New Drug Approvals Archive - June 2012

Horizant (gabapentin enacarbil)

New Indication Approved: June 6, 2012

• GSK and XenoPort Receive FDA Approval for Horizant for Postherpetic Neuralgia
• Horizant (gabapentin enacarbil) FDA Approval History

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.

• FDA Approves Perjeta (pertuzumab) for People With HER2-Positive Metastatic Breast Cancer
• Perjeta (pertuzumab) FDA Approval History

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).

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

Lyrica (pregabalin)

New Indication Approved: June 20, 2012

• FDA Approves Lyrica For The Management Of Neuropathic Pain Associated With Spinal Cord Injury Based On Priority Review
• Lyrica (pregabalin) FDA Approval History

Gammagard Liquid (immune globulin infusion (human))

New Indication Approved: June 25, 2012

• Baxter Announces FDA Approval for Gammagard Liquid as a Treatment for Multifocal Motor Neuropathy
• Gammagard Liquid (immune globulin infusion (human)) FDA Approval History

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.

• FDA Approves Belviq to Treat Some Overweight or Obese Adults
• Belviq (lorcaserin) FDA Approval History

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.

• FDA Approves Myrbetriq for Overactive Bladder
• Myrbetriq (mirabegron) FDA Approval History

Perjeta (pertuzumab)

New Indication Approved: September 30, 2013

• FDA Approves Perjeta for Neoadjuvant Breast Cancer Treatment
• Perjeta (pertuzumab) FDA Approval History

Belviq (lorcaserin)

New Formulation Approved: July 15, 2016

• Eisai Inc. and Arena Pharmaceuticals Announce FDA Approval of Belviq XR (lorcaserin HCl) Extended-Release Tablets
• Belviq (lorcaserin) FDA Approval History

Perjeta (pertuzumab)

New Indication Approved: December 20, 2017

• FDA Approves Genentech’s Perjeta (Pertuzumab) for Adjuvant Treatment of Specific Type of Early Breast Cancer
• Perjeta (pertuzumab) FDA Approval History

Myrbetriq (mirabegron)

New Indication Approved: April 27, 2018
Treatment for: Overactive Bladder

• FDA Approves Supplemental New Drug Application for Myrbetriq (mirabegron) for Use in Combination with Solifenacin Succinate for the Treatment of Overactive Bladder Symptoms
• Myrbetriq (mirabegron) FDA Approval History