New products for pharmacists 08-10-2014

New drugs

Image courtesy of InnocutisInnocutis has announced the North American launch of acyclovir (Sitavig) 50 mg buccal tablets, licensed from BioAlliance Pharma, for treatment of herpes labialis. A single dose of this medication “provides a high sustained-release local exposure of acyclovir in oral mucosa,” says a company statement. The tablets adhere to the patient’s gum, above the canine tooth, on the side of the lip where a cold sore is present. This method of drug delivery makes the product a treatment breakthrough, says the company. Studies show that when the dose is applied as soon as symptoms appear, it can often stop the episode there and then. Patients can find the product at local retail pharmacies. (www.sitavig.com)

Late in July, FDA approved Purdue Pharma’s oxycodone hydrochloride and naloxone hydrochloride extended-release tablets (Targiniq ER), an extended-release/long-acting (ER/LA) opioid analgesic for pain that requires daily, around-the-clock, long-term opioid treatment and for which there are no other adequate treatment options. The naloxone component, which blocks the euphoric effect, is meant to deter abuse through snorting or injection. Overdose can lead to death. Post-marketing studies have been called for by FDA, as well as a Risk Evaluation and Mitigation Strategy (REMS) for provider education on use of the drug. (www.purduepharma.com)

Image courtesy of Upsher-SmithUpsher-Smith has announced FDA approval of its testosterone gel for topical use CIII (Vogelxo), indicated to replace testosterone in men with deficient or absent endogenous testosterone. It is specifically indicated to treat primary hypogonadism (congenital or acquired) or hypogonadotropic hypogonadism (congenital or acquired). The recommended starting dose for adult males is 50 mg of testosterone (one tube, one packet, or four pump actuations) applied topically once daily at approximately the same time each day. It should be applied to clean, dry, intact skin of the shoulders and/or upper arms. To prevent secondary exposures, it is important for patients to wash hands with soap and water and cover clothing once the gel has dried, and the product carries a black-box warning to that effect. (www.upsher-smith.com)

FDA has approved idelalisib (Zydelig; Gilead), to treat patients with three types of blood cancers. The drug was the third to receive breakthrough therapy designation for treatment of chronic lymphocytic leukemia (CII). It is indicated for combination use with Rituximab in patients whose CII has relapsed. FDA also granted idelalisib accelerated approval to treat patients with relapsed follicular B-cell non-Hodgkin lymphoma (FL) and relapsed small lymphocytic lymphoma (SLL), another type of non-Hodgkin lymphoma. Idelalisib is intended for use in patients who have received at least two previous systemic therapies. The product carries a boxed warning noting fatal and serious toxicities connected with its use, including liver toxicity, colitis, pneumonitis, and intestinal perforation. The approval calls for a REMS to ensure that healthcare providers likely to prescribe Zydelig are fully apprised of these risks. (www.gilead.com)

Early in July, FDA granted accelerated approval to belinostat (Beleodaq; Spectrum Pharmaceuticals) to treat patients with relapsed or refractory peripheral T-cell lymphoma. The product will be available through specialty pharmacies. It is supplied as a lyophilized powder in 500-mg single-use vials for intravenous injection after reconstitution. The company expected to launch the product by the end of July. (www.beleodaq.com)

Upsher-Smith has announced U.S. availability of its once-daily, broad-spectrum antiepileptic topiramate extended-release capsules (Qudexy XR), available in 25-mg, 50-mg, 100-mg, 150-mg, and 200-mg dosage strengths. FDA approved the product in March 2014 as initial monotherapy for patients 10 years of age and older with partial-onset seizures (POS) or primary generalized tonic-clonic seizures. It has also been approved as adjunctive therapy for patients two years of age and older diagnosed with POS, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome. Patients who have difficulty swallowing can sprinkle the contents of a capsule onto a spoonful of soft food. Patients should not take the product if they have metabolic acidosis and also take metformin. Serious side effects include a variety of eye and vision problems, fever, metabolic acidosis, high levels of ammonia in the blood, kidney stones, low body temperature, confusion and disrupted mental processes, and dizziness or loss of coordination. (www.qudexyxr.com).

Salix Pharmaceuticals has announced FDA approval of its C1 esterase inhibitor [recombinant] (Ruconest) to treat symptoms of acute hereditary angioedema (HAE). HAE is a rare genetic condition that can cause rapid swelling of the hands, feet, limbs, face, intestinal tract and other body parts, including face and windpipe. Adult and adolescent patients should receive 50 IU/kg in a single dose to treat an acute attack. The first recombinant (i.e., not derived from human plasma) treatment for HAE, this product was designated an orphan drug by the FDA. It is manufactured in the Netherlands by Pharming Group NV; Salix subsidiary Santarus will handle U.S. distribution. (www.ruconest.com)

