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New Drug Approvals Archive - October 2008

October 2008

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.

Read more: 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.

Read more: Rapaflo (silodosin) 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).

Read more: 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.

Read more: 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.

Read more: Acanya (benzoyl peroxide and clindamycin phosphate) 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.

Read more: LoSeasonique (ethinyl estradiol and levonorgestrel) 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.

Read more: 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.

Read more: 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.

Read more: Apriso (mesalamine) FDA Approval History

New Drug Approvals Archive