Teva received an amended approval from FDA today for Plan-B One-Step to be available, without a prescription, for all women 15 years of age and older. The product will now be labeled, “not for sale to those under 15 years of age *proof of age required* not for sale where age cannot be verified.” Teva will make the product available in retail outlets with an onsite pharmacy, in the family planning or female health aisles, and the product will be available for sale during the retailer’s normal operating hours whether the pharmacy is open or not.
Vertex Pharmaceuticals reported a drop in quarterly sales, to $328 million, compared to $439 million for the same period last year, but ISI analyst Mark Schoenebaum wrote Tuesday that he doesn’t expect the slipping numbers will hurt the firm on Wall Street, writing: “VRTX reported what appears to be a solid quarter . . . this has morphed once again into a (good) data story.” The drug maker saw Incivek sales fall 42%, to $205 billion for the quarter. Kalydeco sales rose over 200% to $62 million, compared to $18 million for the same period last year. Schoenebaum noted the company said it expects to have data on its all-oral HCV candidate that combines the company’s nucleotide polymerase inhibitor and Bristol-Myer’s daclatasvir by the end of this year.
FDA announced the approval of Kcentra for the immediate reversal of vitamin K antagonist (VKA) anticoagulation in adults with acute major bleeding. The new product does not require blood group typing and does not need to be thawed, so it can be quickly delivered to patients, the FDA said. CSL Behring manufactures Kcentra.
FDA slapped Boehringer Ingelheim’s Pradaxa with a black box warning today, cautioning that discontinuing treatment increases the risk of stroke.
Former FDA Deputy Commissioner Deborah Autor has left to take a job with generic giant Mylan as SVP for strategic global quality and regulatory policy. Autor was responsible for the Office of Regulatory Affairs and the Office of International Programs. By Pharmalot’s calculations, she oversaw 4,400 employees responsible for inspections, imports and enforcing policy. In a statement released by Mylan, Autor commented: “I am very excited to be joining an organization whose people demonstrate such extraordinary passion and commitment to quality and access to medicine.”
Regulators unveiled a report Thursday saying Amgen drugs Neulasta and Neupogen may help limit exposure to radiation, and may help people survive after a nuclear attack. According to Bloomberg, this is the first time an FDA advisory committee has considered a medical countermeasure for use in a radiological or nuclear incident. In an NIH study, 79% of monkeys who took Neupogen after being exposed to radiation survived, while 41% of monkeys who did not take Neupogen died.