FDA has approved Eagle Pharmaceuticals’ dantrolene sodium (Ryanodex) for injectable suspension, indicated for the treatment of malignant hyperthermia (MH), a potentially fatal disorder triggered when susceptible individuals come in contact with certain anesthetic products. FDA granted the product orphan drug status in 2013 and priority status review in March of this year. The company states that the product represents the first significant
development in MH treatment options in three decades and may become standard of care during surgeries because anesthesiologists can prepare and administer it in less than a minute, as opposed to IV formulations, which take longer to administer. Dantrolene sodium is the only antidote for MH. National and regional drug wholesalers will begin taking orders this month. (www.ryanodex.com)

New generics

Pfizer subsidiary Greenstone LLC is offering doxazosin mesylate tablets

Image courtesy of Greenstone LLC, its authorized generic version of Pfizer’s Cardura, to treat hypertension and both urinary outflow obstruction and obstructive and irritative symptoms associated with benign prostatic hyperplasia. The tablets will be offered in dosage strengths of 1 mg, 2 mg, 4 mg, and 8 mg. (www.greenstonellc.com)

Dr. Reddy’s has launched duloxetine delayed-release capsules USP, 20 mg, 30 mg, and 60 mg, a generic therapeutic equivalent of Eli Lilly’s Cymbalta. Cymbalta carries a black-box warning about suicidality in children, adolescents, and young adults. (www.drreddys.com)

Dr. Reddy’s has also launched paricalcitol capsules in the United States, generic for AbbVie’s Zemplar capsules, used to treat secondary hyperparathyroidism associated with chronic kidney disease. The product is available in 1-, 2-, and 4-µg strengths. (www.drreddys.com)Upsher-Smith has launched what it terms “the first and only generic transdermal testosterone gel available in three convenient configurations” (50-mg unit-dose tubes, 50-mg packets, and 12.5-mg metered-dose pumps). The testosterone gel CIII (1%), is the generic equivalent to the company’s branded product Vogelxo CIII, approved in June of this year to treat testosterone deficiency in men. The product carries a boxed warning stating the need to avoid secondary exposures to the gel. The gel can cause serious side effects and is flammable until dry. (www.upsher-smith.com)

Upsher-Smith has also launched a generic version of its own recently approved topiramate extended-release capsules (Qudexy XR) for treatment of partial-onset seizures in patients 10 and older. As with the branded product, the authorized generic will be available in 25-mg, 50-mg, 100-mg, 150-mg, and 200-mg strengths.  (www.upsher-smith.com)FDA has given first-to-file approval to Ohm Laboratories’ valsartan tablets, generic for Diovan, the hypertension treatment from Novartis, in 40, 80, 160, and 320 mg. Ohm is the New Jersey production arm of Ranbaxy, which has been in hot water with FDA over numerous quality control problems in India and now is in the process of being acquired by Sun Pharmaceuticals. (www.ranbaxy.com)

Image courtesy of Ohm LaboratoriesFDA has given first-to-file approval to Ohm Laboratories’ valsartan tablets,  generic for Diovan, the hypertension treatment from Novartis, in 40, 80, 160, and 320 mg. Ohm is the New Jersey production arm of Ranbaxy, which has been in hot water with FDA over numerous quality control problems in India and now is in the process of being acquired by Sun Pharmaceuticals. (www.ranbaxy.com) 

generic for Diovan, the hypertension treatment from Novartis, in 40, 80, 160, and 320 mg. Ohm is the New Jersey production arm of Ranbaxy, which has been in hot water with FDA over numerous quality control problems in India and now is in the process of being acquired by Sun Pharmaceuticals. (www.ranbaxy.com) Sandoz, Novartis’ generic pharma division, has launched an authorized generic version of valsartan, available in 40-, 80-, 160-, and 320-mg strength tablets. (www.sandoz.com)

OTC

Image courtesy of GlaxoSmithKline FDA has approved GlaxoSmithKline’s fluticasone propionate 50 mcg spray(Flonase Allergy Relief) as an OTC treatment. It is the first and only over-the-counter nasal spray indicated for temporary relief of all nasal and eye-related allergy symptoms. The company expects the product to be available at full prescription strength for patients seeking 24-hour non-drowsy allergy relief in early 2015. (www.Flonase.com)

Image courtesy of EuroPharma

EuroPharma, the maker of the Terry Naturally product line, has announced the launch of SinuCare Extra Strength, a double-strength form of its popular SinuCare. The enteric-coated capsule is a blend of the concentrated oils of lemon, myrtle, and eucalyptus, in a base of extra virgin olive oil, formulated to maintain clear sinus and bronchial passages. (www.EuroPharmaUSA.com)

Image courtesy of Skin Sake

From Skin Sake, a product line created by an Arkansas pharmacist, comes Booty Goo [7], a diaper ointment said by the manufacturer to be acknowledged by FDA for its high standard of active ingredients. These include zinc oxide (25%), Peruvian balsam, vitamin E, aloe, Acidum Boricum (antibacterial germicide), white petrolatum, mineral oil, and castor oil. Booty Goo is widely available through many distributors and pharmacies, including Walgreens. (wwwskinsake.com)