Amphastar Pharmaceuticals, Inc. Announces Launch of Primatene® MIST to Nationwide Retail Pharmacies
January 03 2019 - 6:00AM
Amphastar Pharmaceuticals, Inc., (NASDAQ: AMPH) announced today
that Primatene® MIST has been launched. Primatene® MIST is an
epinephrine inhalation aerosol bronchodilator suspension, which is
the only FDA-approved metered dose inhaler (MDI) for asthma in the
over-the-counter (OTC) market in the United States. Primatene®
MIST is now available nationwide at Walgreens stores and online at
Walgreens and CVS. It will also be available nationwide at CVS
stores by mid-January. The Company is currently building additional
inventory to provide Primatene® MIST to more pharmacy chains and
big box retail stores in the coming months.
Pipeline Information
The Company currently has four abbreviated new
drug applications (“ANDAs”) filed with the FDA, which are
targeting products with a market size of approximately $0.7
billion, three biosimilar products in development targeting
products with a market size of approximately $14.0 billion,
and 11 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 September 30, 2018. The Company’s proprietary pipeline
includes an NDA for intranasal naloxone. The Company is currently
developing four other proprietary products, which include
injectable, inhalation and intranasal dosage forms.
Company Information
Amphastar is a specialty pharmaceutical company
that focuses on developing, manufacturing, marketing, and selling
technically-challenging generic and proprietary injectable,
inhalation and intra-nasal 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 is available
at the Company’s website at www.amphastar.com.
Amphastar’s logo and other trademarks or service
marks of Amphastar Pharmaceuticals, Inc., including, but not
limited to Primatene®, Amphadase® and Cortrosyn®, are the
property of Amphastar Pharmaceuticals, Inc.
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 DMFs, the timing of product launches and the
timing of products becoming available on the market,
acquisitions and other matters related to its current products,
pipeline of product candidates 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,
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. 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.
Investor Contact: Amphastar Pharmaceuticals,
Inc. Bill Peters Chief Financial Officer (909) 980-9484
Noted products are trademarks or registered trademarks of their
respective owners.
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