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FDA Watch: Approvals for Pfizer, Roche, Amgen, Novartis

Approvals and designations made by the U.S. Food and Drug Administration for the week ended May 18.


* Pfizer Inc.'s Retacrit, a biosimilar version of anemia treatments Procrit and Epogen, from Johnson & Johnson and Amgen Inc., respectively. Retacrit is also approved for use before and after surgery to reduce the chance of needing red blood cell transfusions due to blood loss during surgery.

* Roche Holding AG's subcutaneous formulation of Actemra, for active polyarticular juvenile idiopathic arthritis.

* Amgen and Novartis AG's Aimovig, for adults with migraine.

* Gilead Sciences Inc.'s Truvada, to reduce the risk of sexually acquired HIV-1 in adolescents. The drug is already approved for use in adults.

* AstraZeneca PLC's Lokelma, for adults with hyperkalemia. The drug is already approved in Europe for the same indication.

SNL Image
FDA headquarters in Silver Spring, Md.
Source: Associated Press

* US WorldMeds LLC's Lucemyra, to lessen the severity of opioid withdrawal symptoms in adults. The drug was only approved for up to 14 days of use.

* VentriPoint Diagnostics Ltd.'s VMS+ echocardiography system, for the 3D volumetric analysis of all four chambers of the heart using 2D ultrasound.

* OrthoPediatrics Corp.'s Pediatric Nailing Platform Femur, a surgical system for children with fractured long bones.

* Baxter International Inc.'s Spectrum IQ Infusion System with Dose IQ safety software, designed for bidirectional electronic medical records integration.

* Amphastar Pharmaceuticals Inc. calcium chloride injection 10% in the 10-milliliter Luer-Jet Prefilled Syringe System, a generic calcium chloride injection.

Complete response letters

* Evolus Inc.'s prabotulinumtoxinA, meant to treat glabellar lines, also known as frown lines, in adults. The company plans to resubmit its application within 90 days, addressing the issues related to prabotulinumtoxinA's chemistry, manufacturing and controls processes cited by the FDA.