Amneal, South Korea-based Hanmi enter GERD drug deal
BRIDGEWATER, N.J. — U.S. generic drug maker Amneal Pharmaceuticals has entered a deal with South Korean drug maker Hanmi Pharmaceutical to acquire exclusive distribution rights for a Hanmi drug used for treating gastroesophageal reflux disease, Amneal said Monday.
Amneal will acquire rights to Hanmi’s regulatory approval application for esomeprazole strontium delayed-release capsules. The application was filed with the Food and Drug Administration and included bioequivalence testing against AstraZeneca’s Nexium (esomeprazole magnesium) delayed-release capsules. The company’s expect the FDA to decide whether or not to approve the drug in April 2013.
"We are very excited to enter into this partnership with Hanmi, as it gives Amneal the opportunity to introduce a high-quality, low-cost esomeprazole strontium product into the U.S. market, potentially before other generic competitors," Amneal president Chirag Patel said.
Six retailers make YouGov’s BrandIndex ‘Buzz’ list
NEW YORK — YouGov’s BrandIndex has named 25 brands to its "2012 Annual US Top Buzz Rankings," YouGov said.
The index measures public perception of thousands of brands based on interviews with thousands of consumers every day, with more than 2.5 million interviews every year.
Retail brands that made the index in 2012 included online retailer Amazon, in second place; hardware chain Lowe’s, in fifth place; mass merchandiser Target, in seventh place; retail pharmacy chain Walgreens, in 13th place; hardware chain Home Depot, in 18th place; and clothing chain Kohl’s, in 25th place.
FDA approves new use of Pfizer vaccine
NEW YORK — The Food and Drug Administration has approved a new use for a pneumococcal vaccine made by Pfizer, the drug maker said.
Pfizer announced the approval of Prevnar 13 (pneumococcal 13-valent conjugate vaccine [diphtheria CRM197 protein]) for children and adolescents ages 6 years to 17 years for active immunization against the 13 Streptococcus pneumonia serotypes the vaccine covers. For this group, Prevnar 13 is administered as a one-time dose to patients who have never received it.
The approval was the result of an FDA review of a phase-3 trial of the vaccine in 592 older children and adolescents, including those with asthma.