Makena receives FDA approval
SILVER SPRING, Md. — The Food and Drug Administration has approved a drug for preventing preterm births.
The agency announced Friday the approval of Baxter Pharmaceutical Solutions’ Makena (hydroxyprogesterone caproate) injection, for reducing the risk of preterm delivery before 37 weeks of pregnancy in pregnant women with a history of at least one spontaneous preterm birth.
Makena will be manufactured by Baxter for KV Pharmaceutical/Ther-Rx. Ther-Rx, which will market the drug, said it will be available in March. Makena is a specialty injectable and will be available through a network of specialty pharmacies and distributors that specialize in distributing specialty injectables and will be express mailed directly from the pharmacy/distributor to the healthcare provider or to the patient, depending on the preferred location for administration of weekly injections.
“Preterm birth is a significant public health issue in the United States,” FDA Office of New Drugs deputy director Sandra Kweder said. “This is the first drug approved by the FDA that is indicated to specifically reduce this risk.”
Lilly chief calls on industry, public policy to support innovation
LONDON — Public policies to support medical innovation will help drug companies address diseases that devastate people’s lives, a drug company executive said at a summit Thursday.
Speaking at The Economist magazine’s 2011 Pharma Summit, Eli Lilly chairman, president and CEO John Lechleiter called for a new approach to research in such illnesses as Alzheimer’s disease, diabetes and cancer. This included changing the way companies conduct research and public policies that promote an environment in which innovation can flourish.
“Our industry is taking too long,” Lechleiter said in his remarks. “We’re spending too much, and we’re producing far too little.”
Actavis OKed to market generic Protonix
MORRISTOWN, N.J. — Actavis has received approval from the Food and Drug Administration to market a generic version of a popular gastroesophageal reflux disease treatment.
The generic drug maker said it would market pantoprazole sodium delayed-release tablets in the 20-mg and 40-mg strengths. The drug is the generic equivalent of Pfizer’s Protonix, which had U.S. sales of approximately $1.6 billion for the 12 months ended Dec. 31, 2010, according to IMS Health.
Actavis said it would distribute the drug soon.