Latest From Akorn Inc.
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.
After receiving multiple Form 483s, Akorn receives yet another warning letter in the span of six months from the US Food and Drug Administration.
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.
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.
- Medical Devices
- Generic Drugs
- OTC, Consumer
- Radiopharmaceuticals, Contrast Agents
- Specialty Pharmaceuticals
- Therapeutic Areas
- North America
- 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
Phone: (800) 932-5676
1925 West Field Ct.
Lake Forest, IL 60045
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