MDRNA receives tentative FDA approval for generic osteoporosis drug
BOTHELL, Wash. The Food and Drug Administration has given tentative approval to a generic version of Novartis Pharmaceuticals Corp.’s osteoporosis drug Miacalcin.
MDRNA announced Monday that it had received tentative approval for its generic calcitonin-salmon spray. It will receive full approval once Apotex’s six-month exclusivity period ends in June 2009.
The branded version of the drug had sales of $147 million, according to MDRNA, based in the Seattle suburb of Bothell, Wash.
Texas congressman asks reason for six-month delay on FDA confiscation of Celsus’ contaminated heparin
WASHINGTON The Food and Drug Administration waited six months to confiscate contaminated supplies of the blood-thinning drug heparin from Cincinnati-based Celsus Labs, and a congressman from Texas wants to know why.
Last month, United States Marshalls seized 11 lots of the drug from Celsus after the company allegedly failed to properly recall it on its own.
Contaminated heparin has been blamed for several hundred adverse reactions and 81 deaths across the country, though no deaths have been linked with Celsus’ heparin. The contamination comes from over-sulfated chondroitin sulfate, which mimics the blood-thinning properties of heparin and was mixed with several lots of the drug using ingredients from China.
Specialty Pharmacy Summit to take place in March
SHORT HILLS, N.J. A large specialty pharmacy network and group-contracting organization will be host of the fifth annual Specialty Pharmacy Summit in March.
Armada Health Care announced Tuesday that the summit would take place at the Wynn Hotel in Las Vegas from March 10 to March 13. Armada expects almost 1,000 people to attend, and they will represent more than 50 percent of the total annual expenditure on specialty pharmacy in the United States. Last year’s summit included more than 500 specialty pharmacy providers, industry-channel partners and representatives of industry-associated vendors, as well as PBMs and insurers.
Armada said the summit would give specialty pharmacy providers an opportunity to evaluate new products, gain knowledge of industry trends and network with peers, payers and vendors.