Category: US Drug Approval

FDA Approves ONFI™ (clobazam)

FDA Approves ONFI™ (clobazam) for the Adjunctive Treatment of Seizures Associated with Lennox-Gastaut Syndrome in Patients Two Years and Older Approval based on largest clinical trial to date evaluating pediatric and adult patients with a current or prior diagnosis of LGS1,2 DEERFIELD, Ill.–(BUSINESS WIRE)–Lundbeck Inc. (“Lundbeck”), a wholly owned subsidiary of H. Lundbeck A/S in […]

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 […]

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 […]