Dr. Reddy’s receives FDA approval for generic GERD treatment
HYDERABAD, India — Indian drug maker Dr. Reddy’s Labs has launched a generic treatment for gastroesophageal reflux disease.
The company announced Thursday the launch of pantoprazole sodium delayed-release tablets in the 20-mg and 40-mg strengths. The drug is a version of Protonix, made by Wyeth, now part of Pfizer.
Pantoprazole sodium delayed-release tablets had sales of around $1.8 billion during the 12-month period ended in September 2010, according to IMS Health.
Callen-Lorde Community Health Center opens pharmacy
NEW YORK — A nonprofit clinic that caters to New York’s gay, lesbian, bisexual and transgender communities and people living with HIV and AIDS has opened a new pharmacy.
Callen-Lorde Community Health Center announced the opening of the pharmacy at its main clinic in Manhattan’s Chelsea district, having received start-up funding support from the New York State Health Foundation and the federal Health Resources and Services Administration. The pharmacy will offer 90-day supplies of maintenance medications, online and telephone ordering of refills and discounts to uninsured patients with incomes less than 200% of the federal poverty level, who will be eligible for further discounts. Of the 14,000 patients the center saw last year, around half did not have health insurance, said executive director Wendy Stark.
“Opening our own pharmacy is the next step in our continuing mission to provide quality, affordable health care to the community,” Stark said. “The integration of on-site pharmacy access clinically enhances our comprehensive primary care services [and] offers a more convenient and less expensive option for our patients when filling their prescriptions.”
The center will have a ribbon-cutting ceremony on Jan. 28, attended by several New York state and city politicians.
Vertex’s hepatitis C drug granted priority review by FDA, Health Canada
CAMBRIDGE, Mass. — The Food and Drug Administration and Health Canada have granted priority review to a drug for treating hepatitis C.
Vertex Pharmaceuticals announced Thursday that the two agencies had given the designation to telaprevir for treating patients with chronic infections.
The FDA grants priority review to medicines that it determines to offer major advances in treatment or provide a treatment where no adequate therapy exists; standard review time is 10 months, but priority review reduces it to six, meaning the agency plans to finish its review by May 23. In Canada, standard review time is 18 months, and priority review reduces it to between six and nine.
“Data from phase-3 studies showed that when compared to currently available medicines, telaprevir-based combination therapy nearly doubled viral cure rates and cut treatment time in half for the majority of patients new to treatment,” said Peter Mueller, Vertex chief scientific officer and EVP global research and development. “We look forward to working with the FDA and Health Canada to make telaprevir available as quickly as possible for people with hepatitis C.”