New Drug Approvals Archive - 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.

• 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: Diagnostic

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

Aciphex (rabeprazole)

New Formulation Approved: March 26, 2013

• FDA Approves Aciphex Sprinkle (rabeprazole sodium) For Use in Children Ages 1 to 11

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

Invokana (canagliflozin) is a selective sodium glucose co-transporter 2 (SGLT2) inhibitor for the treatment of type 2 diabetes.

• 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: Contraception

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: 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.

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

Lymphoseek (technetium Tc 99m tilmanocept)

New Indication Approved: June 13, 2014

• FDA Approves Lymphoseek to Help Determine the Extent of Head and Neck Cancer in the Body
• Lymphoseek (technetium Tc 99m tilmanocept) FDA Approval History

Dotarem (gadoterate meglumine)

Patient Population Altered: August 25, 2017

• FDA Approves Guerbet's Dotarem (gadoterate meglumine) for Pediatric Patients Younger Than Two Years
• Dotarem (gadoterate meglumine) FDA Approval History