FDA approves new dosage of MedPointe’s Soma
SOMERSET, N.J. MedPointe Pharmaceuticals has received approval from the Food and Drug Administration for Soma 250 mg as a new dosage of Soma for the relief of discomfort associated with acute, painful musculoskeletal conditions, such as backaches.
Compared to the 350 mg version of Soma, the tolerability of the 250 mg is said to be more favorable and causes less drowsiness. “The clinical benefits of Soma 250 mg are in line with current treatment strategies for back pain which focus on helping patients to return to normal physical activity as quickly as possible,” said Lee Ralph, assistant clinical professor in the Department of Family and Preventative Medicine at the University of California, San Diego and a lead author and investigator for the Soma 250 mg clinical trials.
Back pain has led to health care costs of more than $20 billon each year and as much as $50 billion in indirect costs. The new recommended dosage of the 250 mg version of Soma is three times a day and at bedtime.
Evista gets FDA approval for new use to reduce breast cancer risk
INDIANAPOLIS The Food and Drug Administration has approved a new application for Eli Lilly’s osteoporosis drug Evista. The drug is now indicated as a way to reduce the risk of invasive breast cancer.
The drug’s new use is designed for postmenopausal women with osteoporosis and postmenopausal women at high risk for invasive breast cancer. “The FDA’s decision marks a major milestone. For the first time, postmenopausal women with osteoporosis will have one treatment option that can help address two leading health concerns—osteoporosis and invasive breast cancer,” said Gwen Krivi, vice president of Lilly Research Laboratories.
The approval comes less than a year after the application was submitted to the FDA and also carries a recommendation of the Oncologics Drug Advisory Committee.
Cubist to ask for patent reissue for Cubicin
LEXINGTON, Mass. Cubist Pharmaceuticals is planning on asking U.S. regulators to reissue a patent on the drug Cubicin to block generic competition.
Cubicin is used as a treatment for skin infections and is set to lose its patent in 2016. Cubist is going to ask the U.S. Patent and Trademark Office to correct and reissue a patent regarding the purity level of the compound daptomycin, which is the key ingredient in Cubicin.
On Wednesday, generic manufacturers were allowed to seek approval from the Food and Drug Administration to sell generic versions of the drug. Now, with Cubist seeing corrections from the patent office, the original patent will be removed from the FDA’s registry of information on approved drugs until the mater is handled.