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ANTARES RECEIVES FDA APPROVAL OF XYOSTED (TESTOSTERONE ENANTHATE) INJECTION FOR TESTOSTERONE REPLACEMENT THERAPY IN ADULT MALES
A Novel Subcutaneous Auto Injector Product Approved For Once-Weekly At-Home Therapy
Antares Pharma, Inc. (NASDAQ: ATRS) today announced the approval of XYOSTED (testosterone enanthate) injection by the U.S. Food and Drug Administration (FDA). XYOSTED is the first FDA approved subcutaneous testosterone enanthate product for once-weekly, at-home self-administration with an easy-to-use, single dose, disposable QuickShot auto injector. XYOSTED has been approved in three dosage strengths, 50 mg, 75 mg and 100 mg and is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone (see Indications and Usage below).
BOXED WARNING: BLOOD PRESSURE INCREASES
· XYOSTED can cause blood pressure increases that can increase the risk for major adverse cardiovascular events (MACE), including non-fatal myocardial infarction, non-fatal stroke and cardiovascular death, with greater risk for MACE in patients with cardiovascular risk factors or established cardiovascular disease.
· Before initiating XYOSTED, consider the patient’s baseline cardiovascular risk and ensure blood pressure is adequately controlled.
· Starting approximately 6 weeks after initiating therapy, periodically monitor for and treat new-onset hypertension or exacerbations of pre-existing hypertension in patients on XYOSTED.
· Re-evaluate whether the benefits of XYOSTED outweigh its risks in patients who develop cardiovascular risk factors or cardiovascular disease while on treatment.
· Due to this risk, use XYOSTED only for the treatment of men with hypogonadal conditions associated with structural or genetic etiologies.
A Novel Subcutaneous Auto Injector Product Approved For Once-Weekly At-Home Therapy
Antares Pharma, Inc. (NASDAQ: ATRS) today announced the approval of XYOSTED (testosterone enanthate) injection by the U.S. Food and Drug Administration (FDA). XYOSTED is the first FDA approved subcutaneous testosterone enanthate product for once-weekly, at-home self-administration with an easy-to-use, single dose, disposable QuickShot auto injector. XYOSTED has been approved in three dosage strengths, 50 mg, 75 mg and 100 mg and is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone (see Indications and Usage below).
BOXED WARNING: BLOOD PRESSURE INCREASES
· XYOSTED can cause blood pressure increases that can increase the risk for major adverse cardiovascular events (MACE), including non-fatal myocardial infarction, non-fatal stroke and cardiovascular death, with greater risk for MACE in patients with cardiovascular risk factors or established cardiovascular disease.
· Before initiating XYOSTED, consider the patient’s baseline cardiovascular risk and ensure blood pressure is adequately controlled.
· Starting approximately 6 weeks after initiating therapy, periodically monitor for and treat new-onset hypertension or exacerbations of pre-existing hypertension in patients on XYOSTED.
· Re-evaluate whether the benefits of XYOSTED outweigh its risks in patients who develop cardiovascular risk factors or cardiovascular disease while on treatment.
· Due to this risk, use XYOSTED only for the treatment of men with hypogonadal conditions associated with structural or genetic etiologies.