Latest From Akorn Inc.
Standards of evidence for obviousness used in US inter partes patent reviews will not be reviewed by the US Supreme Court. Nor will the court consider whether the Federal Circuit can confirm inter partes decisions without issuing an opinion.
Justices question why it took 170 years for the patent office to seek attorneys' fees from patent applicants who challenge its decisions in district court; USPTO acknowledges the delay is 'atmospherically unhelpful.'
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.
- 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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