New Drug Approvals Archive

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August 2009

August 3

Invega (paliperidone)

New Dosage Form Approved: July 31, 2009

Invega (paliperidone) FDA Approval History

August 3

Avastin (bevacizumab)

New Indication Approved: July 31, 2009

Avastin (bevacizumab) FDA Approval History

August 3

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.

Livalo (pitavastatin) FDA Approval History

August 6

Invega (paliperidone)

New Indication Approved: July 31, 2009

Invega (paliperidone) FDA Approval History

August 13

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.

Embeda (morphine sulfate and naltrexone hydrochloride) FDA Approval History

August 13

Saphris (asenapine) Sublingual Tablets

Date of Approval: August 13, 2009
Company: Schering-Plough Corporation
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.

Saphris (asenapine) FDA Approval History

August 14

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.

Extavia (interferon beta-1b) FDA Approval History

August 19

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 15 months through 4 years of age (prior to fifth birthday).

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

August 21

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.

Sabril (vigabatrin) FDA Approval History

August 25

Xyzal (levocetirizine dihydrochloride)

Patient Population Altered: August 21, 2009

Xyzal (levocetirizine dihydrochloride) FDA Approval History

August 27

Zenpep (pancrelipase) Capsules - formerly Zentase

Date of Approval: August 27, 2009
Company: Eurand Pharmaceuticals Ltd.
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.

Zenpep (pancrelipase) FDA Approval History

August 31

Valcyte (valganciclovir)

New Dosage Form Approved: August 28, 2009

September 7

Saphris (asenapine)

New Indication Approved: September 3, 2010

Saphris (asenapine) FDA Approval History

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