FDA Approves New Drug Application For Amphastar’s Dextrose Injection

Amphastar Pharmaceuticals announced that the US Food and Drug Administration (FDA) has approved its Abbreviated New Drug Application (ANDA) for Dextrose injection 50% in the 50 ml Luer-Jet Prefilled Syringe System.

Amphastar (AMPH) has sold and marketed the injection under the “grandfather” exception to the FDA’s “Prescription Drug Wrap-Up” program over the last 40 years. Notably, the Dextrose injection generated net revenues of $7.6 million for the year ended Dec. 31, 2020.

Amphastar CEO Dr. Jack Zhang said, “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.”

Earlier this month, Amphastar reported 4Q results. The company’s 4Q adjusted earnings more than doubled on a year-over-year basis to $0.16 per share and outpaced Street estimates of $0.14. Revenues increased 15% to $95.9 million and exceeded analysts’ expectations of $88.94 million. (See Amphastar stock analysis on TipRanks)

On March 15, Needham analyst Serge Belanger maintained a Hold rating on the stock, as the analyst believes “AMPH’s valuation embeds the upside of near-term approvals.”

The rest of the Street is cautiously optimistic about the stock with a Moderate Buy consensus rating. That’s based on 2 analysts suggesting a Buy and 3 analysts recommending a Hold. The average analyst price target of $22.33 implies a 23.3% upside potential to current levels. Shares have increased 19.8% over the past year.

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