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FDA News Briefs for Tuesday, May 28, 2019

May 28, 2019

These Food and Drug Administration (FDA) developments came in last week:


FDA Approves Gene Therapy for Treatment of Spinal Muscular Atrophy

The FDA has approved Zolgensma (onasemnogene abeparvovec-xioi; AveXis Inc.), the first gene therapy approved to treat children younger than two years of age with spinal muscular atrophy (SMA). Zolgensma is an adeno-associated virus vector-based gene therapy that targets the cause of SMA; it is a one-time intravenous administration. More Information.


FDA Approves Piqray for Treatment of Breast Cancer

The FDA has approved Piqray (alpelisib; Novartis) to be used in combination with the FDA-approved endocrine therapy fulvestrant, to treat both postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer (as detected by an FDA-approved test) following progression on or after an endocrine-based regimen. More Information.


FDA Clears Synovasure Lateral Flow Test Kit for Marketing

The FDA has granted de novo marketing clearance for the Synovasure Lateral Flow Test Kit (CD Diagnostics Inc.) as an aid for the detection of periprosthetic joint infection in the synovial fluid of patients being evaluated for revision surgery, which is surgery performed to replace or compensate for a failed implant. More Information.


Recall: Compounded Drugs by Pharm D Solutions

Pharm D Solutions LLC has initiated a voluntary recall of all sterile compounded drug products. These drug products are being voluntarily recalled due to concerns that practices at the pharmacy have the potential to pose a risk of contamination to products that are intended to be sterile. These concerns arose following a routine inspection of the pharmacy by FDA. More Information.


Recall: lntegra LifeSciences CSF Drainage Systems

lntegra LifeSciences is recalling the LimiTorr & MoniTorr Drainage Systems due to reported complaints regarding: “piece breaking off at connection point,” “broken manifold-stopcock,” “stopcock problem,” “connection where the external transducer is attached to the transducer holder bracket broke off,” and “transducer attachment on the LimiTorr/MoniTorr has cracked and was leaking CSF.” This breakage occurs when there is over-bending of the stopcock most often related to the use of LimiTorr or MoniTorr in combination with a Fluid Filled Transducer. More Information.