Amphastar Announces Approval for Neostigmine Methylsulfate Injection, USP
September 25 2017 - 6:51PM
Amphastar Pharmaceuticals, Inc., (NASDAQ:AMPH) announced that the
U.S. Food and Drug Administration (“FDA”) granted approval of its
abbreviated new drug application (ANDA) for Neostigmine
Methylsulfate Injection, USP, 1mg/mL, 10mL, and 0.5mg/mL, 10mL
vial. Amphastar’s newly approved product was determined by the FDA
to be therapeutically equivalent to Bloxiverz® sold in the United
States by Avadel, with the same active ingredients, route of
administration, strength and dosage form.
Amphastar's CEO, Dr. Jack Zhang, stated: "We are excited about
the approval of Neostigmine Methylsulfate Injection, which expands
the product offerings of our generic injectable portfolio.”
According to IMS Health data, U.S. brand and generic sales of
Neostigmine Methylsulfate Injection, USP, 1mg/mL, 10mL, and
0.5mg/mL, 10 mL were approximately $185 million for the 12 months
ended June 30, 2017.
Amphastar anticipates launching its product in the fourth
quarter of 2017.
Pipeline Information
The Company currently has five abbreviated new drug
applications, or ANDAs filed with the FDA, targeting products with
a market size of over $0.9 billion, three biosimilar products in
development targeting products with a market size of $15.0 billion,
and 11 generic products in development targeting products with a
market size of over $12.0 billion. This market information is based
on IMS Health data for the 12 months ended June 30, 2017. The
Company’s proprietary pipeline includes NDAs for Primatene® Mist
and intranasal naloxone. The Company is currently developing other
proprietary products, which include injectable, inhalation and
intranasal dosage forms.
Company Information Amphastar is a specialty
pharmaceutical company that focuses primarily on developing,
manufacturing, marketing, and selling technically-challenging
generic and proprietary injectable and inhalation products. In
2014, the Company also commenced sales of insulin active
pharmaceutical ingredient 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.
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 regulatory filings or
approvals 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 current expectations, estimates, and projections
regarding Amphastar’s business, operations, and other similar or
related factors. Words such as “may,” “will,” “could,” “would,”
“should,” “anticipate,” “predict,” “potential,” “continue,”
“expects,” “intends,” “plans,” “projects,” “believes,” “estimates,”
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. 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.
Contact Information: Amphastar
Pharmaceuticals, Inc.Bill PetersChief Financial Officer(909)
980-9484
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