New Drug Approvals Archive - October 2008

Reyataz (atazanavir sulfate)

Patient Population Altered: September 30, 2008

• U.S. Food & Drug Administration Approved the use of Reyataz (atazanavir sulfate) Boosted with Ritonavir, in Combination Therapy, for Previously Untreated HIV-1 Infected Adult Patients

Akten (lidocaine hydrochloride) Ophthalmic Gel

Date of Approval: October 7, 2008
Company: Akorn, Inc.
Treatment for: Ocular Anesthesia

Akten (lidocaine hydrochloride) Ophthalmic Gel is a topical, ocular anesthetic formulation for use in ocular procedures that require a topical anesthetic agent.

• Akorn, Inc. Announces the FDA Approval of Akten Ophthalmic Gel 3.5%

Akten (lidocaine hydrochloride) FDA Approval History

Rapaflo (silodosin) Capsules

Date of Approval: October 8, 2008
Company: Allergan, Inc.
Treatment for: Benign Prostatic Hyperplasia

Rapaflo (silodosin) is an alpha(1)- adrenoreceptor antagonist for the treatment of the signs and symptoms associated with benign prostatic hyperplasia (BPH), or enlarged prostate.

• Watson Receives US FDA Approval for Rapaflo (silodosin) for the Treatment of Benign Prostatic Hyperplasia (BPH)

Rapaflo (silodosin) FDA Approval History

Risperdal (risperidone)

New Dosage Regimen: October 10, 2008

• FDA Approves New Injection Site for Risperdal Consta for Schizophrenia Treatment

Seroquel XR (quetiapine)

New Indication Approved: October 8, 2008

• FDA Approves AstraZeneca’s Seroquel XR for the Treatment of Bipolar Depression and Bipolar Mania in the US

Seroquel XR (quetiapine) FDA Approval History

Cinryze (C1 esterase inhibitor (Human))

Date of Approval: October 10, 2008
Company: Lev Pharmaceuticals, Inc.
Treatment for: Angioedema

Cinryze is a C1-esterase inhibitor indicated for routine prophylaxis against angioedema attacks in adolescent and adult patients with Hereditary Angioedema (HAE).

• Cinryze Receives FDA Approval for Prophylaxis Against Hereditary Angioedema Attacks

Cinryze (C1 esterase inhibitor (Human)) FDA Approval History

Astepro (azelastine) Nasal Spray

Date of Approval: October 15, 2008
Company: Meda AB
Treatment for: Allergic Rhinitis

Astepro (azelastine) is a nasal antihistamine for the treatment of seasonal allergic rhinitis.

• FDA Approves Astepro

Astepro (azelastine) FDA Approval History

Acanya (benzoyl peroxide and clindamycin phosphate) Topical Gel

Date of Approval: October 21, 2008
Company: Dow Pharmaceutical Sciences, Inc.
Treatment for: Acne

Acanya (benzoyl peroxide and clindamycin phosphate) is a topical antibacterial and antibiotic combination for the treatment of acne.

• FDA Approves Acanya

Acanya (benzoyl peroxide and clindamycin phosphate) FDA Approval History

Prezista (darunavir)

Patient Population Altered: October 21, 2008

• U.S. Food and Drug Administration (FDA) Approves Prezista Once-Daily as Part of Combination Therapy for Treatment-Naive Adults with HIV-1

Prezista (darunavir) FDA Approval History

Vaprisol (conivaptan hydrochloride)

New Formulation Approved: October 8, 2008

• FDA Approves Astellas' Vaprisol (Conivaptan Hydrochloride Injection) Premixed in 5% Dextrose for the Treatment of Hyponatremia

Vaprisol (conivaptan hydrochloride) FDA Approval History

LoSeasonique (ethinyl estradiol and levonorgestrel) Extended-Cycle Oral Contraceptive Tablets

Date of Approval: October 24, 2008
Company: Duramed Pharmaceuticals, Inc.
Treatment for: Contraception

LoSeasonique is a lower-dose, extended-cycle oral contraceptive indicated for the prevention of pregnancy.

• FDA Approves Duramed's LoSeasonique Oral Contraceptive

LoSeasonique (ethinyl estradiol and levonorgestrel) FDA Approval History

Apidra (insulin glulisine)

Patient Population Altered: October 24, 2008

• FDA Approves Rapid-Acting Insulin Apidra for Treatment of Children with Diabetes

Apidra (insulin glulisine) FDA Approval History

Vimpat (lacosamide) Tablets and Injection

Date of Approval: October 28, 2008
Company: UCB
Treatment for: Seizures

Vimpat (lacosamide) is an anti-convulsant drug for the treatment of partial onset seizures in adults with epilepsy.

• UCB's Vimpat Approved By U.S. FDA As Adjunctive Therapy for Partial Onset Seizures in Adults

Vimpat (lacosamide) FDA Approval History

Toviaz (fesoterodine fumarate) Extended Release Tablets

Date of Approval: October 31, 2008
Company: Pfizer Inc.
Treatment for: Urinary Frequency

Toviaz (fesoterodine fumarate) is a competitive muscarinic receptor antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.

• Pfizer's Toviaz (fesoterodine fumarate) Receives FDA Approval for the Treatment of Overactive Bladder

Toviaz (fesoterodine fumarate) FDA Approval History

Apriso (mesalamine) Extended-Release Capsules

Date of Approval: October 31, 2008
Company: Salix Pharmaceuticals, Ltd.
Treatment for: Ulcerative Colitis

Apriso (mesalamine) is a once-daily, locally-acting aminosalicylate indicated for the maintenance of remission of ulcerative colitis (UC) in adults.

• Apriso Granted FDA Marketing Approval for Maintenance of Remission of Ulcerative Colitis

Apriso (mesalamine) FDA Approval History

Astepro (azelastine)

New Formulation Approved: August 31, 2009

• Meda Receives FDA Approval of New Astepro (azelastine HCl) Nasal Spray 0.15%, the First and Only Once-Daily Nasal Antihistamine

Astepro (azelastine) FDA Approval History