New Drug Approvals Archive - December 2008

• Schering-Plough Announces FDA Approval of PegIntron and Rebetol Combination Therapy for Treating Pediatric Hepatitis C

Boostrix (tetanus, diphtheria, acellular pertussis vaccine (Tdap))

Patient Population Altered: December 4, 2008

• FDA Approves GlaxoSmithKline Tetanus, Diphtheria, Whooping Cough Vaccine, Boostrix, for Adults

Boostrix (tetanus, diphtheria, acellular pertussis vaccine (Tdap)) FDA Approval History

Lusedra (fospropofol disodium) Injection - formerly Aquavan

Date of Approval: December 12, 2008
Company: Eisai Corporation of North America
Treatment for: Sedation

Lusedra (fospropofol disodium) is an intravenous sedative-hypnotic agent for monitored anesthesia care (MAC) sedation in adult patients undergoing diagnostic or therapeutic procedures.

• FDA Approves Lusedra (fospropofol disodium) Injection for Monitored Anesthesia Care (MAC) Sedation

Lusedra (fospropofol disodium) FDA Approval History

Trilipix (fenofibric acid) Delayed-Release Capsules

Date of Approval: December 15, 2008
Company: Abbott
Treatment for: Hypertriglyceridemia, Hyperlipidemia

Trilipix (fenofibric acid) is a peroxisome proliferator receptor alpha (PPARα) activator indicated for use along with diet to help lower triglycerides and LDL cholesterol, and to raise HDL cholesterol in patients with lipid problems. Trilipix is the first and only fibrate to be approved for use in combination with a statin.

• Abbott Receives FDA Approval for Trilipix (fenofibric acid), First and Only Fibrate Indicated for Use in Combination With a Statin for Cholesterol Management

Trilipix (fenofibric acid) FDA Approval History

Mozobil (plerixafor)

Date of Approval: December 15, 2008
Company: Genzyme Corporation
Treatment for: Bone Marrow Transplantation

Mozobil (plerixafor) is a small molecule CXCR4 chemokine receptor antagonist used in combination with granulocyte-colony stimulating factor to mobilize hematopoietic stem cells to the bloodstream for collection and subsequent autologous transplantation in patients with non-Hodgkin’s lymphoma and multiple myeloma.

• FDA Approves Genzyme's Mozobil

Mozobil (plerixafor) FDA Approval History

BioThrax (Anthrax Vaccine Adsorbed)

New Dosage Regimen: December 11, 2008

• Emergent BioSolutions Receives FDA Approval for BioThrax Supplemental Biologics License Application

Oforta (fludarabine phosphate) Tablets - formerly Oral Fludarabine

Date of Approval: December 18, 2008
Company: sanofi-aventis U.S.
Treatment for: Chronic Lymphocytic Leukemia

Oforta (fludarabine phosphate) is an oral nucleoside analogue approved as a single agent for the treatment of adult patients with B-cell chronic lymphocytic leukemia (CLL).

• Antisoma Receives FDA Approval for Oral Fludarabine, Plans Commercialization Deal to Bring Drug to US Patients

Oforta (fludarabine phosphate) FDA Approval History

Acetadote (acetylcysteine)

Labeling Revision Approved: December 12, 2008

• Cumberland Pharmaceuticals Reports FDA Approval for Updated Labeling of Acetadote

Acetadote (acetylcysteine) FDA Approval History

Gleevec (imatinib mesylate)

New Indication Approved: December 19, 2008

• FDA Approves Gleevec to Prevent Recurrence of Rare Gastrointestinal Cancer

Zolpimist (zolpidem tartrate) Oral Spray

Date of Approval: December 19, 2008
Company: NovaDel Pharma, Inc.
Treatment for: Insomnia

Zolpimist is an oral spray formulation of zolpidem, the drug contained in Ambien. Zolpimist is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation.

