Content about Orphan drug

MENLO PARK, Calif. — A drug maker is suing the Food and Drug Administration to force the agency to give a special designation to one of its drugs.

Depomed announced that it had filed suit against the FDA in federal district court for the District of Columbia seeking an order that would require the agency to grant the drug Gralise (gabapentin) orphan drug exclusivity for the management of post-herpetic neuralgia. The disease, also known as PHN, is a condition causing prolonged pain in people who have had shingles, a complication of chickenpox.

CAMBRIDGE, Mass. — The Food and Drug Administration has granted orphan drug designation to a chemotherapy drug made by Merrimack Pharmaceuticals for pancreatic cancer, the drug maker said Monday.

Merrimack announced that it received the designation for MM-398, described as a novel, stable, nanotherapeutic encapsulation of the chemotherapy drug irinotecan.

MOUNTAIN VIEW, Calif. — The Food and Drug Administration has granted orphan drug designation to an investigational treatment made by Edison Pharmaceuticals for rare diseases, Edison said Wednesday.

MADISON, Wis. — The Food and Drug Administration has granted orphan drug designation to a treatment made by Mithridion for a rare neurological disorder, Mithridion said Monday.

STOCKHOLM The Food and Drug Administration has given orphan drug designation to a treatment for a rare kidney disease under mid-stage clinical development by privately owned Swedish drug maker PharmaLink, the company said.

The FDA granted the designation to Nefecon (PL-56), a treatment for IgA nephropathy, also known as Berger’s disease, a disorder that leads to end-stage kidney disease. The FDA gives orphan drug designation to incentivize development of treatments for rare and serious disorders.