Mylan’s generic Sular gets FDA OK
PITTSBURGH — The Food and Drug Administration has approved a generic hypertension treatment made by Mylan.
Mylan announced the approval Friday of nisoldipine extended-release tablets in the 8.5-mg, 17-mg, 25.5-mg and 34-mg strengths. The drug is a generic version of Shionogi Pharma’s Sular, which had sales of about $103 million during the 12-month period ended in September 2010, according to IMS Health.
Mylan was the first company to file a regulatory approval application for the drug and is thus entitled to 180 days in which to compete directly with the branded version under the provisions of the Hatch-Waxman Act of 1984, the law that created a regulatory approval pathway for generic pharmaceutical drugs.
Italo Pennella named VP pharmacy at ECRM
NEW YORK — A former Albertsons executive has been named the newest VP pharmacy at ECRM.
Italo Pennella, a licensed pharmacist, will utilize his insight on the pharmaceutical supply chain as ECRM’s newest executive. At Albertsons, Pennella’s career spanned more than 10 years, which included oversight of all brand manufacturer relationships. Prior to joining ECRM, Pennella most recently served as associated director of trade for Otsuka and Schering-Plough/Organon.
“We are excited to have Pennella as part of our team and look forward to his support and insights to our rapidly growing pharmacy events. His diverse background will benefit him in his role to expand all areas of pharmacy at ECRM,” said Charlie Bowlus, ECRM CEO and founder.
Matrix obtains license agreement for HIV treatment
PITTSBURGH — A Mylan subsidiary has inked a nonexclusive license agreement with Tibotec Pharmaceuticals to manufacture, market and distribute a generic version of an HIV treatment.
Pending the regulatory approval of TMC278 (rilpivirine hydrochloride), Matrix Labs will have the right to manufacture once-daily 25-mg TMC278 as a single-agent medicine and a fixed-dose combination product, Mylan said. Matrix also will be able to market the drug in sub-Saharan Africa, certain developing countries and India.
Prior to the signing of license agreements, TMC278 was submitted for regulatory approval in the United States, Europe, Canada, Switzerland, Australia, Russia and South Korea. Upon approval, it is expected that TMC278, in combination with other antiretroviral medicinal products, will be indicated for the treatment of HIV-1 infection in treatment-naive adult patients.
"This agreement represents additional recognition for Mylan’s Matrix in the antiretroviral market, in which Matrix is a leader," Mylan president Heather Bresch said. "It also marks a significant step toward the future access of this important new product being developed by Tibotec Pharmaceuticals for patients living with HIV/AIDS. By obtaining this license at this time, we can now begin our research-and-development phase for our formulation to ensure that a generic version will be available in developing countries as quickly as possible. This was an important step in ensuring that novel ARV treatments available in more fortunate countries are accessible to patients in need all over the world."