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New Drug Approvals Archive

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June 2012

June 7

Horizant (gabapentin enacarbil)

New Indication Approved: June 6, 2012

Horizant (gabapentin enacarbil) FDA Approval History

June 8

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 combination treatment of HER2-positive metastatic breast cancer, and for the neoadjuvant treatment of breast cancer.

Perjeta (pertuzumab) FDA Approval History

June 14

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).

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

June 21

Lyrica (pregabalin)

New Indication Approved: June 20, 2012

Lyrica (pregabalin) FDA Approval History

June 26

Gammagard Liquid (immune globulin infusion (human))

New Indication Approved: June 25, 2012

Gammagard Liquid (immune globulin infusion (human)) FDA Approval History

June 27

Belviq (lorcaserin) Tablets - formerly Lorqess

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.

Belviq (lorcaserin) FDA Approval History

June 28

Myrbetriq (mirabegron) Extended Release Tablets

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

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.

Myrbetriq (mirabegron) FDA Approval History

September 30

Perjeta (pertuzumab)

New Indication Approved: September 30, 2013

Perjeta (pertuzumab) FDA Approval History

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