FDA gives regular approval to Pfizer’s Xalkori
NEW YORK — The Food and Drug Administration has granted regular approval to a new drug made by Pfizer for treating a form of lung cancer, the drug maker said.
Pfizer announced the approval of Xalkori (crizotinib) for anaplastic lymphoma kinase-positive non-small cell lung cancer that has spread to other parts of the body, as detected through testing. Lung cancer causes an estimated 1.4 million deaths around the world each year, according to the International Agency for Research on Cancer. According to Pfizer, more than 6,000 people globally have been treated with Xalkori, including those who received it in clinical trials, while Pfizer estimates that rates of testing for ALK in U.S. lung caner patients are more than 60%.
"Xalkori has dramatically changed the treatment landscape for patients with advanced ALK-positive NSCLC," Pfizer Oncology Business Unit president and general manager Garry Nicholson said. "Achievement of this milestone underscores Pfizer’s commitment to provide physicians with effective cancer therapies for their patients."
Diplomat added to limited-distribution network for Cornerstone Therapeutics’ Bethkis
FLINT, Mich. — Cornerstone Therapeutics has added specialty pharmacy Diplomat to its limited-distribution network for a newly approved treatment for cystic fibrosis, Diplomat said Friday.
Diplomat will distribute Bethkis (tobramycin inhalation solution), which received Food and Drug Administration approval in October for treating chronic bacterial lung infections caused by P. aeruginosa in cystic fibrosis patients.
Cystic fibrosis affects more than 30,000 children and adults, according to the Cystic Fibrosis Foundation, with 1,000 new cases diagnosed each year.
Correction: The original statement from Diplomat incorrectly referred to the name of Cornerstone Therapeutics. This version of the story corrects the original.
Sandoz launches authorized generic version of PharmaDerm’s Solaraze
PRINCETON, N.J. — Sandoz has launched an authorized generic version of a topical drug for treating actinic keratosis, the company said.
Sandoz, the generics arm of Swiss drug maker Novartis, announced the launch of authorized generic diclofenac gel in the 3% strength. The drug is a version of PharmaDerm’s Solaraze.
The drug had sales of $92 million in 2012, according to IMS Health. Authorized generics are branded drugs marketed under their generic names at a discounted price, usually under a contract between the branded drug’s manufacturer and a third-party company.
Actinic keratosis, or AK, is a precancerous condition affecting 58 million Americans that causes thick, scaly or crusty patches of skin.