Mylan launches generic version of Abbott’s Teveten
PITTSBURGH — Mylan has launched a generic drug for treating high blood pressure, the company said.
The drug maker announced the launch of eprosartan mesylate tablets in the 400-mg and 600-mg strengths. The drug is a generic version of Abbott’s Teveten and is used to treat hypertension.
Mylan was the first company to file a regulatory approval application with the Food and Drug Administration for the drug, thus entitling it to 180 days of market exclusivity in which to compete directly with Abbott. After that period, any company that wins approval from the FDA will be able to market a generic version of Teveten.
Teveten had sales of $4.9 million during the 12-month period ended in September, according to IMS Health.
FDA panel to review resubmitted NDA for pixantrone
SEATTLE — The Food and Drug Administration’s Oncologic Drugs Advisory Committee will review a resubmitted new drug application for a cancer treatment made by Cell Therapeutics.
The company said that the panel will review the NDA for pixantrone, which is designed to treat relapsed or refractory aggressive non-Hodgkin’s lymphoma in patients who failed two or more lines of prior therapy.
"We are pleased the FDA Office of Oncology Drug Products chose to bring our pixantrone NDA back to ODAC for review now that we have provided additional information and data recommended by the Office of New Drugs that we believe addresses the issues raised in the OODP complete response letter of April 2010," Cell Therapeutics CEO James Bianco said. "We believe the NDA demonstrates that pixantrone has a favorable benefit risk profile compared to standard chemotherapy in patients with relapsed or refractory aggressive NHL, a patient population for which there are no approved agents."
Cell Therapeutics noted that while the FDA will consider the recommendation of the panel, the final decision regarding the approval of the product is made by the agency itself.
FDA approves Prevnar 13 in older adults
NEW YORK — The Food and Drug Administration has approved a Pfizer vaccine for Streptococcus pneumoniae in adults ages 50 years and older, the company said.
Pfizer announced the FDA approval of Prevnar 13 (pneumococcal 13-valent conjugate vaccine [diphtheria CRM197 protein]) as a single-dose for adults.
"Pneumococcal disease, including pneumonia, in adults 50 years and older represents a significant personal and social health burden in the United States," Pfizer chairman and CEO Ian Read said. "The FDA approval of Prevnar 13 for these adults offers the potential to contribute to the health of millions of aging Americans."