Antares Pharma files Quickshot Testosterone NDA with US FDA for standard review.
M2 EQUITYBITES-February 28, 2017-Antares Pharma files Quickshot Testosterone NDA with US FDA for standard review
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Pharmaceutical products company Antares Pharma Inc (NasdaqCM:ATRS) said on Monday that its New Drug Application (NDA) for QuickShot Testosterone (QST) has been accepted for standard review by the US Food and Drug Administration (FDA) for the treatment of hypogonadism.
The company said QuickShot Testosterone (QST) is a drug-device combination product for the delivery of testosterone enanthate using a subcutaneous auto injector to treat adult men with low testosterone associated with a diagnosed condition known as hypogonadism. The investigational subcutaneous testosterone enanthate auto iself-administered testosterone replacement option is designed to be injected at home, on a weekly basis.
In conjunction, the US FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of 20 October 2017, ten months from the official NDA submission. The PDUFA date is the target date for the US FDA to complete its review of the NDA.
According to the company, the proprietary QuickShot auto injector is designed to allow rapid subcutaneous self-administration of highly viscous drugs such as testosterone and biologics using high spring pressure through a fine gauge needle. The QuickShot auto injector can provide the patient with the ease and speed of self-administration, comfort and discretion.
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|Publication:||M2 EquityBites (EQB)|
|Date:||Feb 28, 2017|
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