FDA to review experimental opioid drug
BEDMINSTER, N.J. — The Food and Drug Administration will decide in late August whether to approve an experimental opioid painkiller made by QRxPharma, the drug maker said Thursday.
Australia-based QRxPharma is seeking approval for Moxduo (morphine and oxycodone), and the FDA plans to decide whether to approve the drug on Aug. 26.
"We are pleased that the FDA has formally accepted our resubmitted Moxduo [new drug application]," QRxPharma CEO and managing director John Holaday said. "We expect the advisory committee meeting to be scheduled between late June and late July and will update shareholders once formal notification has been received."
FDA approves Par generic obsessive compulsive disorder drug
WOODCLIFF LAKE, N.J. — The Food and Drug Administration has approved a drug for obsessive compulsive disorder made by Par Pharmaceutical Cos., the drug maker said Thursday.
Par announced the approval and shipment of fluvoxamine maleate extended-release capsules in the 100-mg and 150-mg strengths. The drug is a generic version of Jazz Pharmaceuticals’ Luvox CR.
Par said it was the first company to file a complete regulatory approval application for a generic version of the drug, thus entitling it to 180 days of market exclusivity in which to compete directly with the branded drug. Luvox CR has annual sales of about $51 million, according to IMS Health.
Increasing use of generics would save money amid sequester, GPhA tells members of Congress
WASHINGTON — Amid a tide of automatic spending cuts resulting from the failure of Congress and the White House to agree on a budget, the generic drug lobby has offered some suggestions to generate savings.
The Generic Pharmaceutical Association, an industry trade group, sent letters to members of the House and Senate outlining six ways to increase use of generic drugs, which it said would save money: Encourage generic drug use for the Medicare Low Income Subsidy population; close loopholes in the current REMS strategy; pass policy prohibition against state-level carve-out laws that restrict use of certain generics; integrate incentives for generic use and adherence in chronic management reforms; restrict the exclusivity for biotech drugs from 12 years to seven; and increase Medicaid payments to states that increase the use of the least costly drugs available.
"So many ways to cut costs require enormous sacrifice," GPhA president and CEO Ralph Neas said. "But generics have proven that drug-cost reductions are available while maintaining safety, efficacy and improved health outcomes. We can offer patients quality, FDA-approved medicines at a fraction of the price and save billions in the process."