New Drug Approvals Archive - August 2009

Avastin (bevacizumab)

New Indication Approved: July 31, 2009

• FDA Approves Avastin for the Most Common Type of Kidney Cancer

Avastin (bevacizumab) FDA Approval History

Livalo (pitavastatin) Tablets

Date of Approval: August 3, 2009
Company: Kowa Company, Ltd.
Treatment for: High Cholesterol

Livalo (pitavastatin) is an HMG CoA reductase inhibitor indicated for the primary treatment of hypercholesterolemia and combined dyslipidemia.

• FDA Approves Livalo for Primary Hypercholesterolemia and Combined Dyslipidemia

Livalo (pitavastatin) FDA Approval History

Invega (paliperidone)

New Indication Approved: July 31, 2009

• Invega Approved as the First and Only Treatment for Schizoaffective Disorder

Invega (paliperidone) FDA Approval History

Embeda (morphine sulfate and naltrexone hydrochloride) Extended Release Capsules

Date of Approval: August 13, 2009
Company: King Pharmaceuticals , Inc.
Treatment for: Pain

Embeda is an abuse-deterrent, extended-release morphine preparation for the treatment of chronic pain.

• FDA Approves Embeda For Management of Moderate to Severe Chronic Pain

Embeda (morphine sulfate and naltrexone hydrochloride) FDA Approval History

Saphris (asenapine) Sublingual Tablets

Date of Approval: August 13, 2009
Company: Allergan, Inc.
Treatment for: Schizophrenia, Bipolar Disorder

Saphris (asenapine) is an atypical antipsychotic for the treatment of schizophrenia and acute mania or mixed episodes associated with bipolar I disorder.

• Schering-Plough Announces FDA Approval of Saphris (asenapine)

Saphris (asenapine) FDA Approval History

Extavia (interferon beta-1b)

Date of Approval: August 14, 2009
Treatment for: Multiple Sclerosis

Extavia is a branded version of interferon beta-1b, a first-line disease-modifying therapy that has been a standard-of-care for multiple sclerosis for many years. Extavia is indicated for the treatment of MS patients with relapsing forms of the disease and for newly diagnosed patients.

• US FDA Approves Extavia - the First in a New Portfolio of Planned MS Therapies from Novartis to Help Patients with This Devastating Disease

Extavia (interferon beta-1b) FDA Approval History

Hiberix (Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)) Solution for Intramuscular Injection

Date of Approval: August 19, 2009
Company: GlaxoSmithKline
Treatment for: Haemophilus influenzae Prophylaxis

Hiberix is a vaccine indicated for active immunization as a booster dose for the prevention of invasive disease caused by Haemophilus influenzae type b. Hiberix is approved for use in children aged six weeks through four years of age (prior to fifth birthday).

• FDA Approves GSK's Hib Vaccine, Hiberix

Hiberix (Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)) FDA Approval History

Sabril (vigabatrin) Tablets and Oral Solution

Date of Approval: August 21, 2009
Company: Lundbeck Inc.
Treatment for: Epilepsy, Seizures

Sabril (vigabatrin) is an oral irreversible GABA-transaminase inhibitor for the treatment of Infantile Spasms and refractory complex partial seizures.

• Lundbeck Inc. Announces FDA Marketing Approval for Sabril for the Treatment of Two Difficult-to-Treat Epilepsies

Sabril (vigabatrin) FDA Approval History

Xyzal (levocetirizine dihydrochloride)

Patient Population Altered: August 21, 2009

• FDA Approves Xyzal For Use In Children Age Six Months And Older For The Relief Of Perennial Allergic Rhinitis And Chronic Idiopathic Urticaria

Xyzal (levocetirizine dihydrochloride) FDA Approval History

Zenpep (pancrelipase) Capsules - formerly Zentase

Date of Approval: August 27, 2009
Company: Allergan, Inc.
Treatment for: Pancreatic Exocrine Dysfunction

Zenpep (pancrelipase) is a combination of porcine-derived lipases, proteases, and amylases indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis, or other conditions.

• Eurand Granted FDA Approval for Zenpep

Zenpep (pancrelipase) FDA Approval History

Valcyte (valganciclovir)

New Dosage Form Approved: August 28, 2009

• FDA Approves Valcyte (valganciclovir hydrochloride) to Prevent Cytomegalovirus (CMV) Disease in Pediatric Patients Who Receive Heart or Kidney Transplants

Saphris (asenapine)

New Indication Approved: September 3, 2010

• Merck Receives Approval from FDA for Expanded Indications for Atypical Antipsychotic Medication Saphris (asenapine) Sublingual Tablets

Saphris (asenapine) FDA Approval History

Embeda (morphine sulfate and naltrexone hydrochloride)

Labeling Revision Approved: October 17, 2014

• FDA Approves Labeling with Abuse-Deterrent Features for Embeda (morphine/naltrexone)

Embeda (morphine sulfate and naltrexone hydrochloride) FDA Approval History

Saphris (asenapine)

Patient Population Altered: March 13, 2015

• Actavis Receives FDA Approval of Saphris for Pediatric Patients with Bipolar I Disorder

Saphris (asenapine) FDA Approval History

Hiberix (Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate))

Patient Population Altered: January 14, 2016

• FDA Approves Expanded Use of GSK Hib Vaccine From Booster Dose To Full Series

Hiberix (Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)) FDA Approval History