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New Drug Approvals Archive - April 2015

See also: New Indications and Dosage Forms for April 2015

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.

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.

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).

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.

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.

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.

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