KV, Makena And Preemies: Does FDA Approval Mean Monopoly?

Ok so here's the deal. A progesterone shot that aids in the prevention of premature births was priced at $10 to $20 per injection, but was made cheaply in special pharmacies that custom-compound treatments that were not federally approved, but effective. Now that KV Pharmaceutical has gained FDA approval for Makena, the price will go up to $1,500 a shot and as much as $30,000 throughout a pregnancy. Just approved by the FDA last month, KV's Makena is a commercial form of the low-cost progesterone treatments used by women for years. Considering the FDA has been on something of a crusade to sweep aside unapproved drugs. The medical community had supported KV's quest to win the FDA nod for Makena, but were not expecting a price increase of over $1,000 USD. Makena, commonly referred to as "17P," is the first and only FDA-approved treatment indicated to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth, which is a subset of the overall population of women at risk for preterm birth. According to the March of Dimes, preterm birth, or the birth of a baby at less than 37 completed weeks of pregnancy, affects one in eight babies born in the United States. Additionally, the rate of preterm birth has increased more than 35% in the last 25 years, and late preterm births, or babies born at 34 to 36 weeks of pregnancy, account for nearly three quarters of all preterm births in the United States. Via KV, Makena And Preemies: Does FDA Approval Mean Monopoly?