how new indications work
new indications are an early sign that a particular drug or procedure may be worth investing in further for example a company that has already obtained regulatory approval for a particular drug would report new indications if their research suggests that additional applications for that drug might be possible new indications are therefore viewed as a positive development by most investors because they could signify additional revenue generating opportunities for a company s existing drugs in the united states companies must go through a rigorous and lengthy process in order to bring new drugs to the market the food and drug administration fda oversees the development and approval of new drugs through their new drug application nda process the process routinely takes years to complete with some stretching over a decade despite this lengthy process only about 30 of new applicants have their ndas approved 1although repurposing an existing drug can lead to reduced research and development r d costs there are nevertheless major costs involved in obtaining final fda approval for such repurposed drugs nevertheless because these drugs have already passed through the fda s nda process many companies view them as a less risky investment as compared to developing new drugs from scratch for these reasons one of the most efficient ways for pharmaceutical companies to expand into new markets would be to find new or expanded applications for products that have already received fda approval in fact some companies specialize in repurposing already approved drugs in an effort to reach the commercialization of new medicines more quickly real world example of a new indicationnew indications often appear in news releases for medical treatments and pharmaceutical companies when referring to drugs or equipment involved for example on aug 16 2018 the fda released a new indication approval for the drug opdivo nivolumab which treats cancers such as advanced melanoma advanced renal cell carcinoma and advanced squamous cell carcinoma of the head and neck 23