New Drug Approvals Archive - December 2016
New Indication Approved: December 2, 2016
- FDA Approves Jardiance (empagliflozin) to Reduce Cardiovascular Death in Adults with Type 2 Diabetes
New Indication Approved: December 6, 2016
Read more: 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
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.
Read more: 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 advanced mutant BRCA ovarian cancer.
Read more: 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
Spinraza (nusinersen) Injection
Date of Approval: December 23, 2016
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.
Read more: 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