New Drug Approvals Archive - March 2013

Lymphoseek (technetium Tc 99m tilmanocept) Injection

Date of Approval: March 13, 2013
Company: Navidea Biopharmaceuticals
Treatment for: Diagnosis and Investigation

Lymphoseek (technetium Tc 99m tilmanocept) Injection is a radioactive diagnostic agent indicated with or without scintigraphic imaging for:

• Lymphatic mapping using a handheld gamma counter to locate lymph nodes draining a primary tumor site in adult and pediatric patients age one month and older with solid tumors for which this procedure is a component of intraoperative management.
• Guiding sentinel lymph node biopsy using a handheld gamma counter in patients with clinically node negative squamous cell carcinoma of the oral cavity, breast cancer or melanoma.

• FDA Approves Lymphoseek to Help Locate Lymph Nodes in Patients with Certain Cancers
• Lymphoseek (technetium Tc 99m tilmanocept) FDA Approval History

Dotarem (gadoterate meglumine) Injection

Date of Approval: March 20, 2013
Company: Guerbet
Treatment for: Diagnosis and Investigation

Dotarem (gadoterate meglumine) is a gadolinium-based contrast agent indicated for use in magnetic resonance imaging (MRI).

• FDA Approves Dotarem, a New Magnetic Resonance Imaging Agent
• Dotarem (gadoterate meglumine) FDA Approval History

TOBI Podhaler (tobramycin) Inhalation Powder

Date of Approval: March 22, 2013
Company: Novartis Pharmaceuticals Corporation
Treatment for: Cystic Fibrosis

TOBI Podhaler (tobramycin inhalation powder) is an antibacterial aminoglycoside indicated for the management of cystic fibrosis patients with Pseudomonas aeruginosa.

• FDA Approves TOBI Podhaler to Treat a Type of Bacterial Lung Infection in Cystic Fibrosis Patients
• TOBI Podhaler (tobramycin) FDA Approval History

Tecfidera (dimethyl fumarate) Delayed-Release Capsules - formerly BG-12

Date of Approval: March 27, 2013
Company: Biogen Idec
Treatment for: Multiple Sclerosis

Tecfidera (dimethyl fumarate) is an oral Nrf2 pathway activator for the treatment of relapsing forms of multiple sclerosis.

• FDA Approves Tecfidera - a New Treatment for Multiple Sclerosis
• Tecfidera (dimethyl fumarate) FDA Approval History

Invokana (canagliflozin) Tablets

Date of Approval: March 29, 2013
Company: Janssen Research & Development, LLC
Treatment for: Diabetes, Type 2, Cardiovascular Risk Reduction, Diabetic Kidney Disease

Invokana (canagliflozin) is a selective sodium glucose co-transporter 2 (SGLT2) inhibitor indicated:

• along with diet and exercise to lower blood sugar (glucose) in adults with type 2 diabetes
• to reduce the risk of major cardiovascular events in adults with type 2 diabetes who have known cardiovascular disease
• to reduce the risk of end-stage kidney disease (ESKD), worsening of kidney function, cardiovascular death, and hospitalization for heart failure in adults with type 2 diabetes mellitus and diabetic kidney disease (nephropathy) with a certain amount of protein in the urine.

• FDA Approves Invokana to Treat Type 2 Diabetes
• Invokana (canagliflozin) FDA Approval History

Quartette (levonorgestrel/ethinyl estradiol and ethinyl estradiol) Tablets

Date of Approval: March 28, 2013
Company: Teva Branded Pharmaceutical Products R&D, Inc.
Treatment for: Birth Control

Quartette (levonorgestrel/ethinyl estradiol and ethinyl estradiol) is a 91-day extended regimen oral contraceptive indicated for the prevention of pregnancy.

• FDA Approves Quartette (levonorgestrel/ethinyl estradiol and ethinyl estradiol) Tablets for the Prevention of Pregnancy
• Quartette (levonorgestrel/ethinyl estradiol and ethinyl estradiol) FDA Approval History

Karbinal ER (carbinoxamine) Extended-Release Oral Suspension

Date of Approval: March 28, 2013
Company: Tris Pharma, Inc.
Treatment for: Conjunctivitis, Allergic, Allergic Reactions, Allergic Rhinitis, Allergic Urticaria

Karbinal ER (carbinoxamine maleate) extended-release oral suspension is an H1 receptor antagonist indicated for the symptomatic treatment of seasonal and perennial allergic rhinitis.

• FDA Approves Tris Pharma's New Drug Application for Karbinal ER
• Karbinal ER (carbinoxamine) FDA Approval History