New Drug Approvals Archive

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March 2013

March 1

Abilify (aripiprazole)

New Formulation Approved: February 28, 2013

March 13

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.

Lymphoseek (technetium Tc 99m tilmanocept) FDA Approval History

March 20

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).

Dotarem (gadoterate meglumine) FDA Approval History

March 22

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.

TOBI Podhaler (tobramycin) FDA Approval History

March 26

Aciphex (rabeprazole)

New Formulation Approved: March 26, 2013

March 27

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.

Tecfidera (dimethyl fumarate) FDA Approval History

March 29

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.

Invokana (canagliflozin) FDA Approval History

March 28

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.

Quartette (levonorgestrel/ethinyl estradiol and ethinyl estradiol) FDA Approval History

March 28

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.

Karbinal ER (carbinoxamine) FDA Approval History

June 13

Lymphoseek (technetium Tc 99m tilmanocept)

New Indication Approved: June 13, 2014

Lymphoseek (technetium Tc 99m tilmanocept) FDA Approval History

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