This section highlights FDA-related milestones and regulatory updates for drugs developed by Amphastar Pharmaceuticals (AMPH).
Over the past two years, Amphastar Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
AMP-008 and Venofer. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
AMP-008 FDA Regulatory Events
AMP-008 is a drug developed by Amphastar Pharmaceuticals for the following indication: for the treatment or prevention of bronchospasm in patients four years of age and older.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- AMP-008
- Announced Date:
- May 22, 2024
- Indication:
- for the treatment or prevention of bronchospasm in patients four years of age and older
Announcement
Amphastar Pharmaceuticals, Inc announced that the U.S. Food and Drug Administration ("FDA") has granted approval for the Company's Abbreviated New Drug Application ("ANDA") for Albuterol Sulfate Inhalation Aerosol, previously known as AMP-008.
AI Summary
Amphastar Pharmaceuticals announced that the FDA has approved its Abbreviated New Drug Application (ANDA) for Albuterol Sulfate Inhalation Aerosol, formerly known as AMP-008. This generic inhalation aerosol is intended for the treatment or prevention of bronchospasm and for preventing exercise-induced bronchospasm in patients aged four years and older. The FDA confirmed that Amphastar’s product is both bioequivalent and therapeutically equivalent to Teva Respiratory LLC’s ProAir® HFA. Amphastar’s CEO, Dr. Jack Zhang, emphasized that the approval reflects the company’s strong technological and manufacturing capabilities, and he underscored the benefit to patients through increased access to a high-quality, U.S.-manufactured product. This approval marks an important step forward for Amphastar as it plans to expand its portfolio of generic inhalation products in the future.
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Venofer FDA Regulatory Events
Venofer is a drug developed by Amphastar Pharmaceuticals for the following indication: In patients with chronic kidney disease (CKD).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Venofer
- Announced Date:
- August 11, 2025
- Indication:
- In patients with chronic kidney disease (CKD).
Announcement
Amphastar Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration ("FDA") has approved the Company's Abbreviated New Drug Application ("ANDA") for Iron Sucrose Injection, USP 50mg/2.5mL, 100mg/5mL, and 200mg/10mL in single-dose vials, previously referred to as AMP-002.
AI Summary
Amphastar Pharmaceuticals announced that the U.S. Food and Drug Administration has approved its Abbreviated New Drug Application for Iron Sucrose Injection, USP in single‐dose vials of 50 mg/2.5 mL, 100 mg/5 mL, and 200 mg/10 mL. The FDA found the generic product bioequivalent and therapeutically equivalent to Venofer® for treating iron deficiency anemia in chronic kidney disease patients.
Dr. Jack Zhang, Amphastar’s President and CEO, said the approval highlights the company’s expertise in complex generics and in‐house manufacturing. Amphastar plans to launch the iron sucrose injection in the third quarter of 2025. According to IQVIA, U.S. sales of Venofer® were about $513 million for the year ending June 30, 2025. Amphastar’s broader pipeline includes multiple ANDAs, a biosimilar insulin candidate, and other biosimilar and generic products targeting markets worth billions.
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