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)) Injection

Date of Approval: October 10, 2008
Company: Shire plc
Treatment for: Hereditary Angioedema

Cinryze is a C1-esterase inhibitor indicated for routine prophylaxis against angioedema attacks in 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

Cinryze (C1 esterase inhibitor (human))

Patient Population Altered: June 20, 2018

• Shire Announces FDA Approval for Label Expansion of Cinryze (C1 esterase inhibitor [human]) for Prevention of Attacks in Pediatric Hereditary Angioedema Patients
• Cinryze (C1 esterase inhibitor (human)) FDA Approval History