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Approvals for Roche, Allergan; designations for AstraZeneca, Iterum Therapeutics

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Approvals for Roche, Allergan; designations for AstraZeneca, Iterum Therapeutics

Approvals and designations made by the U.S. Food and Drug Administration for the week ended March 22.

Approvals

* Roche Holding AG's Tecentriq in combination with chemotherapy drugs carboplatin and etoposide, as a first-line treatment for adults with extensive-stage small cell lung cancer.

* Allergan PLC and Pfizer Inc.'s Avycaz, for children and infants with complicated intra-abdominal infections, or cIAI, in combination with metronidazole, and complicated urinary tract infections, or cUTI. Avycaz is already approved for patients 18 years old and up with cUTI including pyelonephritis, and cIAI in combination with metronidazole.

* Sage Therapeutics Inc.'s Zulresso for postpartum depression.

* Jazz Pharmaceuticals plc's Sunosi for excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea.

* Impulse Dynamics NV's Optimizer Smart system for patients with chronic, moderate-to-severe heart failure who cannot use other devices.

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

Complete response letters

* Sanofi and Lexicon Pharmaceuticals Inc.'s Zynquista for type 1 diabetes.

Fast track

* Iterum Therapeutics PLC's sulopenem for community-acquired bacterial pneumonia, acute bacterial prostatitis, gonococcal urethritis and pelvic inflammatory disease.

Other designations

* Orphan drug, for AstraZeneca PLC's saracatinib, for idiopathic pulmonary fibrosis.

* Qualified infectious disease product, for Iterum Therapeutics' sulopenem, for community-acquired bacterial pneumonia, acute bacterial prostatitis, gonococcal urethritis and pelvic inflammatory disease.