Merck announced that the FDA has approved a new dosage of Fosamax Plus D (alendronate sodium/cholecalciferol), a single, once-weekly tablet containing Fosamax (alendronate sodium) 70 mg and 5,600 international units (IU) of vitamin D3 (cholecalciferol). Fosamax Plus D is indicated for the treatment of osteoporosis in postmenopausal women.
Sanofi-Aventis said the FDA has approved a supplemental New Drug Application (sNDA) for the anticoagulant Lovenox (enoxaparin sodium injection) for the treatment of patients with acute ST--segment elevation myocardial infarction (STEMI). Lovenox(R) has been shown to reduce the rate of the combined endpoint of recurrent myocardial infarction or death in patients with acute STEMI receiving thrombolysis and being managed medically or with Percutaneous Coronary Intervention (PCI). STEMI is a severe type of heart attack in which an artery is generally completely blocked by blood clot for sufficient time causing heart muscle damage.
Ortho Biotech Products said the FDA has approved the use of Doxil (doxorubicin HCl liposome injection) in combination with Velcade (bortezomib) for injection to treat patients with multiple myeloma who have not previously received Velcade and have received at least one prior therapy.
An FDA advisory panel agreed that MedImmune’s FluMist nasal spray flu vaccine is safe and effective in children 2 and older. The vaccine is currently approved for patients ages 5 to 49. MedImmune is currently seeking approval for FluMist use in patients ages 1 to 5 without a history of wheezing or asthma. Advisory panel members, in a 9 to 6 vote, said company studies show FluMist’s benefits outweighed its risks in children 1 to 5 years old without known respiratory problems. The panel voted 15 to 0 that if a child does wheeze, the vaccine should be used in only those 2 and older. Advisers voted 12 to 3 against recommending FluMist use in wheezy children younger than 2.The FDA isn’t required to follow the advice of its advisory panels but often does. FluMist was first approved in 2003. Sales of the drug reached $36 million in 2006. Last month, MedImmune agreed to be purchased by AstraZeneca for $15.6 billion.
This material may not be published, broadcast, rewritten or redistributed in any form without prior authorization.