New Drug Approvals

The following drugs have recently been approved by the FDA. Includes newly approved drugs and new indications for drugs already approved.

See also: Generic Approvals, Approval Process, New Indications and Dosage forms

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Xiaflex (collagenase clostridium histolyticum)

Company: BioSpecifics Technologies Corp.

Date of Approval: February 3, 2010

Treatment for: Dupuytren's Contracture

Xiaflex (collagenase clostridium histolyticum) is a collagenase product for the treatment of Dupuytren's contracture, a condition that affects the connective tissue that lies beneath the skin in the palm.

Oleptro (trazodone) Extended Release Tablets - formerly DDS-04A

Company: Labopharm Inc.

Date of Approval: February 2, 2010

Treatment for: Depression

Oleptro (trazodone) is a once-daily serotonin antagonist reuptake inhibitor (SARI) formulation for the treatment of major depressive disorder (MDD) in adults.

Victoza (liraglutide) Injection

Company: Novo Nordisk A/S

Date of Approval: January 25, 2010

Treatment for: Diabetes Mellitus Type II

Victoza (liraglutide) is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Actemra (tocilizumab) Injection

Company: Genentech USA, Inc.

Date of Approval: January 8, 2010

Treatment for: Rheumatoid Arthritis

Actemra (tocilizumab) is a humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody for the treatment of moderate to severe rheumatoid arthritis in adults.

Zyprexa Relprevv (olanzapine) for Extended Release Injectable Suspension

Company: Lilly

Date of Approval: December 11, 2009

Treatment for: Schizophrenia

Zyprexa Relprevv (olanzapine) is a long-acting atypical antipsychotic for intramuscular injection indicated for the treatment of schizophrenia.

Wilate (von Willebrand Factor/Coagulation Factor VIII Complex (Human)) Injection

Company: Octapharma USA

Date of Approval: December 4, 2009

Treatment for: von Willebrand's Disease

Wilate is a von Willebrand Factor/Coagulation Factor VIII Complex (Human) indicated for the treatment of spontaneous and trauma-induced bleeding episodes in patients with severe von Willebrand disease (VWD).

Zegerid OTC (omeprazole and sodium bicarbonate) Capsules

Company: Merck & Co. and Santarus Inc.

Date of Approval: December 1, 2009

Treatment for: Heartburn

Zegerid OTC (omeprazole and sodium bicarbonate) is an over-the-counter version of the prescription heartburn drug Zegerid.

Agriflu (influenza virus vaccine, inactivated) Injection

Company: Novartis Vaccines and Diagnostics, Inc.

Date of Approval: November 27, 2009

Treatment for: Influenza Prophylaxis

Agriflu (influenza virus vaccine, inactivated) is a vaccine indicated for the active immunization of adults 18 years of age and older against influenza disease caused by influenza virus subtypes A and type B present in the vaccine.

Qutenza (capsaicin) Transdermal Patch - formerly NGX-4010

Company: NeurogesX, Inc.

Date of Approval: November 16, 2009

Treatment for: Postherpetic Neuralgia

Qutenza, formerly NGX-4010, is a capsaicin transdermal patch for the management of pain due to postherpetic neuralgia.

Lysteda (tranexamic acid) Tablets - formerly XP12B

Company: Xanodyne Pharmaceuticals, Inc.

Date of Approval: November 13, 2009

Treatment for: Menorrhagia

Lysteda (tranexamic acid) is an antifibrinolytic agent for the treatment of women with menorrhagia, heavy menstrual bleeding (HMB), and its accompanying symptoms.

Istodax (romidepsin) for Injection

Company: Gloucester Pharmaceuticals

Date of Approval: November 5, 2009

Treatment for: Cutaneous T-cell Lymphoma

Istodax (romidepsin) a histone deacetylase (HDAC) inhibitor indicated the treatment of cutaneous T-cell lymphoma.

Pennsaid (diclofenac sodium) Topical Solution

Company: Nuvo Research Inc.

Date of Approval: November 4, 2009

Treatment for: Osteoarthritis

Pennsaid is a topical non-steroidal anti-inflammatory drug (NSAID) used for the treatment of signs and symptoms of osteoarthritis of the knee.

Arzerra (ofatumumab) Injection

Company: GlaxoSmithKline

Date of Approval: October 26, 2009

Treatment for: Chronic Lymphocytic Leukemia

Arzerra (ofatumumab) is a CD20-directed cytolytic monoclonal antibody indicated for the treatment of patients with chronic lymphocytic leukemia.

Votrient (pazopanib) Tablets

Company: GlaxoSmithKline

Date of Approval: October 19, 2009

Treatment for: Renal Cell Carcinoma

Votrient (pazopanib) is a kinase inhibitor indicated for the treatment of patients with advanced renal cell carcinoma.

Twynsta (telmisartan and amlodipine) Tablets

Company: Boehringer Ingelheim Pharmaceuticals Inc.

Date of Approval: October 16, 2009

Treatment for: Hypertension

Twynsta (telmisartan/amlodipine) is an angiotensin II receptor blocker (ARB) and a dihydropyridine calcium channel blocker (DHP-CCB) combination product indicated for the treatment of hypertension alone or with other antihypertensive agents.

Cervarix (human papillomavirus bivalent (types 16 and 18) vaccine, recombinant) Injection

Company: GlaxoSmithKline

Date of Approval: October 16, 2009

Treatment for: Human Papillomavirus Prophylaxis

Cervarix (human papillomavirus bivalent (types 16 and 18) is a is a preventative cervical cancer vaccine for the prevention of cervical pre-cancers and cervical cancer associated with oncogenic human papillomavirus (HPV) types 16 and 18 in girls and young women (aged 10-25).

Berinert (C1 esterase inhibitor (human)) Injection

Company: CSL Behring

Date of Approval: October 9, 2009

Treatment for: Angioedema

Berinert (C1-esterase inhibitor (human)) is a plasma derived C1 Esterase Inhibitor indicated for the treatment of acute abdominal or facial attacks of hereditary angioedema (HAE) in adult and adolescent patients.

FDA Drug Approvals Archive

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