New Drug Approvals Archive - May 2007
See also: New Indications and Dosage Forms for May 2007
May 2007
Perlane (dermal filler)
Date of Approval: May 2, 2007
Company: Medicis
Treatment for: Facial Wrinkles
Perlane is a dermal filler for the correction of moderate to severe facial folds and wrinkles, such as nasolabial folds.
Supprelin-LA (histrelin acetate) Subcutaneous Implant
Date of Approval: May 3, 2007
Company: Indevus Pharmaceuticals, Inc.
Treatment for: Precocious Puberty
Supprelin-LA is a once-yearly implant of the gonadotropin releasing hormone (GnRH) analog histrelin, indicated for the treatment of central precocious puberty (CPP), the premature onset of puberty in children.
Neupro (rotigotine) Transdermal System
Date of Approval: May 9, 2007
Company: Schwarz Pharma
Treatment for: Parkinson's Disease, Restless Legs Syndrome
Neupro (rotigotine) is a dopamine agonist transdermal system indicated for the treatment of Parkinson’s disease and Restless Legs Syndrome.
Perforomist (formoterol fumarate) Inhalation Solution
Date of Approval: May 11, 2007
Company: Dey, L.P.
Treatment for: COPD
Perforomist is an inhalation solution formulation of the long-acting beta(2)-adrenergic agonist formoterol fumarate, indicated for the long-term, twice-daily maintenance treatment of bronchoconstriction for emphysema and chronic bronchitis, also known as Chronic Obstructive Pulmonary Disease (COPD).
Seroquel XR (quetiapine) Tablets
Date of Approval: May 17, 2007
Company: AstraZeneca
Treatment for: Schizophrenia, Bipolar Disorder, Depression
Seroquel XR (quetiapine) is an atypical antipsychotic agent indicated for the acute and maintenance treatment of schizophrenia, bipolar disorder and as an adjunctive treatment to antidepressants in adults with Major Depressive Disorder.
Lybrel (levonorgestrel and ethinyl estradiol) Tablets
Date of Approval: May 22, 2007
Company: Wyeth Pharmaceuticals Inc.
Treatment for: Birth Control
Marketing Status: Discontinued
Lybrel (levonorgestrel and ethinyl estradiol) is a low-dose combination contraceptive pill taken continuously (without a pill-free interval) and over time may eliminate scheduled menstrual periods. Lybrel is indicated for the prevention of pregnancy.
Xyzal (levocetirizine dihydrochloride)
Date of Approval: May 25, 2007
Company: UCB, Inc. and sanofi-aventis
Treatment for: Allergic Rhinitis, Allergic Urticaria
Xyzal (levocetirizine) is an antihistamine for the relief of symptoms associated with allergic rhinitis and urticaria.
Torisel (temsirolimus) Injection
Date of Approval: May 30, 2007
Company: Wyeth Pharmaceuticals, Inc.
Treatment for: Renal Cell Carcinoma
Torisel (temsirolimus), an inhibitor of mTOR kinase, is an antineoplastic agent indicated for the treatment of patients with advanced renal cell carcinoma.
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