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New Drug Approvals Archive - December 2016

December 2016

December 2

Jardiance (empagliflozin)

New Indication Approved: December 2, 2016

Jardiance (empagliflozin) FDA Approval History

December 6

Avastin (bevacizumab)

New Indication Approved: December 6, 2016

Avastin (bevacizumab) FDA Approval History

December 12

Synjardy (empagliflozin and metformin)

New Formulation Approved: December 12, 2016

Synjardy (empagliflozin and metformin) FDA Approval History

December 14

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.

Eucrisa (crisaborole) FDA Approval History

December 19

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.

Rubraca (rucaparib) FDA Approval History

December 19

Tresiba (insulin degludec)

Patient Population Altered: December 16, 2016

Tresiba (insulin degludec) FDA Approval History

December 23

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.

Spinraza (nusinersen) FDA Approval History

December 27

Adynovate (antihemophilic factor (recombinant) pegylated)

Patient Population Altered: December 22, 2016

Adynovate (antihemophilic factor (recombinant) pegylated) FDA Approval History

New Drug Approvals Archive

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