New Drug Approvals Archive - April 2015

Corlanor (ivabradine) Tablets

Date of Approval: April 15, 2015
Company: Amgen Inc.
Treatment for: Chronic Heart Failure

Corlanor (ivabradine) is a hyperpolarization-activated cyclic nucleotide-gated channel blocker indicated for the treatment of chronic heart failure.

• FDA Approves Corlanor (ivabradine) to Treat Heart Failure

Corlanor (ivabradine) FDA Approval History

Glatopa (glatiramer acetate) Injection

Date of Approval: April 16, 2015
Company: Sandoz Inc.
Treatment for: Multiple Sclerosis

Glatopa (glatiramer acetate) is a generic version of Copaxone, an immunomodulator drug for the treatment of patients with relapsing-forms of multiple sclerosis.

• FDA Approves Glatopa (glatiramer acetate) as the First Generic Competitor to Copaxone

Glatopa (glatiramer acetate) FDA Approval History

Minocin (minocycline)

New Formulation Approved: April 17, 2015

• FDA Approves New Formulation of Minocin (minocycline) for Injection

Aggrastat (tirofiban hydrochloride)

New Dosage Regimen: April 21, 2015

• Medicure Announces Approval of Expanded Dosing Time For Aggrastat

Cyramza (ramucirumab)

New Indication Approved: April 24, 2015

• FDA Approves Cyramza (Ramucirumab) for Use with FOLFIRI in Second-Line Treatment of Metastatic Colorectal Cancer

Cyramza (ramucirumab) FDA Approval History

Kybella (deoxycholic acid) Injection - formerly ATX-101

Date of Approval: April 29, 2015
Company: Allergan, Inc.
Treatment for: Submental Fullness

Kybella (deoxycholic acid) is a cytolytic drug indicated to improve the appearance of fullness associated with submental fat (double chin).

• FDA Approves Kybella (deoxycholic acid) to Treat Submental Fullness, or 'Double Chin'

Kybella (deoxycholic acid) FDA Approval History

Ixinity (coagulation factor IX (recombinant))

Date of Approval: April 29, 2015
Company: Emergent BioSolutions Inc.
Treatment for: Hemophilia B

Ixinity (coagulation factor IX (recombinant)) is a clotting factor IX therapy indicated to prevent bleeding in patients with hemophilia B.

• Emergent BioSolutions Announces FDA Approval of Ixinity [coagulation factor IX (recombinant)] for Hemophilia B

Ixinity (coagulation factor IX (recombinant)) FDA Approval History

Breo Ellipta (fluticasone and vilanterol)

New Indication Approved: April 30, 2015

• FDA Approves Breo Ellipta (fluticasone furoate/vilanterol) for Asthma

Breo Ellipta (fluticasone and vilanterol) FDA Approval History

Raplixa (fibrin sealant [human])

Date of Approval: April 30, 2015
Company: ProFibrix BV
Treatment for: Hemostasis

Raplixa (fibrin sealant [human]) is a spray-dried fibrin sealant used to help control bleeding during surgery.

• FDA Approves Raplixa (fibrin sealant [human]) to Control Bleeding During Surgery

Raplixa (fibrin sealant [human]) FDA Approval History

Tuzistra XR (chlorpheniramine polistirex and codeine polistirex) Extended Release Oral Suspension

Date of Approval: April 30, 2015
Company: Vernalis plc and Tris Pharma Inc.
Treatment for: Cold Symptoms, Cough

Tuzistra XR (codeine polistirex and chlorpheniramine polistirex) is an extended-release opiate agonist antitussive and histamine-1 (H1) receptor antagonist combination indicated for the relief of cough and symptoms associated with upper respiratory allergies or the common cold.

• Vernalis and Tris Pharma Receive FDA Approval for Tuzistra XR (codeine polistirex and chlorpheniramine polistirex)

Tuzistra XR (chlorpheniramine polistirex and codeine polistirex) FDA Approval History