New Drug Approvals Archive

Abilify (aripiprazole)

New Formulation Approved: February 28, 2013

• FDA Approves Once-Monthly Abilify Maintena (aripiprazole) for Extended-Release Injectable Suspension for the Treatment of Schizophrenia

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 with a hand-held gamma counter to assist in the localization of lymph nodes draining a primary tumor site in patients with 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: 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