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Weekly Drug News Round Up - December 31, 2014

Dyloject NSAID Injectable Approved for Pain Relief

Dyloject can be given every 6 hours as needed, not to exceed 150 mg per day Read More...

Nonsteroidal anti-inflammatory drugs (NSAIDs) are used worldwide as a non-opioid option or for added pain relief. This week, the U.S. Food and Drug Administration (FDA) approved Dyloject (diclofenac sodium) injection, an NSAID for acute, moderate-to-severe pain used alone or in combination with opioid analgesics. Dyloject is given in an intravenous (IV) bolus of 37.5 milligrams (mg) and does not require dilution. Common side effects include nausea, constipation, headache, infusion site pain, dizziness, and vomiting Ketorolac (Toradol) is another injectable NSAID that can be given via intramuscular or IV injection, does not require dilution, and is available in a generic formulation.

Namzaric Combo Approved for Alzheimer's Disease

Actavis expects to launch Namzaric in the second quarter of 2015 Read More...

Namzaric (memantine hydrochloride extended-release and donepezil hydrochloride) is an NMDA receptor antagonist and acetylcholinesterase inhibitor fixed-dose combination for the treatment of moderate to severe Alzheimer’s disease. Namzaric is approved as a once-daily oral capsule for patients currently taking memantine (10 mg twice daily or 28 mg extended-release once-daily) and donepezil 10 mg. The capsule may also be opened and sprinkled on food for patients who have trouble swallowing. Namzaric will be available in two dosage strengths as memantine extended release/donepezil, either 28/10 mg, or 14/10 mg for patients with severe renal impairment.

Alcon’s Xtoro Approved for Swimmer’s Ear

Swimmer's ear is an infection in the outer ear canal that goes from the outside of the ear to the eardrum Read More...

Swimmer’s ear, also known as acute otitis externa, causes inflammation of the ear canal leading to pain, swelling, redness, and discharge from the ear. The U.S Food and Drug Administration (FDA) has approved Alcon’s Xtoro (finafloxacin otic suspension), an ear drop in the fluoroquinolone class for swimmer’s ear caused by Pseudomonas aeruginosa and Staphylococcus aureus. Among 560 participants whose swimmer’s ear was confirmed to be caused by P. aeruginosa or S. aureus, 70 percent who received Xtoro achieved clinical cure versus 37 percent who received the vehicle (the solution minus the drug).

Galderma’s Soolantra OK’d for Treatment of Rosacea

Active ingredient ivermectin has been reported to have both anti-inflammatory and antiparasitic activity Read More...

Rosacea is a common skin condition that may be due to the generally harmless microscopic Demodex folliculorum mite. The U.S. Food and Drug Administration (FDA) has approved Soolantra (ivermectin), a topical antiparasitic with anti-inflammatory properties for the treatment of rosacea potentially caused by this skin mite. In studies, continuous improvements of rosacea lesions were seen as early as week two of treatment. In head-to-head studies with metronidazole - the current gold standard - Soolantra was shown to be more effective from week three onwards. Commons side effects with Soolantra include skin burning or irritation.

Novo Nordisk’s Saxenda Approved for Weight Management

Saxenda and Victoza contain the same active ingredient (liraglutide) at different doses (3 mg and 1.8 mg, respectively) Read More...

The U.S. Food and Drug Administration (FDA) has approved Saxenda (liraglutide) injection for chronic weight management. Liraglutide is also approved at a lower dose for use in type 2 diabetes (brand name Victoza), but the two drugs should not be used together or with any other glucagon-like peptide-1 (GLP-1) receptor agonist. Saxenda is for obese or overweight patients based on their BMI with at least one weight-related condition such as hypertension, type 2 diabetes, or high cholesterol. In one clinical trial, the average weight loss was 4.5 percent from baseline weight compared to treatment with a placebo (inactive pill) at one year.