New Drug Approvals Archive - June 2008

Reclast (zoledronic acid)

New Indication Approved: June 3, 2008

• FDA broadens US indication for once-yearly Reclast as only osteoporosis treatment approved for prevention of fractures after a hip fracture

Reclast (zoledronic acid) FDA Approval History

Requip (ropinirole)

New Dosage Form Approved: July 1, 2008

• U.S. FDA Approves Requip XL, the First and Only Oral Once-Daily Non-Ergot Dopamine Agonist for Parkinson's Disease

Cymbalta (duloxetine)

New Indication Approved: June 13, 2008

• FDA Approves Cymbalta for the Management of Fibromyalgia

Cymbalta (duloxetine) FDA Approval History

Trivaris (triamcinolone acetonide) Intravitreal Injection

Date of Approval: June 16, 2008
Company: Allergan, Inc.
Treatment for: Ocular Inflammatory Conditions

Trivaris (triamcinolone acetonide) is a glucocorticoid corticosteroid delivered via intravitreal injection for the treatment of sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids.

• Allergan Receives U.S. Food and Drug Administration Approval for Trivaris (triamcinolone acetonide injectable suspension) 80 mg/mL

Trivaris (triamcinolone acetonide) FDA Approval History

Avodart (dutasteride)

New Indication Approved: June 19, 2008

• FDA Approves GlaxoSmithKline's Avodart in Combination withTamsulosin for the Treatment of Symptomatic Enlarged Prostate

Velcade (bortezomib)

New Indication Approved: June 20, 2008

• FDA Approves Velcade (Bortezomib) for Injection for Patients with Previously Untreated Multiple Myeloma

Pentacel (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine)

Date of Approval: June 20, 2008
Company: Sanofi pasteur
Treatment for: Diphtheria Prophylaxis, Tetanus Prophylaxis, Pertussis Prophylaxis, Poliomyelitis Prophylaxis, Haemophilus influenzae Prophylaxis

Pentacel is a combination vaccine indicated for active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive disease due to Haemophilus influenzae type b in children 6 weeks through 4 years of age.

• U.S. FDA Licenses Sanofi Pasteur's New Pediatric CombinationVaccine, Pentacel

Pentacel (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine) FDA Approval History

PrandiMet (repaglinide and metformin) Tablets

Date of Approval: June 23, 2008
Company: Sciele Pharma, Inc. and Novo Nordisk Inc.
Treatment for: Diabetes Type 2

PrandiMet (repaglinide and metformin HCl) is a fixed-dose combination of the fast-acting secretagogue replaglinide (also known as Prandin) and insulin sensitizer, metformin, indicated for the treatment of type 2 diabetes.

• FDA Approves PrandiMet, a Replaglinide and Metformin Fixed-Dose Combination Tablet for Treatment of Type 2 Diabetes

PrandiMet (repaglinide and metformin) FDA Approval History

Durezol (difluprednate) Ophthalmic Emulsion

Date of Approval: June 23, 2008
Company: Sirion Therapeutics, Inc.
Treatment for: Postoperative Ocular Inflammation

Durezol (difluprednate ophthalmic emulsion) is a topical steroid for the treatment of postoperative ocular inflammation and pain.

• Sirion Therapeutics Announces FDA Approval of Durezol for Treatmentof Postoperative Ocular Inflammation and Pain

Durezol (difluprednate) FDA Approval History

Aptivus (tipranavir)

New Dosage Form Approved: June 23, 2008

• New Aptivus (tipranavir) Oral Solution Approved forTreatment-Experienced Pediatric and Adolescent HIV Patients

Aptivus (tipranavir) FDA Approval History

Kinrix (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine)

Date of Approval: June 24, 2008
Company: GlaxoSmithKline
Treatment for: Diphtheria Prophylaxis, Tetanus Prophylaxis, Poliomyelitis Prophylaxis, Pertussis Prophylaxis

Kinrix [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine] is a combination vaccine for protection against diphtheria, tetanus, pertussis and polio diseases in children.

• FDA Approves Kinrix - New Combination Vaccine for Children

Kinrix (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine) FDA Approval History

Concerta (methylphenidate)

Patient Population Altered: June 27, 2008

• FDA Approves Concerta (methylphenidate HCl) Extended-release Tablets for Treatment of ADHD (Attention Deficit Hyperactivity Disorder) in Adults

Metvixia (methyl aminolevulinate hydrochloride)

New Formulation Approved: June 26, 2008

• Photocure Receives FDA Approval for Metvixia/Aktilite Photodynamic Therapy

Metvixia (methyl aminolevulinate hydrochloride) FDA Approval History

Evolence (dermal filler)

Date of Approval: June 27, 2008
Company: OrthoNeutrogena
Treatment for: Facial Wrinkles

Evolence is a collagen-based structural dermal filler for the correction of moderate to deep facial wrinkles and folds, such as nasolabial folds.

• FDA Approves Evolence, a New Generation Collagen-Based Facial Filler

Evolence (dermal filler) FDA Approval History

Evolence (dermal filler)

Labeling Revision Approved: June 8, 2009
Treatment for: Facial Wrinkles

• FDA Approves 12-Month Labeling Update for Evolence Collagen-Based Facial Filler

Evolence (dermal filler) FDA Approval History