Takeda files for approval of alogliptin-metformin combination tablet
OSAKA, Japan — A U.S. subsidiary of Takeda Pharmaceutical has filed for regulatory approval of a drug designed to treat Type 2 diabetes, the company said.
The Takeda Global Research and Development Center filed with the Food and Drug Administration for approval of an alogliptin-metformin combination tablet. The company expects the FDA to review the application within the next 10 months.
"This [new drug application] submission further extends Takeda’s commitment to offering patients with Type 2 diabetes a range of therapeutic options to help them manage their condition," Takeda Global Research and Development Center VP clinical science Thomas Strack said. "The worldwide incidence of Type 2 diabetes continues to expand at a rapid rate, and we continue our research into additional medicines to treat these patients."
FDA approves first drug for insomnia with middle-of-night waking, difficulty returning to sleep
SILVER SPRING, Md. — The Food and Drug Administration has approved the first drug for insomnia in which patients wake in the middle of the night and have trouble returning to sleep.
The agency announced Wednesday the approval of Intermezzo (zolpidem tartrate) sublingual tablets, made by Port Richmond, Calif.-based Transcept Pharmaceuticals. The drug contains the same active ingredient as Sanofi’s Ambien but at a lower dose. Zolpidem already has lost patent protection, allowing other companies not only to make generic versions of it, but also to develop "branded generics" that are novel formulations of it, as Transcept has done.
"For people whose insomnia causes them to wake in the middle of the night with difficulty returning to sleep, this new medication offers a safer choice than taking a higher dose of zolpidem upon waking," FDA Center for Drug Evaluation and Research deputy center director Robert Temple said. "With this lower dose there is less risk of a person having too much drug in the body upon waking, which can cause dangerous drowsiness and impair driving."
Pfizer to sell Lipitor directly by mail
NEW YORK — Pfizer is looking to sell its top-selling cholesterol drug directly to consumers at a greatly reduced price after the patent expires, according to published reports.
The Wall Street Journal reported that Pfizer would partner with health plans to sell Lipitor (atorvastatin) directly to consumers through the mail when the drug’s patent expires at the end of the month, opening the drug to generic competition.
Lipitor has sales of more than $7 billion a year in the United States, according to IMS Health, but Pfizer’s sales are likely to take a dip when India’s Ranbaxy Labs launches its long-awaited generic version.