New Drug Approvals Archive - December 2016

Jardiance (empagliflozin)

New Indication Approved: December 2, 2016

• FDA Approves Jardiance (empagliflozin) to Reduce Cardiovascular Death in Adults with Type 2 Diabetes
• Jardiance (empagliflozin) FDA Approval History

Avastin (bevacizumab)

New Indication Approved: December 6, 2016

• FDA Approves Avastin (bevacizumab) Plus Chemotherapy for a Specific Type of Advanced Ovarian Cancer
• Avastin (bevacizumab) FDA Approval History

Synjardy (empagliflozin and metformin)

New Formulation Approved: December 12, 2016

• FDA Approves Synjardy XR (empagliflozin/metformin hydrochloride extended-release) for Adults with Type 2 Diabetes
• Synjardy (empagliflozin and metformin) FDA Approval History

Eucrisa (crisaborole) Topical Ointment

Date of Approval: December 14, 2016
Company: Pfizer, Inc.
Treatment for: Atopic Dermatitis

Eucrisa (crisaborole) is a novel, non-steroidal topical anti-inflammatory phosphodiesterase-4 (PDE-4) inhibitor indicated for the treatment of mild-to-moderate atopic dermatitis.

• FDA Approves Eucrisa (crisaborole) for Eczema
• Eucrisa (crisaborole) FDA Approval History

Rubraca (rucaparib) Tablets

Date of Approval: December 19, 2016
Company: Clovis Oncology, Inc.
Treatment for: Ovarian Cancer

Rubraca (rucaparib) is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for the treatment of patients with deleterious BRCA mutation (germline and/or somatic)-associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies; and for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.

• FDA Grants Accelerated Approval to Rubraca (rucaparib) for Advanced Ovarian Cancer
• Rubraca (rucaparib) FDA Approval History

Tresiba (insulin degludec)

Patient Population Altered: December 16, 2016

• Novo Nordisk Receives FDA Approval of Tresiba (insulin degludec) for Use in Children and Adolescents With Diabetes
• Tresiba (insulin degludec) FDA Approval History

Spinraza (nusinersen) Injection

Date of Approval: December 23, 2016
Company: Biogen
Treatment for: Spinal Muscular Atrophy

Spinraza (nusinersen) is a survival motor neuron-2 (SMN2)-directed antisense oligonucleotide indicated for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients.

• FDA Approves Spinraza (nusinersen) for Spinal Muscular Atrophy
• Spinraza (nusinersen) FDA Approval History

Adynovate (antihemophilic factor (recombinant) pegylated)

Patient Population Altered: December 22, 2016

• Shire Announces FDA Approval of Adynovate [Antihemophilic Factor (Recombinant), PEGylated] for Use in Children and Surgical Settings
• Adynovate (antihemophilic factor (recombinant) pegylated) FDA Approval History

Rubraca (rucaparib)

New Indication Approved: April 6, 2018

• Rubraca (rucaparib) Approved in the U.S. as Maintenance Treatment of Recurrent Ovarian Cancer
• Rubraca (rucaparib) FDA Approval History