Content about Depomed

October 17, 2012

FDA accepts regulatory filing for Depomed drug

The Food and Drug Administration has accepted a regulatory approval application for a drug for hot flashes from Depomed, the drug maker said.

MENLO PARK, Calif. — The Food and Drug Administration has accepted a regulatory approval application for a drug for hot flashes from Depomed, the drug maker said.

Depomed submitted its application to the FDA for Serada (gabapentin), an extended-release drug for hot flashes in menopausal women.

September 26, 2012

Depomed sues FDA over drug for shingles-related pain

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

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.