Dalvance receives FDA approval
SILVER SPRING, Md. — The Food and Drug Administration on Friday approved Dalvance (dalbavancin), a new antibacterial drug used to treat adults with acute bacterial skin and skin structure infections, such as staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains) and streptococcus pyogenes.
Dalvance is the first drug to be designated as a qualified infection disease product to receive the agency’s approval. It was granted QIDP status because it is an antibacterial or antifungal human drug intended to treat serious or life-threatening infections, according to the FDA.
Dalvance, which is adminstered intravenously, was granted priority review. The drug’s QIDP designation qualifies it for an additional five years of marketing exclusivity. Dalvance is marketed by Durata Therapeutics, which is based in Chicago.
Lovely Candy Co. announces line expansions
WOODSTOCK, Ill. — The Lovely Candy Co. has expanded its gluten- and GMO-free line with a gluten-free licorice, which it touts as the first gluten-free extruded licorice product in North America.
Branded as Lovely Licorice, the product is marketed to consumers with food sensitivities such as celiac disease. The gluten-free licorice is the brainchild of company founder Mike Nakamura, whose wife has not been able to have licorice because of her gluten-free dietary restraints. Nakamura founded the company in 2013 as a result of her request for licorice she could eat.
“We plan to develop and launch products that have evolved along with consumer needs and preferences,” said Nakamura, who is not only the company’s founder but also its president and CEO. “Today’s confectionery consumer is better educated and has increased demands.”
The company’s growing line of candies recently expanded to include Fudgee Rolls and Seasonal Caramel varieties. The premium wrapped caramels are available in three varieties: caramel apple, chewy chocolate-cherry and chewy chocolate-peppermint. The suggested retailer price for the seasonal 8-ounce box is $6.99, and $12.99 for the seasonal 16-ounce size.
“We have seen dramatic growth and demand for our line of premium, all-natural candies,” added Nakamura. “We have really struck a chord with Lovely Candy’s Consciously Crafted line as retailers realize that many consumers care about what they put in their bodies, whether they are eating a salad or candy. Our candies are made with the best ingredients, so people can enjoy a treat without the artificial flavors, colors, GMOs and high fructose corn syrup you find in many candies.”
The company said that it is already seeing major distribution gains with Lovely Candy Original Chewy Caramels, Lovely Candy Chocolate Swirl Caramels, Lovely Candy Super Fruit Chews (in cranberry, raspberry and blueberry) and Lovely Candy Fruit Chews (in apple, cherry and blackberry), which have a suggested retail price of $5.99 for a 6-ounce stand up pouch.
The entire line is certified gluten-free by the Gluten-Free Certification Organization and also is certified kosher. The caramels contain rBST-free dairy and the fruit chews are vegan.