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New Drug Approvals Archive - June 2012

See also: New Indications and Dosage Forms for June 2012

June 2012

Perjeta (pertuzumab) Injection

Date of Approval: June 8, 2012
Company: Genentech
Treatment for: Breast cancer

Perjeta (pertuzumab) is a humanized monoclonal antibody indicated for the treatment of HER2-positive breast cancer.

MenHibrix (Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine)

Date of Approval: June 14, 2012
Company: GlaxoSmithKline
Treatment for: Haemophilus influenzae Prophylaxis, Meningococcal Meningitis Prophylaxis

MenHibrix (Hib-MenCY-TT) is a combination vaccine for the active immunization of infants and young children 6 weeks through 18 months of age for the prevention of invasive diseases caused by Neisseria meningitidis serogroups C and Y and Haemophilus influenzae type b (Hib).

Belviq (lorcaserin) Tablets

Date of Approval: June 27, 2012
Company: Arena Pharmaceuticals, Inc.
Treatment for: Obesity

Belviq (lorcaserin) is a serotonin 2C receptor agonist indicated for chronic weight management in adults who are obese, or overweight and who have at least one weight-related condition such as high blood pressure, type 2 diabetes, or high cholesterol.

Myrbetriq (mirabegron) Extended Release Tablets and Granules

Date of Approval: June 28, 2012
Company: Astellas Pharma Inc.
Treatment for: Overactive Bladder; Neurogenic Detrusor Overactivity

Myrbetriq (mirabegron) is a beta-3 adrenergic agonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency, and neurogenic detrusor overactivity (NDO) in pediatric patients aged 3 years and older and weighing 35 kg or more.
Myrbetriq Granules is indicated for the treatment of NDO in pediatric patients aged 3 years and older.

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