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Rx Product News
Marketed by: Amylin Pharmaceuticals, Inc (San Diego, CA)
Indication: The FDA approved Bydureon (exenatide extended-release for inject- able suspension), a glucagon-like peptide-1 receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Bydureon, the first once-weekly treatment for type 2 diabetes, is an extended-release form of exenatide that is administered subcutaneously once every 7 days at any time of day and without regard to meals. It must be adminis- tered immediately after suspension. Bydureon carries a boxed warning against the risk of thyroid C-cell tumors.
Dosage Form: Extended-release injectable suspension: 2 mg exenatide
For More Information: www.bydureon.com
Marketed by: Quinnova Pharmaceuticals, Inc (Jamison, PA)
Indication: Quinnova Pharmaceuticals announced the launch of Atrapro Dermal Spray with Preservatives and Atrapro Antipruritic Hydrogel. Atrapro Dermal Spray with Preservatives is indicated for the management via debridement of wounds such as stage I to IV pressure ulcers, partial and full thickness wounds, diabetic foot ulcers, post-surgical wounds, first- and second-degree burns, and grafted and donor sites. Atrapro Antipruritic Hydrogel is indicated to manage and relieve the pain, burning, and itching associated with various dermatoses, including radiation and atopic dermatitis.
Dosage Form: Dermal spray: 8-oz bottle; hydrogel: 4-oz tube
For More Information: www.quinnova.com/products/atrapro
Vitamedmd Plus Rx
Marketed by: TherapeuticsMD, Inc (Boca Raton, FL)
Indication: TherapeuticsMD announced the launch of vitaMedMD Plus Rx, a prescrip- tion prenatal vitamin for women who are planning a pregnancy, pregnant, or nursing.Each dose of vitaMedMD Plus Rx consists of 1 prenatal tablet and 1 softgel. The prenatal tablet contains 16 vitamins and minerals, including a proprietary blend of folate, cal- cium 150 mg, vitamin D3 600 IU, and iron 30 mg. Each softgel contains 300 mg of plant-based docosahexaenoic acid.
How Supplied: Single-dose combination packs of 1 prenatal vitamin tablet and 1 DHA softgel
For More Information: www.vitamedmdrx.com
Marketed by: Pfizer, Inc (New York, NY)
Indication: Pfizer announced the FDA approval of Inlyta (axitinib) tablets for the treatment of advanced renal cell carcinoma after failure of 1 prior systemic therapy. The starting dose of Inlyta, which is a kinase inhibitor, is 5 mg orally twice daily, after which dose adjustments can be made based on safety and toler- ability. Inlyta tablets can be administered approximately 12 hours apart with or without food, and should be swallowed whole with a glass of water.
Dosage Form: Tablets: 1 and 5 mg
For More Information: http://inlyta.com
Marketed by: Teva Respiratory, LLC, a subsidiary of Teva Pharmaceutical Industries Ltd (Horsham, PA)
Indication: Teva Respiratory announced the FDA approval of ProAir HFA (albuterol sul- fate) Inhalation Aerosol with a dose counter. ProAir HFA is indicated for patients 4 years and older for the treatment or prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm. The dose counter is designed to help patients and their caregivers track the number of doses remaining in the canister.
Dosage Form: Inhalation aerosol: 108 mcg albuterol sulfate per actuation
For More Information: www.proairhfa.com
Differin gel 0.3%
Marketed by: Galderma Laboratories, LP (Fort Worth, TX)
Indication: Galderma Laboratories received FDA approval for the first-ever pump dispenser for Differin (adapalene) Gel 0.3%. Differin Gel 0.3% is indicated for the topical treatment of acne vulgaris in patients 12 years and older. Patients using Differin Gel 0.3% should apply a thin layer of the product to the entire face and any other affected areas of the skin once daily in the evening after washing gently with non-medicated soap. Application to the areas around the eyes, lips, and mucous membranes should be avoided.
How Supplied: 45-g tube or pump dispenser
For More Information: www.differin.com
Marketed by: Genentech, a member of the Roche Group (South San Francisco, CA)
Indication: The FDA approved Erivedge (vismodegib) capsules, a hedgehog pathway inhibitor indicated for the treatment of adults with metastatic basal cell carcinoma (BCC) or locally advanced BCC that has recurred following surgery or occurs in patients who are not candidates for surgery or radiation. It is the first medication approved for advanced forms of BCC. The recommended dose is 150 mg orally once daily. Erivedge carries a boxed warning against embryo-fetal death and severe birth defects.
Dosage Form: Capsules: 150 mg
For More Information: www.erivedge.com
Marketed by: Millenium Pharmaceuticals, a wholly owned subsidiary of Takeda Pharmaceutical Company Ltd (Cambridge, MA)
Indication: The FDA has approved the supplemental new drug application for Velcade (bortezomib) to include subcutaneous administration for all previously approved indications. Velcade is a proteasome inhibitor that is indicated for the treatment of multiple myeloma as well as mantle cell lymphoma in patients who have received at least 1 prior therapy. The recommended dose of Velcade is 1.3 mg/m2 administered either subcutaneously or as a 3- to 5-second bolus intravenous injection.
Dosage Form: Single-use vial for injection: 3.5 mg bortezomib
For More Information: www.velcade.com/subcutaneous