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

• 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