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New Drug Approvals Archive - March 2018

March 2018

Otiprio (ciprofloxacin)

New Indication Approved: March 2, 2018
Treatment for: Tympanostomy Tube Placement Surgery; Acute Otitis Externa

Read more: Otiprio (ciprofloxacin) FDA Approval History

Trogarzo (ibalizumab-uiyk) Injection

Date of Approval: March 6, 2018
Company: TaiMed Biologics USA Corp.
Treatment for: HIV Infection

Trogarzo (ibalizumab-uiyk) is a CD4-directed post-attachment HIV-1 inhibitor for the treatment of multidrug resistant human immunodeficiency virus-1 (HIV-1) infection in heavily treatment-experienced adults.

Read more: Trogarzo (ibalizumab-uiyk) FDA Approval History

Lucentis (ranibizumab)

New Dosage Form Approved: March 20, 2018
Treatment for: Macular Degeneration; Macular Edema; Diabetic Macular Edema; Diabetic Retinopathy; Myopic Choroidal Neovascularization

Read more: Lucentis (ranibizumab) FDA Approval History

Ilumya (tildrakizumab-asmn) Injection

Date of Approval: March 20, 2018
Company: Sun Pharmaceutical Industries Ltd.
Treatment for: Plaque Psoriasis

Ilumya (tildrakizumab-asmn) is a humanized, anti-IL-23p19 monoclonal antibody for the treatment of moderate-to-severe plaque psoriasis.

Read more: Ilumya (tildrakizumab-asmn) FDA Approval History

Symfi (efavirenz, lamivudine and tenofovir disoproxil fumarate) Tablets

Date of Approval: March 22, 2018
Company: Mylan N.V.
Treatment for: HIV Infection

Symfi (efavirenz, lamivudine and tenofovir disoproxil fumarate) is a three-drug combination of a non-nucleoside reverse transcriptase inhibitor (efavirenz), and two nucleo(t)side reverse transcriptase inhibitors (lamivudine and tenofovir disoproxil fumarate) indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection.

Read more: Symfi (efavirenz, lamivudine and tenofovir disoproxil fumarate) FDA Approval History

New Drug Approvals Archive