SUPPLIER NEWS — The Food and Drug Administration has approved a drug made by Merck for Type 2 diabetes, the drug maker said. Merck announced the approval of Janumet XR (sitagliptin and metformin hydrochloride) extended-release tablets as a once-daily treatment for the disease.
The FDA has approved a drug made by Novartis that is designed to prevent tumors in the gastrointestinal tract from recurring after surgical removal, the agency said. The FDA approved Novartis’ Gleevec (imatinib) for adults who have had gastrointestinal stromal tumors, or GIST, removed. The drug was specifically approved for people whose tumors are known as CD117-positive, which includes 95% of all GIST tumors. The drug was originally approved in 2001 for a type of leukemia.
Takeda Pharmaceutical has launched a drug for treating high blood pressure in adults, the company said. Takeda announced the availability of Edarbyclor (azilsartan medoxomil and chlorthalidone), a once-daily tablet for hypertension.
The FDA has approved a head lice treatment made by Sanofi, the drug maker said. Sanofi announced the approval of Sklice (ivermectin) lotion in the 0.5% strength for patients ages 6 months and older. According to Sanofi, head lice affects an estimated 6 million to 12 million children ages 3 to 11 years and costs as much as $1 billion in lost school days and lost work for parents.
The FDA has given tentative approval to a generic cholesterol drug made by Mylan, the drug maker said. Mylan announced that it had received tentative approval for a generic version of Pfizer’s Lipitor (atorvastatin calcium) in the 10-mg, 20-mg, 40-mg and 80-mg strengths. A tentative approval means that the drug meets the FDA’s conditions for approval, but the agency can’t give final approval because of outstanding patent- and exclusivity-related issues. Ranbaxy Labs, which won approval for the first generic version of the drug in November, currently has the exclusive right to compete with Pfizer’s version and will until May. Lipitor had sales of $8.2 billion in 2011, according to IMS Health.