MENLO PARK, Calif. (AP) — Depomed Inc. said Tuesday Pfizer Inc. has not yet filed a lawsuit over attempts to make an extended-release version of Pfizer Inc.’s Neurontin.
Neurontin was approved by U.S. regulators a decade ago for treating seizures and later for pain caused by shingles. Depomed has asked for Food and Drug Administration approval for its extended-release version called DM-1796, aimed at treating post-herpetic neuralgia, or nerve pain following shingles.
Neurontin’s generic name is gabapentin.
Depomed released the statement following expiration of a 45-day period open for Pfizer to file a lawsuit. If it had filed a lawsuit, it would have initiated a 30-month stay on the FDA’s ability to approve DM-1796.
“We look forward to a potential approval of DM-1796 in the first quarter of next year,” said Depomed President and CEO Carl A. Pelzel, in a statement.