Amphastar Pharmaceuticals Receives FDA Approval for Atropine Sulfate Injection
October 06 2020 - 6:00AM
Amphastar Pharmaceuticals, Inc. (NASDAQ: AMPH) announced that the
U.S. Food and Drug Administration (“FDA”) approved the Company’s
Abbreviated New Drug Application (“ANDA”) for Atropine Sulfate
injection 0.1mg/mL in the 10 mL Luer-Jet® Prefilled Syringe System.
For the past 40 years, the Company has sold and marketed the
product under the “grandfather” exception (now termed “unapproved”)
to the FDA’s “Prescription Drug Wrap-Up” program. Net revenues for
the Company’s Atropine Sulfate injection for the year ended
December 31, 2019 were $12.2 million.Amphastar’s CEO and President,
Dr. Jack Zhang, commented: “The FDA’s approval of our Atropine
Sulfate product, a product often on the Agency’s Drug Shortage
list, offers an opportunity to ensure quality products are produced
at the highest standard and highlights Amphastar’s manufacturing
capacity to fulfill such market needs.”
Pipeline
InformationThe Company currently has four ANDAs filed with
the FDA, which are targeting products with a market size of
approximately $1.5 billion, three biosimilar products in
development targeting products with a market size
of approximately $13.0 billion, and nine generic products in
development targeting products with a market size of
approximately $12.0 billion. This market information is based
on IQVIA data for the 12 months ended June 30, 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
InformationAmphastar 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 Mist®, Amphadase®, and
Cortrosyn®, are the property of Amphastar.
Forward-Looking
StatementsAll 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 PetersChief
Financial Officer(909) 980-9484
Amphastar Pharmaceuticals (NASDAQ:AMPH)
Historical Stock Chart
From Mar 2024 to Apr 2024
Amphastar Pharmaceuticals (NASDAQ:AMPH)
Historical Stock Chart
From Apr 2023 to Apr 2024