New Drug Approvals Archive - October 2016
Carnexiv (carbamazepine) Injection
Date of Approval: October 7, 2016
Company: Lundbeck Inc.
Treatment for: Seizures
Carnexiv (carbamazepine) is an intravenous injection formulation of the antiepileptic drug carbamazepine indicated as short-term replacement therapy for oral carbamazepine when oral administration is temporarily not feasible.
- FDA Approves Carnexiv (carbamazepine) injection as Intravenous Short-Term Replacement Therapy for Certain Seizure Types
Flublok (influenza vaccine)
New Formulation Approved: October 7, 2016
New Dosage Form Approved: October 13, 2016
Treatment for: Macular Degeneration; Macular Edema; Diabetic Macular Edema; Diabetic Retinopathy; Myopic Choroidal Neovascularization
Read more: Lucentis (ranibizumab) FDA Approval History
New Indication Approved: October 18, 2016
- FDA Approves Genentech’s Cancer Immunotherapy Tecentriq (Atezolizumab) for People with a Specific Type of Metastatic Lung Cancer
Lartruvo (olaratumab) Injection
Date of Approval: October 19, 2016
Company: Eli Lilly and Company
Treatment for: Soft Tissue Sarcoma
Lartruvo (olaratumab) is a platelet-derived growth factor receptor alpha (PDGFR-α) blocking antibody indicated in combination with doxorubicin for the treatment of patients with advanced soft tissue sarcoma (STS).
Read more: Lartruvo (olaratumab) FDA Approval History
New Formulation Approved: October 19, 2016
Zinplava (bezlotoxumab) Injection
Date of Approval: October 21, 2016
Company: Merck & Co., Inc.
Treatment for: Prevention of Clostridium Difficile Infection Recurrence
Zinplava (bezlotoxumab) is a selective, fully-human, monoclonal antibody that binds to Clostridium difficile toxin B, indicated to reduce recurrence of Clostridium difficile infection (CDI) in patients 18 years of age or older.
- FDA Approves Merck’s Zinplava (bezlotoxumab) to Reduce Recurrence of Clostridium difficile Infection
Read more: Zinplava (bezlotoxumab) FDA Approval History
New Indication Approved: October 24, 2016
- FDA Approves Merck’s Keytruda (pembrolizumab) for First-Line Treatment of Certain Patients with Metastatic Non-Small Cell Lung Cancer