The cost of Makena, a preterm labour preventative marketed in the US, is to rise from $10-20 to as much as $1,500 per dose, after manufacturer KV Pharmaceutical received market exclusivity.

The drug, a form of progesterone, has until now been manufactured cheaply by special pharmacies that custom-compound treatments that have not federally approved.

However, official approval from the US Food and drug Administration prompted KV Pharmaceutical to announce an almost 100-fold price increase based on the claim that they can now ensure consistently high quality.

The move could raise the cost of treatment to as much as $30,000.

The change to raise the costs so dramatically has been met with heavy criticism, with Massachusetts Medicaid deputy medical director Dr Roger Snow telling Associated Press, “That’s a huge increase for something that can’t be costing them that much to make. This is about making money.”

KV Pharmaceutical has announced a patient assistance programme in order to help low-income women access the drug at low or no cost.