FDA Plan To Remove Generic Status From ADHD Medication Faces Opposition From Drugmakers
Meanwhile, news outlets cover other pharmaceutical news from Novartis, GlaxoSmithKline and Merck.
Stat:
Generic Drug Makers Challenge FDA Plan To Withdraw Their ADHD Pills
Two drug makers — Mallinckrodt and Lannett — are fighting the US Food and Drug Administration over a plan the agency announced last week to withdraw their generic versions of the Concerta pill for attention deficit disorder. Mallinckrodt is trying to contest the move in court, while Lannett plans to seek a hearing in hopes of convincing the agency to change its mind. The agency took this step after determining the generic drugs were not equivalent to the brand-name pill, an issue that actually arose two years ago and prompted the FDA to downgrade regulatory ratings for the copycat drugs. (Silverman, 10/24)
The Wall Street Journal:
Novartis Profit Helped By GlaxoSmithKline Joint Venture
Novartis AG said net income increased in the third quarter thanks to proceeds from its consumer health care joint venture with GlaxoSmithKline PLC, helping to offset declining revenue and heavy investment in its new heart-failure medicine and its ailing eye-care unit. (Roland, 10/25)
The Wall Street Journal:
Merck Drug Gets FDA Approval As A First-Line Lung Cancer Treatment
Merck & Co.’s immunotherapy cancer drug Keytruda received U.S. Food and Drug Administration approval as a first-line treatment for certain lung cancer patients. The approval is for patients with metastatic non-small cell lung cancer whose tumors have high PD-L1 expression, with no EGFR or ALK genomic tumor aberrations. The new indication means Keytruda can be an initial treatment instead of chemotherapy for these patients. (Beckerman, 10/24)
