Amphastar Pharmaceuticals Receives FDA Approval for Morphine Sulfate Injection
03 Mayo 2021 - 5:00AM
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 Morphine
Sulfate injection 1mg/mL in the 30mL Pump-Jet® Prefilled
Syringe System. It is indicated for the management of pain severe
enough to require use of an opioid analgesic by Patient-Controlled
Analgesia (PCA), only for use with a compatible Alaris® infusion
device, and for which alternative treatments are inadequate. For
the past 30 years, the company has sold and marketed the product
under the “grandfather” exception to the FDA’s “Prescription Drug
Wrap-Up” program. Net revenues for the Company’s Morphine injection
for the year ended December 31, 2020, were $2.3 million.
Amphastar’s CEO and President, Dr. Jack Zhang, commented:
“The FDA’s approval of Morphine injection shows the Company’s
continued commitment and ability to manufacture high quality
injection products.”
Pipeline Information
The Company currently has five ANDAs on file with the FDA
targeting products with a market size of approximately $2.4
billion, three biosimilar products in development targeting
products with a market size of approximately $13 billion, and seven
generic products in development targeting products with a market
size of approximately $10 billion. This market information is based
on IQVIA data for the 12 months ended March 31, 2021. The Company
is currently developing multiple proprietary products with
injectable and intranasal dosage forms.
Amphastar’s Chinese subsidiary, ANP, currently has 17 Drug
Master Files, or DMFs, on file with the FDA and is developing
several additional DMFs.
Company Information
Amphastar is a bio-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 Statements
All statements in this press release and in the conference call
referenced above 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, product development, 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, such as the impact of the COVID-19 pandemic and related
responses of business and governments to the pandemic on our
operations and personnel, and on commercial activity and demand
across our business operations and results of operations. 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,
although 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, including in
the Annual Report on Form 10-K for the year ended December 31,
2020, filed with the SEC on March 15, 2021. In particular, the
extent of COVID-19’s impact on our business will depend on several
factors, including the severity, duration and extent of the
pandemic, as well as actions taken by governments, businesses, and
consumers in response to the pandemic, all of which continue to
evolve and remain uncertain at this time. 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. The forward-looking statements in this release speak
only as of the date of the release. Amphastar undertakes no
obligation to revise or update information or any forward-looking
statements in this press release or the conference call referenced
above 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)
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