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Charleston Laboratories, Inc.

http://charlestonlabs.com/

Latest From Charleston Laboratories, Inc.

PDUFA VII Could Increase Transparency Of REMS Release Process

Proposed commitment letter language included a look at eliminating REMS, potentially to more clearly outline the process.

User Fees Risk Management

Closing The Books On Purdue – And US FDA’s Policies To Control Opioids

A massive settlement of opioid litigation is intended to end the era of opioid marketing defined by OxyContin. It also like closes the books on efforts to rely on the US FDA to control the prescription abuse crisis.

Discomfort With REMS Highlighted At Negative Hydexor Advisory Committee

US FDA advisory committee votes down Charleston’s emesis-reducing opioid once again, citing a poorly worded indication and REMS, along with a general lack of confidence that risk management plans can be successful in the real world.

Advisory Committees Drug Safety

US FDA’s Help May Get Charleston’s Hydexor Through Second Advisory Committee

After appealing FDA’s rejection, Charleston narrowly tailored the proposed indication for its emesis-reducing opioid to an in-patient population and crafted its own REMS to try and address advisors past safety concerns. Briefing documents indicate the FDA might have been learning towards approving the drug on the earlier review cycle, but the initial advisory committee vote shifted the agency’s thinking.

Advisory Committees Drug Safety
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Company Information

  • Industry
  • Pharmaceuticals
  • Pharmaceuticals
    • Specialty Pharmaceuticals
  • Other Names / Subsidiaries
    • LOCL Pharma, Inc.
    • Olas Pharma, Inc.
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