FDA OKs first generic under new approval pathway
The FDA used a new pathway aimed at speeding review for generics of products without competition for the first time by approving Apotex’s oral solution of potassium chloride for patients with low potassium levels.
The “Competitive Generic Therapy” designation was created in 2017 and grants approved applicants 180 days of market exclusivity, but their products must be commercially marketed within 75 days or the exclusivity will be forfeit.
Commissioner Scott Gottlieb has pushed to accelerate market entry of generics and biosimilars as a way to boost competition and lower prices.
