New Drug Approvals Archive

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May 2009

May 1

Cetraxal (ciprofloxacin otic) Solution

Date of Approval: May 1, 2009
Company: Salvat
Treatment for: Otitis Externa

Cetraxal (ciprofloxacin otic) is an antibiotic ear solution for the treatment of acute otitis externa.

Cetraxal (ciprofloxacin otic) FDA Approval History

May 6

Avastin (bevacizumab)

New Indication Approved: May 5, 2009

Avastin (bevacizumab) FDA Approval History

May 5

Cycloset (bromocriptine mesylate) Tablets

Date of Approval: May 5, 2009
Company: VeroScience and S2 Therapeutics, Inc.
Treatment for: Diabetes Type 2

Cycloset (bromocriptine) is a first-in-class, central acting agent for the treatment of Type 2 Diabetes.

Cycloset (bromocriptine mesylate) FDA Approval History

May 6

Fanapt (iloperidone) Tablets

Date of Approval: May 6, 2009
Company: Vanda Pharmaceuticals Inc.
Treatment for: Schizophrenia

Fanapt (iloperidone) is a 5HT2/D2 antagonist (atypical) antipsychotic for the treatment of schizophrenia.

Fanapt (iloperidone) FDA Approval History

May 11

Lamictal (lamotrigine)

New Dosage Form Approved: May 8, 2009

May 13

Azor (amlodipine and olmesartan)

New Indication Approved: May 11, 2009

Azor (amlodipine and olmesartan) FDA Approval History

May 13

ACTOplus met (pioglitazone and metformin)

New Dosage Form Approved: May 12, 2009

ACTOplus met (pioglitazone and metformin) FDA Approval History

May 13

Cimzia (certolizumab pegol)

New Indication Approved: May 13, 2009

Cimzia (certolizumab pegol) FDA Approval History

May 14

Prevacid (lansoprazole)

New Dosage Form Approved: May 13, 2009

May 18

Risperdal (risperidone)

New Indication Approved: May 15, 2009

May 19

Samsca (tolvaptan) Tablets

Date of Approval: May 19, 2009
Company: Otsuka Pharmaceutical Development & Commercialization, Inc.
Treatment for: Hyponatremia

Samsca (tolvaptan) is an oral selective vasopressin antagonist for the treatment of patients with clinically significant hypervolemic and euvolemic hyponatremia.

Samsca (tolvaptan) FDA Approval History

May 22

Adcirca (tadalafil) Tablets

Date of Approval: May 22, 2009
Company: United Therapeutics Corporation
Treatment for: Pulmonary Hypertension

Adcirca (tadalafil) is a once-daily phosphodiesterase type 5 (PDE5) inhibitor for the treatment of pulmonary arterial hypertension (PAH).

Adcirca (tadalafil) FDA Approval History

May 26

Sprycel (dasatinib)

Labeling Revision Approved: May 21, 2009

Sprycel (dasatinib) FDA Approval History

May 28

Prograf (tacrolimus)

Labeling Revision Approved: May 19, 2009

May 28

Besivance (besifloxacin) Ophthalmic Suspension

Date of Approval: May 28, 2009
Company: Bausch & Lomb
Treatment for: Bacterial Conjunctivitis

Besivance (besifloxacin ophthalmic suspension) is a topical quinolone antimicrobial for the treatment of bacterial conjunctivitis, commonly referred to as "pink eye."

Besivance (besifloxacin) FDA Approval History

February 5

Lamictal XR (lamotrigine)

New Indication Approved: January 29, 2010

Lamictal XR (lamotrigine) FDA Approval History

April 26

Lamictal XR (lamotrigine)

Labeling Revision Approved: April 25, 2011

Lamictal XR (lamotrigine) FDA Approval History

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