This past year close to 100 new drugs were FDA-approved, so it’s encouraging to look back and see the progress that’s been made as 2015 ends. In fact, more than 40 novel drugs, including a new drug class for patients with high cholesterol, a first-time biosimilar, a life-saving heart failure drug, and a controversial agent to boost women’s libido, all successfully passed through the Agency’s halls.
With so many new approvals, it’s next to impossible to pick out those that are truly “tops.” What may be a top drug for one person — for example, an agent to extend survival from metastatic melanoma (Imlygic) — may not be a top drug to another patient who suffers with plaque psoriasis (Cosentyx). How can a new treatment that more easily reverses an opioid overdose (Narcan Nasal Spray) be “better” than an approval for advanced breast cancer (Ibrance). The bottom line is – they aren’t. But with so many varied and cutting-edge approvals this year, we had to pick a few.
One fact is consistent: the FDA has been increasing its NDA approval rate and regulatory efficiency year-after-year, with approvals ranging from orphan drugs to mega-blockbusters growing in numbers annually. Below are just a few of the “top” – and sometimes controversial – new drug approvals from 2015. If you need to access all of the FDA drug approvals and new indications from 2015, you can easily access them from Drugs.com.