Rx Product News (September 2015)

Galderma Laboratories

Indication: The FDA has approved Epiduo Forte Gel, an antibiotic-free adapalene and benzoyl peroxide 0.3%/2.5% gel for the once-daily treatment of acne vulgaris. As an antibiotic-free acne treatment that was well tolerated in clinical trials, Epiduo Forte Gel can be considered for long-term use and offers convenience in a pump with once-daily dosing.

Dosage Form: Gel: adapalene 0.3%/ benzoyl peroxide 2.5%

For More Information: www.galdermausa.com

PraluentMarketed by: Sanofi US and Regeneron Pharmaceuticals

Indication: The FDA has approved Praluent (alirocumab), a proprotein convertase subtilisin kexin type 9 inhibitor antibody, as adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease, who require additional lowering of low-density lipoprotein cholesterol (LDL-C). The recommended starting dose for Praluent is 75 mg subcutaneously once every 2 weeks. If the LDL-C response is inadequate, the dosage may be increased to the maximum dosage of 150 mg every 2 weeks.

Dosage Form: Injection: 75 mg/mL or 150 mg/mL solution in a single-dose prefilled pen or syringe

For More Information: www.praluent.com

RapamuneMarketed by: Pfizer

Indication: The FDA has approved Rapamune (sirolimus) for the treatment of patients with lymphangioleiomyomatosis. The recommended dosage is once daily by mouth, consistently with or without food. The initial dose should be 2 mg/day and adjusted to achieve sirolimus trough concentrations between 5 and 15 ng/mL.

Dosage Form: Oral solution: 60 mg/60 mL in an amber glass bottle Tablets: 0.5 mg, tan; 1 mg, white; 2 mg, yellow-to-beige

For More Information: www.pfizer.com/products/productdetail/ rapamune

Finacea FoamMarketed by: Bayer HealthCare

Indication: The FDA has approved Finacea Foam (azelaic acid) for the topical treatment of inflammatory papules and pustules of mild to moderate rosacea. A thin layer of Finacea Foam should be applied twice daily (morning and evening) to the entire facial area (cheeks, chin, forehead, and nose). Cosmetics may be applied after the application of Finacea Foam has dried. The product is not for oral, ophthalmic, or intravaginal use.

Dosage Form: Foam: 15%

For More Information: www.finaceafoam.com