Drug Approval News, In Brief
Executive Summary
FDA’s recent actions include approval for Horizon’s Rayos delayed-release prednisone and “complete response” letters for two other drugs – Otsuka/Lundbeck’s depot injection of the atypical antipsychotic aripiprazole and Luitpold’s iron deficiency anemia treatment Injectafer.
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Generics Don’t Need To Prove What Isn’t In Brand’s Label – FDA Petition Denial
FDA rejects Horizon’s claims that Rayos (prednisone delayed-release) has a unique therapeutic advantage because of its delivery.
Lundbeck/Otsuka Global Alliance Will Support Lundbeck's Move Into U.S. Psychiatry Market
Two firms will collaborate on the development and marketing of new psychiatric products, including an intramuscular depot formulation of the blockbuster antipsychotic medicineLundbeck Inc. , Abilify.
Injectafer Rejected For First-Line Use; Promising For Second-Line, Panel Says
Luitpold's Injectafer should be reserved for second-line use for treatment of iron deficiency anemia in postpartum patients and those with heavy uterine bleeding, FDA's Drug Safety and Risk Management Advisory Committee recommended Feb. 1