New Drug Approvals Archive - June 2011

Humalog (insulin lispro)

Labeling Revision Approved: May 18, 2011

• FDA Approves Updates to Lilly's Humalog (insulin lispro injection [rDNA origin]) Label

Potiga (ezogabine) Tablets

Date of Approval: June 10, 2011
Company: GlaxoSmithKline and Valeant Pharmaceuticals International
Treatment for: Seizures

Potiga (ezogabine) is a potassium channel opener indicated for the adjunctive treatment of adults with partial-onset seizures.

• Valeant and GlaxoSmithKline Announce U.S. FDA Approval of Potiga (ezogabine)

Potiga (ezogabine) FDA Approval History

Creon (pancrelipase)

New Dosage Form Approved: June 10, 2011

• Abbott Receives FDA Approval for Creon (pancrelipase) Infant-Specific Dosage for Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis

Creon (pancrelipase) FDA Approval History

Nulojix (belatacept) Injection

Date of Approval: June 15, 2011
Company: Bristol-Myers Squibb Company
Treatment for: Organ Transplant -- Rejection Prophylaxis

Nulojix (belatacept) is a selective T-cell costimulation blocker indicated for prophylaxis of organ rejection in adult patients receiving a kidney transplant.

• FDA Approves Nulojix for Kidney Transplant Patients

Nulojix (belatacept) FDA Approval History

Istodax (romidepsin)

New Indication Approved: June 16, 2011

• FDA Grants Accelerated Approval of Istodax As Treatment for Patients with Peripheral T-Cell Lymphoma Who Have Received at Least One Prior Therapy

Istodax (romidepsin) FDA Approval History

Oxecta (oxycodone) Tablets - formerly Acurox

Date of Approval: June 17, 2011
Company: Pfizer Inc. and Acura Pharmaceuticals Inc.
Treatment for: Pain

Oxecta (oxycodone hydrochloride) is an abuse-deterrent opioid analgesic formulation for the relief of moderate to severe pain.

• Pfizer and Acura Announce FDA Approval of Oxecta (Oxycodone HCl, USP) CII

Oxecta (oxycodone) FDA Approval History

Lupron Depot (leuprolide acetate)

New Dosage Regimen: June 17, 2011

• Abbott Receives FDA Approval for a New Six-Month Formulation of Lupron Depot (leuprolide acetate for depot suspension) for the Palliative Treatment of Advanced Prostate Cancer

Rectiv (nitroglycerin) Ointment - formerly Cellegesic

Date of Approval: June 21, 2011
Company: Allergan, Inc.
Treatment for: Anal Fissure and Fistula

Rectiv (nitroglycerin) is a topical ointment for the treatment of moderate to severe pain associated with chronic anal fissures.

• ProStrakan Receives FDA Approval for Rectiv for the Treatment of Moderate to Severe Pain Associated With Chronic Anal Fissures

Rectiv (nitroglycerin) FDA Approval History

LaViv (azficel-T)

Date of Approval: June 21, 2011
Company: Fibrocell Science, Inc.
Treatment for: Wrinkles

Azficel-T is an autologous cellular product indicated for improvement of the appearance of moderate to severe nasolabial fold wrinkles in adults.

• Fibrocell Science, Inc. Announces FDA Approval for laViv (azficel-T)

LaViv (azficel-T) FDA Approval History

Zutripro (chlorpheniramine, hydrocodone and pseudoephedrine) Oral Solution

Date of Approval: June 8, 2011
Company: Cypress Pharmaceutical, Inc.
Treatment for: Cough and Nasal Congestion

Zutripro (chlorpheniramine, hydrocodone and pseudoephedrine) Oral Solution is a combination product containing an antitussive, an antihistamine, and a nasal decongestant indicated for the relief of cough and nasal congestion associated with the common cold and upper respiratory allergies.

• FDA Approves Zutripro (hydrocodone bitartrate, chlorpheniramine maleate and pseudoephedrine HCl) Oral Solution

Zutripro (chlorpheniramine, hydrocodone and pseudoephedrine) FDA Approval History

Rezira (hydrocodone and pseudoephedrine) Oral Solution

Date of Approval: June 8, 2011
Company: Cypress Pharmaceutical, Inc.
Treatment for: Cough and Nasal Congestion

Rezira (hydrocodone and pseudoephedrine) Oral Solution is a combination product containing an antitussive and nasal decongestant indicated for the relief of cough and nasal congestion associated with the common cold.

• FDA Approves Rezira (hydrocodone bitartrate and pseudoephedrine HCl) Oral Solution

Rezira (hydrocodone and pseudoephedrine) FDA Approval History

Lazanda (fentanyl) Nasal Spray - formerly NasalFent

Date of Approval: June 30, 2011
Company: Archimedes Pharma
Treatment for: Pain

Lazanda (fentanyl) is an opioid analgesic nasal spray for the management of breakthrough pain in cancer patients.

• FDA Approves Lazanda - First Fentanyl Nasal Spray - for the Management of Breakthrough Pain in Cancer Patients

Lazanda (fentanyl) FDA Approval History