FDA approves UCB’s Cimzia for psoriatic arthritis
BRUSSELS — The Food and Drug Administration has approved a new usage for a drug made by UCB, the drug maker said Monday.
UCB announced the approval of Cimzia (certolizumab pegol) for psoriatic arthritis in adults. Psoriatic arthritis is an inflammatory, autoimmune condition that causes pain, swelling and stiffness around the joints, usually combined with the skin lesions of psoriasis. The drug was already approved to treat rheumatoid arthritis and Crohn’s disease.
"The FDA’s approval of Cimzia for the treatment of active PsA provides an additional, effective treatment option for those living with the condition," director of rheumatology research at the Seattle-based Swedish Medical Center and University of Washington medicine professor Philip Mease said.
Amneal buys four generic drugs from Actavis
BRIDGEWATER, N.J. — Amneal Pharmaceuticals has bought rights to four generic drugs from Actavis, Amneal said Monday.
The generic drug maker announced the purchase of four drugs, two of which are currently marketed, one of which is awaiting Food and Drug Administration approval, and another of which is approved, but not marketed. The respective drugs are the contraceptive Zenchent Fe (norethindrone acetate; ethinyl estradion), a generic version of Femcon Fe; another generic norethindrone acetate and ethinyl estradiol product that is a generic version of Lo Loestrin Fe; the osteoporosis drug risendronate sodium, a generic version of Atelvia; and a third norethindrone acetate and ethinyl estradiol product that is a generic version of Loestrin 24 Fe.
Amneal’s acquisition of the drugs is dependent on the closing of Actavis’ purchase of Warner Chilcott. Financial terms of the Amneal-Actavis deal were not disclosed.
HDMA supports national pharmaceutical traceability legislation
ARLINGTON, Va. — The Healthcare Distribution Management Association on Saturday added its voice supporting national pharmaceutical traceability legislation (Drug Quality and Security Act/H.R. 3204).
“Now that the House of Representatives has passed legislation to strengthen the security of the pharmaceutical supply chain, only the Senate’s imminent vote stands in the way of establishing a federal uniform traceability framework for prescription medicines," stated John Gray, HDMA president and CEO. "For nearly a decade, HDMA has worked to replace the 50-state patchwork of rules and regulations with a federal solution that ensures regulatory clarity and consistency, helps prevent counterfeits, discourages gray market activities and enhances the safety and security of the pharmaceutical supply chain for all Americans."
"This is the right approach to further strengthen our pharmaceutical supply chain, help ensure safe, efficient delivery of medicines and protect patients from threats associated with counterfeit and diverted products," the association added in a letter to several Congressional leaders, coupling its voice with a host of industry associations supporting the legislation.
"In the absence of a national solution, the complexities of the current 50-state patchwork present a significant challenge to all supply chain partners and threaten to create weak links in the supply chain that will jeopardize patient safety," the association concluded.