LONDON, Nov. 19, 2008-On 18 November 2008, the US FDA responded to AstraZeneca’s Citizen Petition surrounding the company’s concern about the approval of any generic version of Pulmicort Respules (budesonide inhalation suspension). While the FDA…
FDA Responds to AstraZeneca’s Citizen Petition — FDA Also Grants Approval for a Generic Version of Pulmicort Respules
FDA Approves Banzel (rufinamide) as Adjunctive Treatment for Severe Epilepsy Disorder
WOODCLIFF LAKE, N.J., November 14, 2008/PRNewswire/ –Eisai Corporation of North America announced today that the U.S. Food and Drug Administration (FDA) approved Banzel (rufinamide) for the adjunctive treatment of seizures associated with…
FDA Approves Low-dose Regimen of Premarin Vaginal Cream to Treat Moderate to Severe Postmenopausal Dyspareunia - Painful Sexual Intercourse
COLLEGEVILLE, Pa., Nov. 13 /PRNewswire-FirstCall/ — Premarin (conjugated estrogens) Vaginal Cream 0.5 g has been approved by the U.S. Food and Drug Administration (FDA) for a new indication and a new less frequent twice-weekly dosing regimen to…
FDA Approves Low-dose Regimen of Premarin Vaginal Cream to Treat Moderate to Severe Postmenopausal Dyspareunia - Painful Sexual Intercourse
COLLEGEVILLE, Pa., Nov. 13 /PRNewswire-FirstCall/ — Premarin (conjugated estrogens) Vaginal Cream 0.5 g has been approved by the U.S. Food and Drug Administration (FDA) for a new indication and a new less frequent twice-weekly dosing regimen to…
FDA Approves 30-Minute Onset of Action for Focalin XR
Data indicate Focalin XR provides rapid and significant improvements in attention, behavior and academic productivity at 30 minutes post-dose
EAST HANOVER, N.J., November 12, 2008 /PRNewswire/ — The US Food and Drug Administration (FDA) has…
FDA Approves 30-Minute Onset of Action for Focalin XR
Data indicate Focalin XR provides rapid and significant improvements in attention, behavior and academic productivity at 30 minutes post-dose
EAST HANOVER, N.J., November 12, 2008 /PRNewswire/ — The US Food and Drug Administration (FDA) has…
EKR Therapeutics Broadens Its Ready-to-Use Cardene I.V. Product Offerings with FDA Approval of Double Concentration Premixed I.V. Bags
BEDMINSTER, N.J.–(BUSINESS WIRE)–Nov 11, 2008 - EKR Therapeutics, Inc., a specialty pharmaceutical company focused on providing novel products for the acute-care hospital setting, today announced that it received approval from the U.S. Food and…
EKR Therapeutics Broadens Its Ready-to-Use Cardene I.V. Product Offerings with FDA Approval of Double Concentration Premixed I.V. Bags
BEDMINSTER, N.J.–(BUSINESS WIRE)–Nov 11, 2008 - EKR Therapeutics, Inc., a specialty pharmaceutical company focused on providing novel products for the acute-care hospital setting, today announced that it received approval from the U.S. Food and…
FDA Approves Ranexa for First Line Anti Anginal Use
PALO ALTO, Calif., Nov. 6 /PRNewswire-FirstCall/ — CV Therapeutics, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved a new, first line indication for Ranexa (ranolazine extended-release tablets) for the treatment…
FDA Approves Additional Indication for Norditropin for Small for Gestational Age (SGA) in Children
PRINCETON, N.J., November 04, 2008 /PRNewswire-FirstCall/ –Children born with a condition that can prevent them from growing to a normal height now have a new treatment option available with the approval of Norditropin (somatropin [rDNA origin]…
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