Generics increase competition: study
The study by an MIT professor and Analysis Group researchers reportedly confirmed that the increase in generics had not reduced incentives to challenge brand name patents.
The agency denied Pain Therapeutics' and Durect's abuse-deterrent opioid in a complete response letter after warning the drugmakers about how they promoted the drug.
The OPDP sent its second untitled letter this week, this time to Durect and Pain Therapeutics over the presentation of Remoxy ER.
The regulator cited inconsistencies with how safety trial data was recorded in a report released ahead of the advisory committee's meeting on Wednesday.