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New Drug Approvals Archive - June 2017

See also: New Indications and Dosage Forms for June 2017

June 2017

Gleolan (aminolevulinic acid hydrochloride) Oral Solution

Date of Approval: June 6, 2017
Company: NX Development Corp.
Treatment for: Optical Imaging During Glioma Surgery

Gleolan (aminolevulinic acid hydrochloride) is an optical imaging agent indicated for use in patients with glioma as an adjunct for the visualization of malignant tissue during surgery.

Symjepi (epinephrine) Injection

Date of Approval: June 15, 2017
Company: Adamis Pharmaceuticals Corporation
Treatment for: Allergic Reaction

Symjepi (epinephrine) is a non-selective alpha and betaadrenergic receptor agonist in a single-dose, pre-filled syringe for use the emergency treatment of allergic reactions (Type I) including anaphylaxis.

Baxdela (delafloxacin) Tablets and Injection

Date of Approval: June 19, 2017
Company: Melinta Therapeutics
Treatment for: Skin and Structure Infection, Pneumonia

Baxdela (delafloxacin) is a fluoroquinolone antibacterial indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP) caused by designated susceptible bacteria.

Cotempla XR-ODT (methylphenidate) Extended-Release Orally Disintegrating Tablets

Date of Approval: June 19, 2017
Company: Neos Therapeutics, Inc.
Treatment for: Attention-Deficit/Hyperactivity Disorder (ADHD)

Cotempla XR-ODT (methylphenidate) is a once-daily, extended-release, orally disintegrating tablet formulation of the central nervous system (CNS) stimulant methylphenidate indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age.

Mydayis (amphetamine mixed salts)

Date of Approval: June 20, 2017
Company: Shire plc
Treatment for: Attention Deficit Hyperactivity Disorder (ADHD)

Mydayis (amphetamine mixed salts) is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 13 years and older.

Rituxan Hycela (rituximab and hyaluronidase human) Injection

Date of Approval: June 22, 2017
Company: Genentech, Inc.
Treatment for: Follicular Lymphoma; Diffuse Large B-Cell Lymphoma; Chronic Lymphocytic Leukemia

Rituxan Hycela (rituximab and hyaluronidase human) is a subcutaneous monoclonal antibody and hyaluronidase human formulation for the treatment of adult patients with follicular lymphoma, diffuse large B-cell lymphoma (DLBCL), and chronic lymphocytic leukemia (CLL).

Haegarda (C1 esterase inhibitor (human)) Subcutaneous Injection - formerly CSL830

Date of Approval: June 22, 2017
Company: CSL Behring
Treatment for: Hereditary Angioedema

Haegarda (C1 esterase inhibitor (human)) is a low-volume subcutaneous (SC) C1-esterase inhibitor (C1-INH) replacement therapy for routine prophylaxis to prevent Hereditary Angioedema (HAE) attacks in patients 6 years of age and older.

Bevyxxa (betrixaban) Capsules

Date of Approval: June 23, 2017
Company: Portola Pharmaceuticals Inc.
Treatment for: Prevention of Venous Thromboembolism

Bevyxxa (betrixaban) is an oral, once-daily Factor Xa inhibitor anticoagulant for the extended-duration prophylaxis of venous thromboembolism (VTE) in at-risk adult patients hospitalized for an acute medical illness.

Triptodur (triptorelin) Injection

Date of Approval: June 29, 2017
Company: Arbor Pharmaceuticals, LLC
Treatment for: Precocious Puberty

Triptodur (triptorelin) is a gonadotropin releasing hormone (GnRH) agonist indicated for the treatment of pediatric patients with central precocious puberty.

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