Amphastar Pharmaceuticals Receives FDA Approval for Sodium Bicarbonate Injection
September 20 2017 - 4:22PM
Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH) announced that on
September 19, 2017, the U.S. Food and Drug Administration (“FDA”)
granted approval of the company’s abbreviated new drug application
(“ANDA”) for Sodium Bicarbonate injection 8.4% in the 50 mL
Luer-Jet® Prefilled Syringe System. For the past 40 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 sodium bicarbonate injection for the
year ended December 31, 2016 were $5.9 million.
The company continues to market five grandfathered products,
(now termed “unapproved”) and has ANDAs pending approval for three
of these products. For the year ended December 31, 2016, the
company recorded net revenues of $27.6 million from these
unapproved products.
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 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
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 Peters
Chief Financial Officer
(909) 980-9484
Amphastar Pharmaceuticals (NASDAQ:AMPH)
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