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ParaPRO, LLC (Carmel, IN)
Indication:
The FDA announced approval of Natroba (spinosad) Topical Suspension 0.9%, a pediculicide indicated for the topical treatment of head lice manifestations in children 4 years and older. Head lice are the second most communicable disease among childen after the common cold. Natroba should be applied to dry scalp and hair and rinsed with warm water after 10 minutes. The product contains benzyl alcohol and is not recommended for use in neonates and infants younger than 6 months. Natroba will be available in the first half of 2011.
Dosage Form:
Topical suspension: 4-oz (120-mL) bottles with 9 mg of spinosad per gram of Natroba
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Nuedexta Marketed by:
Avanir Pharmaceuticals Inc (Aliso Viejo, CA)
Indication:
Nuedexta (dextromethorphan hydrobromide and quinidine sulfate) is a combination product indicated for the treatment of pseudobulbar affect (PBA). PBA occurs secondary to a variety of otherwise unrelated neurologic conditions, and is characterized by involuntary, sudden, and frequent episodes of laughing and/or crying that typically occur out of proportion or incongruent to the underlying emotional state. The starting dose of Nuedexta is 1 capsule daily by mouth for 7 days, followed by a maintenance dose of 1 capsule every 12 hours. The need for continued treatment should be reassessed periodically, as PBA spontaneously improves in some patients.
Dosage Form:
Capsules: Dextromethorphan 20 mg/ quinidine 10 mg
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Jalyn Marketed by:
GlaxoSmithKline (Research Triangle Park, NC)
Indication:
Jalyn (dutasteride and tamsulosin HCl) capsules are FDA approved for the treatment of symptomatic benign prostatic hyperplasia in men with an enlarged prostate. Dutasteride is a 5-alpha-reductase inhibitor and tamsulosin is an alpha-adrenergic antagonist. Jalyn should not be used with strong inhibitors of cytochrome P450 (CYP) 3A4 as well as other alpha-adrenergic antagonists, as this may increase the risk of hypotension. Caution should also be exercised when administering Jalyn concomitantly with strong or moderate CYP2D6 inhibitors or warfarin. Patients should swallow 1 capsule whole daily approximately 30 minutes after the same meal each day.
Dosage Form:
Capsules: Dutasteride 0.5 mg and tamsulosin HCl 0.4 mg
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Fortesta Marketed by:
Endo Pharmaceuticals (Chadds Ford, PA)
Indication:
Fortesta (testosterone) Gel for topical use CIII is an androgen indicated for replacement therapy in men for conditions associated with a deficiency or absence of endogenous testosterone, including congenital or acquired primary hypogonadism and congenital or acquired hypogonadotrophic hypogonadism. Fortesta has a starting dose of 40 mg (4 pump actuations) applied topically once daily in the morning to clean, dry, intact skin of the thighs. The dose can be adjusted between a minimum of 10 mg and a maximum of 70 mg.
Dosage Form:
Topical gel: 60-g canisters with a metered dose pump delivering 0.5 g of gel (10 mg of testosterone) per pump actuation
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Novartis AG (Basel, Switzerland)
Indication:
Novartis recently announced the FDA approval of Menveo (meningococcal [groups A, C, Y, and W-135] oligosaccharide diphtheria CRM197 conjugate vaccine), a quadrivalent meningococcal conjugate vaccine indicated for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135 in children aged 2 to 10 years. Menveo was previously approved in 2010 for use in individuals aged 11 to 55 years. The number of meningococcal disease cases varies in the United States, ranging between 1000 and 3000 cases per year.
Dosage Form:
Solution for injection (0.5-mL dose) supplied as a liquid vaccine component that is combined through reconstitution with a lyophilized vaccine component, both in single-dose vials
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750 mg Vancomycin Injection, USP
Marketed by:
Baxter International Inc (Deerfield, IL)
Indication:
Baxter International announced the FDA approval of a premix formulation of Vancomycin Injection, USP, with a strength of 750 mg/150 mL. Vancomycin is an antibiotic indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (beta-lactam—resistant) staphylococci. It is also indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, and for infections caused by vancomycinsusceptible organisms that are resistant to other antimicrobial drugs. Vancomycin Injection is also available in 500-mg/100-mL and 1-g/200-mL strengths.
Dosage Form:
Premixed Solution for Injection: 750 mg/150 mL
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Xgeva Marketed by:
Amgen Inc (Thousand Oaks, CA)
Indication:
The FDA approved Xgeva (denosumab) for the prevention of skeletal-related events in patients with bone metastases from solid tumors. Xgeva is not indicated for the prevention of skeletal-related events in patients with multiple myeloma. The product is administered as a 120-mg dose every 4 weeks as a subcutaneous injection in the upper arm, upper thigh, or abdomen. Calcium and vitamin D should be administered as needed to patients receiving Xgeva to prevent or treat hypocalcemia. Osteonecrosis of the jaw can occur in patients receiving Xgeva, so patients should receive an oral examination prior to starting therapy and should be monitored for symptoms.
Dosage Form:
Single-use vial: 120 mg/1.7 mL
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Aridol Marketed by:
Pharmaxis Inc (Exton, PA)
Indication:
The FDA approved Aridol (mannitol inhalation powder) for the assessment of bronchial hyperresponsiveness in patients 6 years or older who do not have clinically apparent asthma. During the Aridol test, patients inhale increasing doses of a breathable powder form of mannitol. When inhaled, mannitol induces an increase in osmolarity in the airways similar to other bronchial motivation tests. Airway contraction is measured by the amount of air exhaled in 1 second. Aridol should be used as part of a physician’s overall assessment of asthma.
How Supplied:
Each test kit contains dry powder mannitol capsules in graduated doses of 0, 5, 10, 20, and 40 mg and 1 single patient—use inhaler device
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