Bionovo receives CMC approval for Menerba
EMERYVILLE, Calif. The Food and Drug Administration has approved a manufacturing plan for a drug to treat hot flashes in menopausal women.
Bionovo said Thursday that the FDA had accepted its chemistry, manufacturing and controls plan for the drug Menerba. The decisions and agreements are considered binding on the company and the FDA.
“This CMC approval represents a revolutionary set of ‘firsts,’” Bionovo chairman and CEO Isaac Cohen said. “This is the first time that the FDA’s botanical drug development CMC guidance has been applied to an oral drug in a major indication.”
Loveable book character now in gummy vitamins
SAN CLEMENTE, Calif. Hero Nutritional Products on Tuesday announced the launch of "Clifford, The Big Red Dog" gummy vitamins for children.
"Hero Nutritionals shares a common goal with Scholastic, the publisher of ‘Clifford, The Big Red Dog,’ a well-loved children’s icon for 50 years," stated Jennifer Hodges, Hero Nutritional Products CEO. "Clifford promotes good citizenship, manners and education, and Hero Nutritional Products promotes wellness and nutrition, both providing the building blocks for normal healthy growth and development. … Hero’s goal of promoting health goes hand in hand with Clifford’s 10 ‘Be Big’ ideas.”
"Clifford, The Big Red Dog" gummy vitamins have high levels of folic acid and zinc and contain 100% of the recommended children’s daily amount of vitamin D per serving, and contain natural vitamin E and vitamin C. The gummy vitamins also have omega oils made with cranberry seeds for healthy normal development of children.
"Clifford, The Big Red Dog" gummy vitamins will be available in food, drug, grocery and mass merchandise stores including Target, Walgreens, Lewis Drug and Rite Aid.
A50-count (25 serving) bottle retails for a suggested $7.99 and will come in two multivitamin + brain health varieties including the original multi-fruit flavor and a new sweet and tart sour flavor. Special promotions can be found on the Clifford vitamin website.
FDA approves multiple sclerosis drug Gilenya
SILVER SPRING, Md. The Food and Drug Administration has approved a drug for reducing relapses in patients with multiple sclerosis.
The FDA announced Wednesday the approval of Swiss drug maker Novartis’ Gilenia (fingolimod) capsules, saying it was the first oral drug that can slow the progression of disability in patients with MS and offered an alternative to injected drugs.
Around 400,000 people in the United States and 2.1 million worldwide have MS, according to the National Multiple Sclerosis Society.