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Amphastar Pharmaceuticals, Inc.

http://www.amphastar.com

Latest From Amphastar Pharmaceuticals, Inc.

Amphastar’s Forteo ANDA Hit With CRL As Wait Goes On

Amphastar will not be receiving approval in 2022 for its proposed generic version of Eli Lilly’s Forteo (teriparatide) peptide for the treatment of osteoporosis, after the FDA told the company it could not issue an approval at this stage.

Complete Response Letters Generic Drugs

Amphastar Receives FDA Approval For Regadenoson Following Solid Q1

Amphastar has become the fifth firm to receive FDA approval for generic regadenoson, but the exact launch date for the firm and its other generic competitors remains uncertain.

Sales & Earnings Launches

Amphastar Eyes Sun Pharma Showdown With US Ganirelix Approval

Amphastar is celebrating what it says is its fourth injectable peptide product approval from the USFDA with its generic version of Organon’s ganirelix acetate, in the process setting up a rivalry with Sun Pharma and commercial partner Ferring Pharmaceuticals.

Approvals FDA

US Needs OTC Inhalers For Asthma Treatment, And FDA Should Force A Switch, Researchers Say

In addition to epinephrine inhaler indicated for emergency use FDA currently allows for nonprescription access, a “positive step forward would be to make inhaled albuterol available OTC,” say researchers in a recent JAMA article.

Prescription To OTC Switch Drug Approval Standards
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Company Information

  • Industry
  • Pharmaceuticals
  • Pharmaceuticals
    • Drug Delivery
    • Generic Drugs
    • OTC, Consumer
    • Specialty Pharmaceuticals
    • Drug Delivery
      • Nasal
      • Pulmonary
  • Other Names / Subsidiaries
    • Amphastar France Pharmaceuticals (AFP)
    • Armstrong Pharmaceuticals, Inc.
    • International Medication Systems (IMS)
    • Nanjing Puyan Pharmaceutical Technology (ANP)
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