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

Carnexiv (carbamazepine) FDA Approval History

Flublok (influenza vaccine)

New Formulation Approved: October 7, 2016

• FDA Approves Flublok Quadrivalent Influenza Vaccine

Flublok (influenza vaccine) FDA Approval History

Lucentis (ranibizumab)

New Dosage Form Approved: October 13, 2016
Treatment for: Macular Degeneration; Macular Edema; Diabetic Macular Edema; Diabetic Retinopathy; Myopic Choroidal Neovascularization

• FDA Approves Genentech’s Lucentis (ranibizumab) Prefilled Syringe

Lucentis (ranibizumab) FDA Approval History

Tecentriq (atezolizumab)

New Indication Approved: October 18, 2016

• FDA Approves Genentech’s Cancer Immunotherapy Tecentriq (Atezolizumab) for People with a Specific Type of Metastatic Lung Cancer

Tecentriq (atezolizumab) FDA Approval History

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).

• FDA Grants Accelerated Approval to Lartruvo (olaratumab) for Advanced Soft Tissue Sarcoma

Lartruvo (olaratumab) FDA Approval History

Vermox (mebendazole)

New Formulation Approved: October 19, 2016

• U.S. FDA Approves Vermox Chewable (Mebendazole) for Treatment of Children and Adults with Roundworm and Whipworm Infections

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

Zinplava (bezlotoxumab) FDA Approval History

Keytruda (pembrolizumab)

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

Keytruda (pembrolizumab) FDA Approval History