New Drug Approvals Archive - June 2012
Horizant (gabapentin enacarbil)
New Indication Approved: June 6, 2012
Perjeta (pertuzumab) Injection
Date of Approval: June 8, 2012
Perjeta (pertuzumab) is a humanized monoclonal antibody indicated for the combination treatment of HER2-positive metastatic breast cancer, and for the neoadjuvant treatment of breast cancer.
MenHibrix (Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine)
Date of Approval: June 14, 2012
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).
New Indication Approved: June 20, 2012
Gammagard Liquid (immune globulin infusion (human))
New Indication Approved: June 25, 2012
Belviq (lorcaserin) Tablets - formerly Lorqess
Date of Approval: June 27, 2012
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
Date of Approval: June 28, 2012
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.
New Indication Approved: September 30, 2013
New Formulation Approved: July 15, 2016