FDA approves generic hypertension pill made by Actavis
DUBLIN — The Food and Drug Administration has approved a generic drug for high blood pressure made by Actavis, the company said Friday.
Actavis announced the approval of telmisartan immediate-release tablets in the 20-mg, 40-mg and 80-mg strengths, which it intends to release immediately.
The drug is a generic version of Boehringer Ingelheim’s Micardis, which had sales of about $274 million during the 12-month period that ended in September, according to IMS Health. As the first company to successfully apply for approval of a generic version, Actavis has 180 days in which to compete exclusively against Boehringer Ingelheim’s product, according to FDA regulations.
FDA approves combination of two GSK drugs for skin cancer
SILVER SPRING, Md. — The Food and Drug Administration has approved two drugs made by GlaxoSmithKline for use together in patients with advanced melanoma that can’t be removed by surgery or has spread to other parts of the body, the agency said Friday.
The FDA announced the new approval for Mekinist (trametinib) and Tafinlar (dabrafenib). The agency originally approved the two drugs for use as single agents for the same indication in May 2013.
According to the National Cancer Institute, part of the National Institutes of Health, an estimated 76,690 Americans were diagnosed last year with melanoma, the most aggressive type of skin cancer, and 9,480 died.
PDX executive Cheryl Jorgenson receives Certified Specialty Pharmacist endorsement
FORT WORTH, Texas — The clinical development director of Rx.com Pharmacy Benefit Coalition is among the first few dozen pharmacists to receive a specialty pharmacy certification, the company said.
Rx.com PBC, an affiliate of pharmacy technology company PDX, said Cheryl Jorgenson received her certified specialty pharmacist endorsement from the Specialty Pharmacy Certification Board, which is designed to indicate to employers, manufacturers, payers, providers and others that a pharmacist is an expert in specialty drugs. The SPCB administered the first exam in October, and Jorgenson is one of only 50 pharmacists in the country to receive the CSP certification.
The certification allows Jorgenson to advise Rx.com Pharmacy Benefit Coalition patients as to plan design and coverage issues regarding the entire range of drug treatments.
"Earning this recognition will assure our patients, customers, colleagues and clients that Cheryl is an expert not only in clinical specialty therapies, but also in all aspects of handling and delivery of specialty pharmaceuticals," Rx.com VP strategic planning Jerry Ray said. "By achieving the skills and recognition of Certified Speciatly Pharmacist, Cheryl demonstrates both a commitment to the profession and a level of knowledge for all aspects of specialty pharmacy including the dispensing, clinical management and patient outcomes."