• NovaDel Pharma Receives FDA Approval of Zolpimist

Zolpimist (zolpidem tartrate) FDA Approval History

Ablavar (gadofosveset trisodium) - formerly Vasovist

Date of Approval: December 22, 2008
Company: EPIX Pharmaceuticals, Inc.
Treatment for: Diagnostic

Ablavar - formerly Vasovist - (gadofosveset trisodium) is a blood pool magnetic resonance angiography (MRA) agent used to evaluate aortoiliac occlusive disease (AIOD) in adults with known or suspected peripheral vascular disease.

• EPIX Pharmaceuticals Announces FDA Approval of Vasovist (gadofosveset trisodium)

Ablavar (gadofosveset trisodium) FDA Approval History

Firmagon (degarelix) for Injection

Date of Approval: December 24, 2008
Company: Ferring Pharmaceuticals, USA
Treatment for: Prostate Cancer

Firmagon (degarelix) is an injectable gonadotropin-releasing hormone (GnRH) receptor antagonist indicated for patients with advanced prostate cancer.

• FDA Approves Ferring Pharmaceuticals' Degarelix for Treatment of Advanced Prostate Cancer

Firmagon (degarelix) FDA Approval History

Latisse (bimatoprost) Ophthalmic Solution

Date of Approval: December 24, 2008
Company: Allergan, Inc.
Treatment for: Hypotrichosis of Eyelashes

Latisse (bimatoprost ophthalmic) is a prostamide indicated for the treatment of hypotrichosis (or reduced amount of hair) of the eyelashes. Growth of the eyelashes is a well documented side effect of bimatoprost which is currently approved as Lumigan for the treatment of glaucoma.

• Allergan Announces U.S. Food and Drug Administration (FDA) Approval of Latisse -- First and Only Treatment Approved by the FDA for Hypotrichosis of Eyelashes

Latisse (bimatoprost) FDA Approval History

Ryzolt (tramadol) Extended Release Tablets

Date of Approval: December 30, 2008
Company: Labopharm Inc.
Treatment for: Pain

Ryzolt (tramadol extended release) is a once-daily analgesic indicated for the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time.

• Labopharm Announces FDA Approval of Once-Daily Ryzolt for Moderate to Moderately Severe Chronic Pain

Ryzolt (tramadol) FDA Approval History

Nexterone (amiodarone HCl) Injection

Date of Approval: December 24, 2008
Company: Prism Pharmaceuticals
Treatment for: Ventricular Fibrillation, Ventricular Tachycardia

Nexterone (amiodarone HCl) Injection is a cosolvent free formulation of the antiarrhythmic agent Amiodarone IV, originally marketed in the US by Wyeth as Cordarone Intravenous. Nexterone is indicated for the treatment and prophylaxis of frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia in patients refractory to other therapy.

• Prism Pharmaceuticals Receives FDA Approval of Nexterone for Life-Threatening Ventricular Fibrillation and Ventricular Tachycardia

Nexterone (amiodarone HCl) FDA Approval History

Epiduo (adapalene and benzoyl peroxide) Gel

Date of Approval: December 8, 2008
Company: Galderma Laboratories, L.P.
Treatment for: Acne

Epiduo (adapalene and benzoyl peroxide) Gel is a once-daily, topical retinoid and antimicrobial combination for the treatment of acne.

• Galderma Announces Availability Of Epiduo Gel, The First And Only Combination Treatment With A Retinoid And Benzoyl Peroxide To Treat Acne

Epiduo (adapalene and benzoyl peroxide) FDA Approval History

Nexterone (amiodarone HCl)

New Formulation Approved: November 16, 2010

• Prism Pharmaceuticals Receives FDA Approval of Ready-to-Use Nexterone (Amiodarone HCl) Premixed Injection

Nexterone (amiodarone HCl) FDA Approval History

Epiduo (adapalene and benzoyl peroxide)

Patient Population Altered: February 1, 2013

• Epiduo Gel Becomes First Topical Prescription Acne Treatment Available For Children As Young As 9 Years Old

Epiduo (adapalene and benzoyl peroxide) FDA Approval History