New Indications

New indications are new uses for an existing drug or device that have been approved by the FDA. This can be a significant event for a company, as it can open up new markets and increase sales.

There are a few different ways that a new indication can be approved. One way is through the traditional drug approval process. This process can take many years and can be very expensive. Another way is through the accelerated approval process. This process is designed for drugs that treat serious or life-threatening diseases. It can take less time than the traditional process, but it requires more data to support the approval.

Once a new indication has been approved, the company can start marketing the drug or device for that use. This can be a very effective way to increase sales. For example, in 2015, the FDA approved a new indication for the drug Keytruda. This drug is used to treat cancer, and the new indication was for patients with advanced melanoma. Keytruda had already been approved for other types of cancer, but the new indication gave the company a much larger market for the drug.

New indications can be a very important part of a company's growth strategy. They can help to increase sales, improve the company's financial performance, and attract new investors.