical company
that focuses primarily on developing, manufacturing, marketing, and
selling technically-challenging generic and proprietary injectable,
inhalation, and intranasal products. Additionally, the Company
sells insulin API products. Most of the Company’s finished
products are used in hospital or urgent care clinical settings and
are primarily contracted and distributed through group purchasing
organizations and drug wholesalers. More information and
resources are available at www.amphastar.com.
Amphastar’s logo and other trademarks or service
marks of Amphastar, including, but not limited to Amphastar®,
Primatene®, Amphadase® and Cortrosyn®, are the property of
Amphastar.
Forward-Looking Statements
All statements in this press release that are not historical are
forward-looking statements, including, among other things,
statements relating to the Company’s expectations regarding future
financial performance, backlog, sales and marketing of its
products, market size and growth, the timing of FDA filings or
approvals, including the DMFs of ANP, the timing of product
launches, acquisitions and other matters related to its pipeline of
product candidates, its share buyback program and other future
events. These statements are not historical facts but rather are
based on Amphastar’s historical performance and its current
expectations, estimates, and projections regarding Amphastar’s
business, operations, and other similar or related factors. Words
such as “may,” “might,” “will,” “could,” “would,” “should,”
“anticipate,” “predict,” “potential,” “continue,” “expect,”
“intend,” “plan,” “project,” “believe,” “estimate,” and other
similar or related expressions are used to identify these
forward-looking statements. However, not all forward-looking
statements contain these words. You should not place undue reliance
on forward-looking statements because they involve known and
unknown risks, uncertainties, and assumptions that are difficult or
impossible to predict and, in some cases, beyond Amphastar’s
control. Actual results may differ materially from those in
the forward-looking statements as a result of a number of factors,
including those described in Amphastar’s filings with the
Securities and Exchange Commission. You can locate these reports
through the Company’s website at http://ir.amphastar.com and on the
SEC’s website at www.sec.gov. Amphastar undertakes no
obligation to revise or update information in this press release to
reflect events or circumstances in the future, even if new
information becomes available or if subsequent events cause
Amphastar’s expectations to change.
Noted products are trademarks or registered trademarks of their
respective owners.
Contact Information: Amphastar Pharmaceuticals, Inc. Bill
Peters Chief Financial Officer (909) 980-9484
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