Amphastar Announces Approval for Sodium Nitroprusside Injection, USP
December 19 2017 - 6:00AM
Amphastar Pharmaceuticals, Inc., (NASDAQ: AMPH) announced that
today the U.S. Food and Drug Administration (“FDA”) granted
approval of its abbreviated new drug application (“ANDA”) for
Sodium Nitroprusside Injection 25mg/mL, 2mL single dose vial,
indicated for the immediate reduction of blood pressure of adult
and pediatric patients in hypertensive crisis. The product is also
indicated for producing controlled hypotension in order to reduce
bleeding during surgery and for the treatment of acute congestive
heart failure. Amphastar’s newly approved product was determined by
the FDA to be therapeutically equivalent to Nitropress® (Sodium
Nitroprusside Injection) sold in the United States by Valeant
Pharmaceuticals.
Amphastar's CEO, Dr. Jack Zhang, stated: "We are excited about
the approval of Sodium Nitroprusside Injection, which further
expands the product offerings in our generic injectable portfolio,
and further strengthens our vertical integration strategy, given
that the Active Pharmaceutical Ingredient for this product is
manufactured by ANP, our subsidiary in China."
According to IQVIA, U.S. brand and generic sales of Sodium
Nitroprusside Injection, 25 mg/mL, 2mL vials were approximately
$73.8 million for the 12 months ended September 30, 2017.
Amphastar anticipates launching its product in the first quarter
of 2018.
Pipeline Information
The Company currently has three abbreviated new drug
applications, or ANDAs filed with the FDA, targeting products with
a market size of over $0.5 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 IQVIA data for the 12 months ended September 30, 2017. The
Company’s proprietary pipeline includes NDAs for Primatene® Mist
and intranasal naloxone. The Company is currently developing
several other proprietary products with various 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. 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.
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
litigation matters, collection of the bond posted by the Plaintiffs
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
Noted products are trademarks or registered trademarks of their
respective owners.
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