FDA Approves ONFI™ (clobazam)

FDA Approves ONFI™ (clobazam)

“As an epileptologist treating patients with a variety of challenging seizure disorders, I’m aware of the need for new add-on therapies to address the severe and frequent seizures associated with LGS,” said Joan A. Conry, MD, professor of neurology at Children’s National Medical Center in Washington, D.C., and a principal investigator of the CONTAIN Trial. “Clobazam, now approved as ONFI, was shown to be effective as adjunctive therapy for reducing seizures associated with LGS,1 and its upcoming availability provides hope for additional seizure management to patients and their physicians, caregivers and families.”

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US Drug Approval Process

US Drug Approval Process

How much time and money does it take to bring a drug to market in the United States?  According to FDA estimates, it takes an average of 8 ½ to 17 years, from drug conception to marketing, before a drug is finally FDA approved for use in the general patient population.  An article published in Health Affairs (1996) estimated the cost of brining a new drug to market as being between $500 and $2,000 million.  But before a drug (chemical) may undergo human testing towards drug approval, pre-clinical research must be conducted.  In...

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Orphan Drug Act of 1983

Orphan Drug Act of 1983

& Rare Diseases Approximately 5,000 rare diseases have been identified. 10-20 million Americans suffer from rare diseases, 50% of which are pediatric patients. A disease is considered rare or ‘orphan’ when the prevalence in the United States is less than 200,000. The diesease is termped ‘orphan’ because the pharmaceutical industry historically has not had an interest in developing treatments for these small patients populations. Drugs that have been FDA-aproved for use in these patients populations are termed orphan...

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