FDA accepts NDA filing for Impax’s Parkinson’s disease treatment
HAYWARD, Calif. — The Food and Drug Administration has accepted a new drug application for the treatment of idiopathic Parkinson’s disease.
Impax Pharmaceuticals, the branded products division of Impax Labs, said it filed its NDA for the investigational drug IPX066, an extended-release capsule formulation of carbidopa-levodopa, for review in December 2011. IPX066 has been licensed to GlaxoSmithKline for countries outside the United States and Taiwan for development and marketing.
The Prescription Drug User Fee Date for a decision by the FDA is Oct. 21, Impax said.
FDA approves Korlym for Cushing’s syndrome
SILVER SPRING, Md. — The Food and Drug Administration has approved a drug for a rare disorder that previously had no approved medical therapies, the agency said.
The FDA announced the approval of Menlo Park, Calif.-based Corcept Therapeutics’ Korlym (mifepristone) for endogenous Cushing’s syndrome, a disorder that results from overproduction of cortisol, a steroid hormone that increases blood-sugar levels.
The drug is approve for patients with the disease who have Type 2 diabetes or glucose intolerance and are not candidates for surgery or who have not responded to surgery, and the agency said about 5,000 patients will be eligible for treatment.
FDA committee recommends approval for obesity drug
MOUNTAIN VIEW, Calif. — A panel of experts at the Food and Drug Administration has recommended approval for an obesity drug that so far had not met much success at the agency.
Vivus announced Wednesday that the FDA Endocrinologic and Metabolic Drugs Advisory Committee voted 20-2 in favor of approving Qnexa (phentermine and topiramate) for obesity in adults. The FDA is not bound by advisory committee votes when it decides whether or not to approve a drug, but usually follows them.
"We are pleased with the panel’s approval recommendation in support of the safety and efficacy of Qnexa," Vivus president Peter Tam said. "We look forward to working with the FDA as they complete their evaluation."
The FDA originally accepted Vivus’ regulatory application for Qnexa in February 2010, but the Endocrinologic and Metabolic Drugs Advisory Committee voted 10-6 against recommending approval in July of that year, citing concerns over the safety of the drug. In October 2010, the FDA issued a complete response letter, a notice that it had declined to approve the drug, and requested additional clinical study data.