New Drug Approvals Archive

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June 2008

June 5

Reclast (zoledronic acid)

New Indication Approved: June 3, 2008

Reclast (zoledronic acid) FDA Approval History

June 16

Requip (ropinirole)

New Dosage Form Approved: July 1, 2008

June 16

Cymbalta (duloxetine)

New Indication Approved: June 13, 2008

Cymbalta (duloxetine) FDA Approval History

June 16

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.

Trivaris (triamcinolone acetonide) FDA Approval History

June 20

Avodart (dutasteride)

New Indication Approved: June 19, 2008

June 23

Velcade (bortezomib)

New Indication Approved: June 20, 2008

June 20

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.

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

June 23

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.

PrandiMet (repaglinide and metformin) FDA Approval History

June 23

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.

Durezol (difluprednate) FDA Approval History

June 24

Aptivus (tipranavir)

New Dosage Form Approved: June 23, 2008

Aptivus (tipranavir) FDA Approval History

June 24

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.

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

June 27

Concerta (methylphenidate)

Patient Population Altered: June 27, 2008

June 27

Metvixia (methyl aminolevulinate hydrochloride)

New Formulation Approved: June 26, 2008

Metvixia (methyl aminolevulinate hydrochloride) FDA Approval History

June 27

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.

Evolence (dermal filler) FDA Approval History

June 10

Evolence (dermal filler)

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

Evolence (dermal filler) FDA Approval History

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