Amphastar Pharmaceuticals Receives FDA Approval for Enoxaparin Sodium Injection 300mg/3mL (100mg/mL) Multiple Dose Vial
March 19 2019 - 6:00AM
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 Enoxaparin Sodium
Injection 300mg/3mL (100mg/mL) Multiple Dose Vial (MDV). The
company currently manufactures and distributes Enoxaparin Sodium
Injection in prefilled syringe form and this approval of the
Multiple Dose Vial allows the company to begin offering the full
line of Enoxaparin products. Amphastar’s newly approved product was
determined by the FDA to be therapeutically equivalent to Lovenox®
(Enoxaparin Sodium Injection) MDV sold in the United States by
Sanofi-Aventis. Amphastar plans to launch Enoxaparin MDV in the
second quarter of 2019.
According to IQVIA, U.S market annual sales for the 12 months
ended December 31, 2018 for Enoxaparin Sodium Injection 300mg/3mL
(100mg/mL) MDV was approximately $11 million.
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 over $750 million, 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
December 31, 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,” “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. 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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