FDA extends review of lung cancer treatment
SOUTH SAN FRANCISCO, Calif. The Food and Drug Administration has extended its review period for a lung cancer drug made by Genentech and OSI Pharmaceuticals, the two companies announced.
OSI submitted additional study data to support the companies’ regulatory approval application for Tarceva (erlotinib) as a first-line maintenance therapy for advanced non-small cell lung cancer, prompting the FDA to extend its review period by 90 days. The agency would have decided on whether to approve the drug on Monday, but will take until April.
Tarceva already has approval as a monotherapy in patients with locally advanced or metastatic non-small cell lung cancer whose disease has progressed after up to two courses of chemotherapy and as a treatment for pancreatic cancer, in combination with gemcitabine chemotherapy.
Schnucks Pharmacies offering free prenatal vitamins to expectant mothers
ST. LOUIS January is National Birth Defects Prevention Month, and a Midwestern supermarket pharmacy chain is giving expectant mothers free prenatal vitamins to mark the occasion.
Schnucks Pharmacies, part of the Schnuck Markets company, will begin offering free prescription prenatal vitamins to pregnant women at its 103 stores under its Health and Wellness Program beginning Monday, Schnucks announced.
“It’s a major investment for our company, but we feel a responsibility to help where we can,” Schnucks VP pharmacy Michael Juergensmeyer said in a statement. “Due to economic considerations, many patients don’t refill prescriptions for chronic conditions, let alone take prescription prenatal vitamins for wellness care. We share doctors’ concerns and recognize the need to make good prenatal care more affordable for all.”
FDA commissioner Hamburg salutes healthcare professionals for H1N1 efforts
SILVER SPRING, Md. Healthcare professionals got a big “thank you” from the head of the Food and Drug Administration.
FDA commissioner Margaret Hamburg sent a letter to healthcare professionals thanking them for their efforts during the 2009 H1N1 influenza outbreak.
“In November, I wrote to thank you for your efforts during the 2009 H1N1 influenza outbreak and to provide information about the development and FDA approval of the H1N1 vaccines,” Hamburg wrote. “I mentioned our continuing robust efforts to monitor the safety of these vaccines and now would like to reassure you that, to date, the safety assessment is very encouraging.”
As of Dec. 30, nearly 100 million vaccines have been distributed, with 94% of adverse side effects described as “non-serious,” such as soreness, according to a Jan. 8 statement by the FDA and the Centers for Disease Control and Prevention.