New Drug Approvals Archive

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October 2008

October 2

Reyataz (atazanavir sulfate)

Patient Population Altered: September 30, 2008

October 7

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.

Akten (lidocaine hydrochloride) FDA Approval History

October 8

Rapaflo (silodosin) Capsules

Date of Approval: October 8, 2008
Company: Watson Pharmaceuticals, 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.

Rapaflo (silodosin) FDA Approval History

October 10

Risperdal (risperidone)

New Dosage Regimen: October 10, 2008

October 10

Seroquel XR (quetiapine)

New Indication Approved: October 8, 2008

Seroquel XR (quetiapine) FDA Approval History

October 10

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 (C1 esterase inhibitor (Human)) FDA Approval History

October 15

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.

Astepro (azelastine) FDA Approval History

October 21

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.

Acanya (benzoyl peroxide and clindamycin phosphate) FDA Approval History

October 22

Prezista (darunavir)

Patient Population Altered: October 21, 2008

Prezista (darunavir) FDA Approval History

October 22

Vaprisol (conivaptan hydrochloride)

New Formulation Approved: October 8, 2008

Vaprisol (conivaptan hydrochloride) FDA Approval History

October 24

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.

LoSeasonique (ethinyl estradiol and levonorgestrel) FDA Approval History

October 29

Apidra (insulin glulisine)

Patient Population Altered: October 24, 2008

Apidra (insulin glulisine) FDA Approval History

October 28

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.

Vimpat (lacosamide) FDA Approval History

October 31

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.

Toviaz (fesoterodine fumarate) FDA Approval History

October 31

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 (mesalamine) FDA Approval History

September 2

Astepro (azelastine)

New Formulation Approved: August 31, 2009

Astepro (azelastine) FDA Approval History

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