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New Drug Approvals Archive - February 2016

February 2016

February 5

Daklinza (daclatasvir)

New Indication Approved: February 5, 2016

Daklinza (daclatasvir) FDA Approval History

February 5

Sernivo (betamethasone dipropionate) Topical Spray

Date of Approval: February 5, 2016
Company: Promius Pharma, LLC
Treatment for: Plaque Psoriasis

Sernivo Spray (betamethasone dipropionate) is a topical corticosteroid indicated for the treatment of mild to moderate plaque psoriasis.

Sernivo (betamethasone dipropionate) FDA Approval History

February 16

Harvoni (ledipasvir and sofosbuvir)

New Indication Approved: February 12, 2016

Harvoni (ledipasvir and sofosbuvir) FDA Approval History

February 19

Briviact (brivaracetam) Tablets, Solution and Injection

Date of Approval: February 19, 2016
Company: UCB, Inc.
Treatment for: Epilepsy

Briviact (brivaracetam) is a selective, high-affinity synaptic vesicle protein 2A ligand and analog of levetiracetam indicated for the treatment of partial-onset seizures in patients with epilepsy.

Briviact (brivaracetam) FDA Approval History

February 19

Ibrance (palbociclib)

Labeling Revision Approved: February 19, 2016

Ibrance (palbociclib) FDA Approval History

February 24

Xeljanz (tofacitinib)

New Dosage Form Approved: February 24, 2016

Xeljanz (tofacitinib) FDA Approval History

February 25

Aczone (dapsone)

New Formulation Approved: February 24, 2016

Aczone (dapsone) FDA Approval History

February 26

Gazyva (obinutuzumab)

New Indication Approved: February 26, 2016

Gazyva (obinutuzumab) FDA Approval History

February 26

Afinitor (everolimus)

New Indication Approved: February 26, 2016

Afinitor (everolimus) FDA Approval History

New Drug Approvals Archive

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