FDA tentatively approves Sun’s bone cancer generic
ROCKVILLE, Md. The Food and Drug Administration has given tentative approval to a generic version of a bone cancer drug.
The agency announced the tentative approval of Sun Pharmaceutical Industries’ zoledronic acid injection in the 4-mg strength. The drug is a generic version of Novartis’ Zometa, which had global sales of $1.38 billion, according to Novartis financial data.
The FDA gives tentative approval to generic drugs that meet its conditions for marketability, but whose branded counterparts still have patent protection, thus preventing full approval until the patent expires. Novartis’ patent on Zometa will expire in 2012, according to the FDA’s Orange Book database.
D2 Pharma Consulting launches interactive Web site
ST. CHARLES, Mo. D2 Pharma Consulting on Wednesday launched its new interactive Web site — www.D2Rx.com. The Web site will integrate a “D2Rx Blog” with up-to-date industry information focused on keeping pharmaceutical and biotech executives current with industry information.
“We believe it’s our highly experienced, hands-on approach that differentiates us from similar service providers,” stated Dean Erhardt, D2 principal.
D2 provides outsourced solutions to emerging and established companies for the commercialization, distribution and marketing of pharmaceuticals, medical devices and biotech pharmaceuticals. Together with their strategic partners, D2 offers commercialization services for the clients’ approved products across the traditional, medical device and specialty pharmaceutical categories.
“D2 has the experience and knowledge to facilitate the commercialization process for the emerging BioPharma and Pharma companies,” stated fellow D2 principal Dan Steiber. “Our site is designed to assist both established and emerging organizations on key issues that may impact their commercialization efforts.”
FDA approves Hib vaccine from GSK
PHILADELPHIA In response to a U.S. shortage of a vaccine to protect infants from Haemophilus influenzae Type b, GlaxoSmithKline has received accelerated approval from the Food and Drug Administration for Hiberix as a booster dose in children 15 months through 4 years of age.
Hib is an often severe and potentially deadly bacterial infection that can cause meningitis.
The Hib vaccine [Haemophilus b conjugate vaccine (tetanus toxoid conjugate)] shortage began in 2007 when another vaccine manufacturer temporarily suspended manufacturing of its Hib-containing vaccines. This led the Centers for Disease Control and Prevention to recommend temporary deferral of the booster dose for healthy children not at increased risk for Hib disease, GSK said.
Earlier this summer, the CDC reinstated the routine Hib booster dose due to an increase in supply. However, supply was not sufficient to support a mass catch-up effort for the millions of children who did not receive the booster dose during the shortage. Hiberix will help restore supply so children who missed the booster dose can get caught-up. Additionally, children coming in for routine visits can receive the Hib booster shot on time.
The CDC recommends that children receive the complete Hib vaccination series. The series includes a booster dose in the second year of life, in addition to a complete primary series of immunization in infants.
The review of Hiberix for the booster indication was conducted under accelerated approval regulations due to the shortage of Hib vaccine supply in the United States. GSK submitted safety and efficacy information from clinical studies conducted outside the United States for this review. In those studies, a booster dose of Hiberix following primary series vaccination provided protective levels of antibodies against Hib bacteria, regardless of the priming vaccine that was used.
“We are pleased that we were able to respond to this public health need,” said Peter Lammers, VP U.S. vaccines at GlaxoSmithKline. “GSK was able to act swiftly to increase supply of Hib vaccine so that children can complete the vaccination schedule as recommended by the CDC.”
More than 54 million doses of Hiberix have been distributed outside the United States since the 1996 launch in Germany, and the vaccine currently is registered in nearly 100 countries.
The vaccine is expected to be available within several weeks.