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Akorn Inc.

www.akorn.com

Latest From Akorn Inc.

FDA Warning Letter Hits Akorn’s Subpar Root Cause Investigations

Akorn has been hit with its second warning letter this year, this time for similar issues at a different site, where the US FDA found the firm failed to adequately address problems with impurities and bottle defects. The Akorn letter may also be symptomatic of a larger problem being seen by the agency in the growing number of faulty root cause investigations.  


Manufacturing Quality

Akorn Receives Second Warning Letter In Six Months

After receiving multiple Form 483s, Akorn receives yet another warning letter in the span of six months from the US Food and Drug Administration. 

Manufacturing Compliance

Top US Court Is Asked To Review Inter Partes Reviews

Standards for determining obviousness via inter partes patent reviews, as well as procedures for affirming such determinations on appeal, must be reviewed by the US Supreme Court, two originators argue in their dispute with Akorn over Durezol difluprednate eye drops.

 


Intellectual Property Legal Issues

Akorn Reports ‘Sustained’ Progress On FDA Issues

Beleaguered niche generic drugmaker Akorn has reported stronger-than-expected first-quarter earnings and says it is making progress on resolving FDA-related compliance problems.

Sales & Earnings Strategy
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Company Information

  • Industry
  • Medical Devices
  • Pharmaceuticals
    • Generic Drugs
    • OTC, Consumer
    • Radiopharmaceuticals, Contrast Agents
    • Specialty Pharmaceuticals
  • Therapeutic Areas
  • Non-Specific
  • Alias(es)
  • Ownership
  • Public
  • Headquarters
  • Worldwide
    • North America
      • USA
  • Parent & Subsidiaries
  • Akorn Inc.
  • Senior Management
  • Raj Rai, CEO
    Duane A Portwood, CFO
    Jonathan Kafer, EVP, Sales & Mktg.
    Bruce Kutinsky, PharmD, COO
    Steve Lichter, EVP, Pharma Ops
    Randall E Pollard, Chief Accounting Officer
  • Contact Info
  • Akorn Inc.
    Phone: (800) 932-5676
    1925 West Field Ct.
    Ste. 300
    Lake Forest, IL 60045
    USA
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