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Amphastar Pharmaceuticals Inc.

www.amphastar.com

Latest From Amphastar Pharmaceuticals Inc.

GSK’s Proposal For Mouth Spray Nicorette Delayed By FDA Questions On Label

Glaxo plans to make changes FDA requested in Complete Response letter sent on 18 October, the agency’s deadline for acting on NDA for an oral spray that delivers 1 mg per spray of aqueous buffered nicotine solution for oromucosal use.
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US Health Market In 2019: Unfinished Business Leaves Lasting Impression

Examples of unfinished business from 2019 include no legislation passed to reform OTC monograph program; FDA putting off until May the planned publication of an NPRM to allow firms to submit OTC NDAs with extra-label information to help guide consumers' self-selection; and no OTC naloxone for opioid overdose approved even after FDA's unprecedented step of developing model DFLs sponsors could use for their own label comprehension studies.

OTC Drugs Outlook 2019

Momenta Pays Out On Enoxaparin Shut-Out

Momenta Pharmaceuticals has agreed to pay $35.0m to settle claims that it manipulated generic approval processes in the US to shut competitor Amphastar out of the US enoxaparin market.

Legal Issues Private Payers

Keeping Track: Vertex’ Trikafta Speeds To US Approval; New Indications For AZ’s Farxiga, J&J’s Stelara, GSK’s Zejula

The latest drug development news and highlights from our US FDA Performance Trackers.

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Company Information

  • Industry
  • Pharmaceuticals
    • Drug Delivery
      • Nasal
      • Pulmonary
    • Generic Drugs
    • OTC, Consumer
  • Therapeutic Areas
  • Non-Specific
  • Alias(es)
  • Ownership
  • Public
  • Headquarters
  • Worldwide
    • North America
      • USA
  • Parent & Subsidiaries
  • Amphastar Pharmaceuticals Inc.
  • Senior Management
  • Jack Y Zhang, PhD, CEO, CSO
    Bill Peters, CFO, Treasurer
    Mary Z Luo, PhD, COO, Chief Scientist
    Jason B Shandell, JD, MBA, President
  • Contact Info
  • Amphastar Pharmaceuticals Inc.
    Phone: (800) 423-4136
    11570 6th St.
    Rancho Cucamonga, CA 91730
    USA
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