An even more dramatic example was the approval of Makena, a drug made by KV Pharmaceutical of St.

FORBES: Our Mixed Up Views On The Mixed Up Medicines Responsible For Deadly Meningitis

An international trial is ongoing to learn if there is also improvement in the outcome of babies born to women given Makena.

FORBES: New Drug To Prevent Pre-Term Birth Approved

Is it possible for KV Pharmaceutical to salvage its Makena franchise?

FORBES: KV Pharma Finally Wins A Victory, For Now

Patient advocates and the FDA had worked with KV to get Makena approved in the hopes that a safer, branded version would be better for moms and babies.

FORBES: Our Mixed Up Views On The Mixed Up Medicines Responsible For Deadly Meningitis

As KV Pharma followers may recall, Makena was originally projected to become a big moneymaker after the FDA approved the treatment early last year under the Orphan Drug Act.

FORBES: KV Pharma Finally Wins A Victory, For Now

The U.S. Food and Drug Administration today approved Makena (hydroxyprogesterone caproate) injection to reduce the risk of preterm delivery before 37 weeks of pregnancy, in pregnant women with a history of at least one spontaneous preterm birth.

FORBES: New Drug To Prevent Pre-Term Birth Approved

As a result, he granted a preliminary injunction to KV Pharma, because the drugmaker is likely to be able to demonstrate that Georgia Medicaid is violating the law by failing to cover Makena ( here is the ruling).

FORBES: KV Pharma Finally Wins A Victory, For Now

At the same time, KV Pharma filed a lawsuit against the FDA for failing to take action against compounders ( find it here), and also sued Georgia and South Carolina for restricting Makena coverage ( link to lawsuits are here).

FORBES: KV Pharma Finally Wins A Victory, For Now