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New Drug Approvals Archive - March 2013

See also: New Indications and Dosage Forms for March 2013

March 2013

Lymphoseek (technetium Tc 99m tilmanocept) Injection

Date of Approval: March 13, 2013
Company: Navidea Biopharmaceuticals
Treatment for: Diagnostic

Lymphoseek (technetium Tc 99m tilmanocept) Injection is a radioactive diagnostic agent indicated for lymphatic mapping in patients with breast cancer or melanoma, and for guiding sentinel lymph node biopsy in patients with squamous cell carcinoma of the oral cavity.

Dotarem (gadoterate meglumine) Injection

Date of Approval: March 20, 2013
Company: Guerbet
Treatment for: Diagnostic

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

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.

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.

Invokana (canagliflozin) Tablets

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

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.

Quartette (levonorgestrel/ethinyl estradiol and ethinyl estradiol) Tablets

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

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

Karbinal ER (carbinoxamine) Extended-Release Oral Suspension

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

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