FDA grants priority review of Zytiga sNDA
RARITAN, N.J. — The Food and Drug Administration has granted priority review to a supplemental new drug application for a drug developed by Janssen Research and Development.
Janssen Research and Development said the regulatory agency granted priority review for Zytiga (abiraterone acetate) administered in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer, who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy. Under the Prescription Drug User Fee Act, the FDA will aim to conclude its review within six months of the sNDA submission. The sNDA was submitted in June, the company said.
"We believe that men with mCRPC whose disease is asymptomatic or mildly symptomatic, for whom chemotherapy may not be immediately necessary, have limited treatment options and that this disease setting represents a critical unmet medical need," said Michael Meyers, VP and compound development team leader for Zytiga. "We are delighted the FDA has granted a priority review designation for our sNDA."
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Coastal Wine Brands debuts Charonge
NAPA, Calif. — Coastal Wine Brands has debuted a new California white wine blended with natural orange flavor.
Charonge, which debuted last month, the wine is zestily fruity with fresh orange blossom, peach/apricot and yellow plum aromas. On the palate, it delivers crisp, wonderfully refreshing orange, papaya and yellow apple flavors that are enlivened in the wine’s long, snappy finish by a slight spritz, the company said.
Charonge carries a suggested retail price of $12 per bottle.
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Purina encourages pets, owners to ‘be happy’
ST. LOUIS — Purina has launched a new line of pet food that is inspired by the enduring happiness pets share with owners.
Be Happy is a dry pet food, available nationwide in cat and dog formulas, which helps support strong bones and teeth, healthy vision and healthy skin and coat, Purina said. The brand portfolio includes two varieties for cats — Deep Sea Duos Crunchies with ocean fish and salmon flavors and Poultry Pair-adise Crunchies with chicken and turkey flavors — as well as two varieties for dogs — beef and chicken.
"We looked at the way our pets see the world and were inspired by how they just seem to instinctively know the secrets to being happy," Be Happy brand manager Aaron Williams said. "We’re celebrating our pets as our happiness heroes. We’ve incorporated this philosophy into everything we do, and are encouraging pet owners to join our happiness movement online."
Really? Same crap in a different bag with a different marketing strategy. Hope this does as well as Pet Promise!!! LOL