New Drug Approvals Archive

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May 2007

May 2

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.

Perlane (dermal filler) FDA Approval History

May 3

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.

Supprelin-LA (histrelin acetate) FDA Approval History

May 9

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.

Neupro (rotigotine) FDA Approval History

May 11

Perforomist (formoterol fumarate) Inhalation Solution

Date of Approval: May 11, 2007
Company: Dey, L.P.
Treatment for: Chronic Obstructive Pulmonary Disease

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).

Perforomist (formoterol fumarate) FDA Approval History

May 17

Seroquel XR (quetiapine) Tablets

Date of Approval: May 17, 2007
Company: AstraZeneca
Treatment for: Bipolar Disorder, Schizophrenia, 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.

Seroquel XR (quetiapine) FDA Approval History

May 22

Lybrel (levonorgestrel and ethinyl estradiol) Low Dose Continuous Regimen

Date of Approval: May 22, 2007
Company: Wyeth Pharmaceuticals Inc.
Treatment for: Contraception

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.

Lybrel (levonorgestrel and ethinyl estradiol) FDA Approval History

May 24

Tindamax (tinidazole)

New Indication Approved: May 21, 2007

Tindamax (tinidazole) FDA Approval History

May 25

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.

Xyzal (levocetirizine dihydrochloride) FDA Approval History

May 30

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.

Torisel (temsirolimus) FDA Approval History

November 16

Seroquel XR (quetiapine)

New Indication Approved: November 15, 2007

Seroquel XR (quetiapine) FDA Approval History

February 19

Xyzal (levocetirizine dihydrochloride)

New Dosage Form Approved: January 28, 2008

Xyzal (levocetirizine dihydrochloride) FDA Approval History

October 10

Seroquel XR (quetiapine)

New Indication Approved: October 8, 2008

Seroquel XR (quetiapine) FDA Approval History

August 25

Xyzal (levocetirizine dihydrochloride)

Patient Population Altered: August 21, 2009

Xyzal (levocetirizine dihydrochloride) FDA Approval History

December 4

Seroquel XR (quetiapine)

New Indication Approved: December 2, 2009

Seroquel XR (quetiapine) FDA Approval History

April 3

Neupro (rotigotine)

New Indication Approved: April 2, 2012

Neupro (rotigotine) FDA Approval History

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