Amphastar Pharmaceuticals Receives FDA Approval for Dextrose Injection

Rhea-AI Summary

Amphastar Pharmaceuticals (NASDAQ: AMPH) announced FDA approval for its Dextrose injection 50% in a 50 mL prefilled syringe. Previously marketed under the 'grandfather' clause, the product generated net revenues of $7.6 million in 2020. This approval allows Amphastar to address drug shortages, enhancing its manufacturing reputation. The company has several ANDAs and biosimilars in progress, targeting a cumulative market size of approximately $25 billion. CEO Dr. Jack Zhang emphasized the commitment to product quality and market needs.

Positive

• FDA approval for Dextrose injection 50% enhances market presence.
• Opportunity to address drug shortage issues with the approved product.
• Potential revenue growth from a market size of $25 billion across ANDAs and biosimilars.

Negative

• None.

RANCHO CUCAMONGA, Calif., March 29, 2021 (GLOBE NEWSWIRE) -- Amphastar Pharmaceuticals, Inc. (NASDAQ: AMPH) announced that the U.S. Food and Drug Administration (“FDA”) approved the Company’s Abbreviated New Drug Application (“ANDA”) for Dextrose injection 50% 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 Dextrose injection for the year ended December 31, 2020, were $7.6 million.

Amphastar’s CEO and President, Dr. Jack Zhang, commented: “The FDA’s approval of Dextrose, a product often on the Agency’s Drug Shortage list, offers an opportunity to ensure quality products are produced at the highest standard and highlights Amphastar’s manufacturing capabilities to fulfill such market needs.”

Pipeline Information

The Company currently has five ANDAs on file with the FDA targeting products with a market size of approximately $2.3 billion, three biosimilar products in development targeting products with a market size of approximately $13 billion, and seven generic products in development targeting products with a market size of approximately $10.5 billion. This market information is based on IQVIA data for the 12 months ended December 31, 2020. The Company is currently developing multiple proprietary products with injectable and intranasal dosage forms.

Amphastar’s Chinese subsidiary, ANP, currently has 14 Drug Master Files, or DMFs, on file with the FDA and is developing several additional DMFs.

Company Information

Amphastar is a bio-pharmaceutical company that focuses primarily on developing, manufacturing, marketing, and selling technically-challenging generic and proprietary injectable, inhalation, and intranasal 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 and resources are available at www.amphastar.com.

Amphastar’s logo and other trademarks or service marks of Amphastar, including, but not limited to Amphastar^®, Primatene Mist^®, Amphadase^®, and Cortrosyn^®, are the property of Amphastar.

Forward-Looking Statements

All statements in this press release and in the conference call referenced above 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, product development, the timing of FDA filings or approvals, including the DMFs of ANP, the timing of product launches, acquisitions and other matters related to its pipeline of product candidates, its share buyback program and other future events, such as the impact of the COVID-19 pandemic and related responses of business and governments to the pandemic on our operations and personnel, and on commercial activity and demand across our business operations and results of operations. 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, including in the Annual Report on Form 10-K for the year ended December 31, 2020, filed with the SEC on March 15, 2021. In particular, the extent of COVID-19’s impact on our business will depend on several factors, including the severity, duration and extent of the pandemic, as well as actions taken by governments, businesses, and consumers in response to the pandemic, all of which continue to evolve and remain uncertain at this time. 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. The forward-looking statements in this release speak only as of the date of the release. Amphastar undertakes no obligation to revise or update information or any forward-looking statements in this press release or the conference call referenced above to reflect events or circumstances in the future, even if new information becomes available or if subsequent events cause Amphastar’s expectations to change.

Contact Information:

Amphastar Pharmaceuticals, Inc.
Bill Peters
Chief Financial Officer
(909) 980-9484

FAQ

What did the FDA approve for Amphastar Pharmaceuticals on March 29, 2021?

The FDA approved Amphastar Pharmaceuticals' ANDA for Dextrose injection 50% in a 50 mL prefilled syringe.

What is the market potential of Amphastar’s Dextrose injection?

The Dextrose injection, previously marketed under FDA's grandfather clause, presents an opportunity to generate revenue, contributing to $7.6 million in revenue in 2020.

How many ANDAs does Amphastar currently have on file?

Amphastar has five ANDAs on file with the FDA targeting a combined market size of approximately $2.3 billion.

What are the future prospects for Amphastar Pharmaceuticals?

Future prospects include several products in development with a cumulative market size of approximately $25 billion, including ANDAs and biosimilars.

Who commented on the FDA approval, and what did they say?

CEO Dr. Jack Zhang highlighted the approval's significance in ensuring product quality and addressing market needs, especially related to drug shortages.