New Drug Approvals Archive - June 2017

Aristada (aripiprazole lauroxil)

New Dosage Regimen: June 5, 2017

• FDA Approves Two-Month Aristada for Treatment of Schizophrenia

Aristada (aripiprazole lauroxil) FDA Approval History

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.

• FDA Approves Gleolan (aminolevulinic acid hydrochloride) as an Optical Imaging Agent in Patients with Gliomas

Gleolan (aminolevulinic acid hydrochloride) FDA Approval History

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.

• Adamis Pharmaceuticals Receives FDA Approval for Symjepi (epinephrine) Pre-Filled Syringe

Symjepi (epinephrine) FDA Approval History

Dysport (abobotulinumtoxinA)

New Indication Approved: June 14, 2017

• Ipsen Announces FDA approval of Dysport (abobotulinumtoxinA) for the Treatment of Lower Limb Spasticity in Adults

Dysport (abobotulinumtoxinA) FDA Approval History

Darzalex (daratumumab)

New Indication Approved: June 16, 2017

• Genmab Announces U.S. FDA Approval of Darzalex (daratumumab) in Combination with Pomalidomide and Dexamethasone for Relapsed or Refractory Multiple Myeloma

Darzalex (daratumumab) FDA Approval History

Baxdela (delafloxacin) Tablets and Injection

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

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

• Melinta Therapeutics Announces FDA Approval of Baxdela (delafloxacin) for Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

Baxdela (delafloxacin) FDA Approval History

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.

• Neos Therapeutics Announces FDA Approval of Cotempla XR-ODT (methylphenidate) Extended-Release Orally Disintegrating Tablets for the Treatment of ADHD in Patients 6 to 17 Years Old

Cotempla XR-ODT (methylphenidate) FDA Approval History

Mydayis (amphetamine mixed salts) - formerly SPD465

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.

• FDA Approves Mydayis (mixed salts of a single-entity amphetamine product) – A New Once-Daily Option for ADHD

Mydayis (amphetamine mixed salts) FDA Approval History

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).

• FDA Approves Rituxan Hycela (rituximab and hyaluronidase human) for Subcutaneous Injection in Certain Blood Cancers

Rituxan Hycela (rituximab and hyaluronidase human) FDA Approval History

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 to prevent Hereditary Angioedema (HAE) attacks.

• FDA Approves Haegarda - First Subcutaneous C1 Esterase Inhibitor for Hereditary Angioedema

Haegarda (C1 esterase inhibitor (human)) FDA Approval History

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.

• FDA Approves Bevyxxa (betrixaban) for Hospital and Extended Duration Prevention of Venous Thromboembolism (VTE) in Acutely Ill Medical Patients

Bevyxxa (betrixaban) FDA Approval History

Vectibix (panitumumab)

New Indication Approved: June 29, 2017

• FDA Approves Vectibix (panitumumab) for Use in Wild-Type RAS Metastatic Colorectal Cancer

Vectibix (panitumumab) FDA Approval History

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.

• Arbor Pharmaceuticals, LLC Announces FDA Approval for Triptodur (triptorelin)

Triptodur (triptorelin) FDA Approval History