Mylan gets go-ahead for generic Effexor XR
PITTSBURGH — The Food and Drug Administration has approved a generic drug for depression and anxiety made by Mylan, the drug maker said Thursday.
Mylan announced the approval of venlafaxine hydrochloride extended-release capsules in the 37.5-mg, 75-mg and 150-mg strengths.
The drug, used to treat major depressive disorder and social anxiety disorder, is a generic version of Effexor XR, made by Wyeth. Mylan is launching the drug under a licensing agreement it made with Wyeth before its purchase by Pfizer.
Velafaxine hydrochloride extended-release capsules had sales of $2.3 billion during the 12 months ended in March, according to IMS Health.
Drug shortage bill enters Senate
NEW YORK — Legislation recently introduced in the Senate aims to address the issue of drug shortages.
The Preserving Access to Life-Saving Medications Act, introduced in February by Sen. Amy Klobuchar, D-Minn., would require drug manufacturers to inform the Food and Drug Administration when supplies of a drug may be running low, allowing the agency to inform hospitals and attempt to address shortages.
The bill currently has nine cosponsors and is under review by the Senate Committee on Health, Education, Labor and Pensions, according to congressional records.
BMS, Roche to study skin cancer drugs
NEW YORK — Bristol-Myers Squibb will collaborate with Roche to investigate the use of a combination of the companies’ drugs in patients with a deadly form of skin cancer.
The companies will conduct a phase 1/2 trial to test the safety and efficacy of BMS’ Yervoy (ipilimumab) in combination with Roche’s investigational drug vemurafenib in patients with melanoma that has spread to other parts of the body.
“Metastatic melanoma is one of the most aggressive forms of cancer,” BMS SVP development and medical affairs Brian Daniels said. “We are excited to be working with Roche to evaluate the potential that together; Yervoy and vemurafenib could improve outcomes for melanoma patients.”