FDA Makes Market Difficult For Drug Developers To Enter

Armen Hareyan's picture

Acute sinusitis market is increasingly difficult to penetrate due to increasing regulatory demands, stiff generic competition, and significant formulary hurdles.

According to the new report entitled Plethora of Generics and Heavy Hand of FDA Make This a Difficult Market to Enter: A Sinusitis (Acute) Study, an analysis of the leading therapies prescribed for acute sinusitis reveals that Johnson & Johnson's Levaquin offers a superior clinical profile even though it's reserved for later lines of therapy or more severe infections.


The FDA has been demanding increasingly stringent requirements for new drugs seeking approval for acute sinusitis. "Recent regulatory setbacks including Replidyne's faropenem and Oscient's gemifloxacin suggest that drug developers are facing greater regulatory scrutiny and demands for clinical efficacy and safety," said Danielle Drayton, Ph.D., analyst at Decision Resources. "So far, none of the drugs in development have shown better efficacy than currently available agents. Consequently, emerging therapies will find it difficult to gain FDA approval for the treatment of acute sinusitis."

Plethora of Generics and Heavy Hand of FDA Makes This a Difficult Market to Enter: A Sinusitis (Acute) Study covers the current and future state of the acute sinusitis drug market. The report includes the following:

- More than 3,000 physician responses that define drug attributes that drive prescription now and in the future.