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New Drug Approvals Archive - May 2009

See also: New Indications and Dosage Forms for May 2009

May 2009

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.

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.

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.

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.

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).

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."

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