New Drug Approvals Archive - 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.

• Medicis Announces FDA Approval of Perlane
• Perlane (dermal filler) FDA Approval History

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.

• Indevus Announces FDA Approval of Supprelin-LA
• Supprelin-LA (histrelin acetate) FDA Approval History

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.

• FDA Approves Schwarz Pharma's Neupro (Rotigotine TransdermalSystem) for the Treatment of Early-Stage Parkinson's Disease in USA
• Neupro (rotigotine) FDA Approval History

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).

• FDA Approves Dey, L.P.'s Perforomist (Formoterol Fumarate) Inhalation Solution for Maintenance Treatment of COPD
• Perforomist (formoterol fumarate) FDA Approval History

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.

• FDA Approves Astrazeneca's Once-Daily Seroquel XR Extended-ReleaseTablets for the Treatment of Schizophrenia
• Seroquel XR (quetiapine) FDA Approval History

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.

• FDA Approves Lybrel, First Low Dose Combination Oral ContraceptiveOffering Women the Opportunity to Be Period-Free Over Time
• Lybrel (levonorgestrel and ethinyl estradiol) FDA Approval History

Tindamax (tinidazole)

New Indication Approved: May 21, 2007

• FDA Approves Tindamax for Bacterial Vaginosis
• Tindamax (tinidazole) FDA Approval History

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.

• FDA Approves Xyzal (Levocetirizine Dihydrochloride) Tablets for theRelief of Seasonal and Year Round Allergies, and Chronic Hives
• Xyzal (levocetirizine dihydrochloride) FDA Approval History

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.

• FDA Approves Torisel, a Targeted First-in-Class mTOR Inhibitor forthe Treatment of Advanced Kidney Cancer
• Torisel (temsirolimus) FDA Approval History

Seroquel XR (quetiapine)

New Indication Approved: November 15, 2007

• Seroquel XR Receives Approval From FDA for Maintenance Treatment ofSchizophrenia
• Seroquel XR (quetiapine) FDA Approval History

Xyzal (levocetirizine dihydrochloride)

New Dosage Form Approved: January 28, 2008

• FDA Approves Xyzal (levocetirizine dihydrochloride) Oral Solutionfor the Relief of Seasonal and Year Round Allergies and ChronicIdiopathic Urticaria
• Xyzal (levocetirizine dihydrochloride) FDA Approval History

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

Xyzal (levocetirizine dihydrochloride)

Patient Population Altered: August 21, 2009

• FDA Approves Xyzal For Use In Children Age Six Months And Older For The Relief Of Perennial Allergic Rhinitis And Chronic Idiopathic Urticaria
• Xyzal (levocetirizine dihydrochloride) FDA Approval History

Seroquel XR (quetiapine)

New Indication Approved: December 2, 2009

• FDA Approves Seroquel XR For Add-On Treatment of Major Depressive Disorder
• Seroquel XR (quetiapine) FDA Approval History

Neupro (rotigotine)

New Indication Approved: April 2, 2012

• Neupro Approved by U.S. FDA for Parkinson's Disease and Restless Legs Syndrome
• Neupro (rotigotine) FDA Approval History

Xyzal (levocetirizine dihydrochloride)

New Dosage Form Approved: January 31, 2017

• Sanofi's Xyzal Allergy 24HR Approved for Over-the-Counter Use
• Xyzal (levocetirizine dihydrochloride) FDA Approval History