New Products for Pharmacists 08-10-2015


New Rx, generics, and OTC

Rx Care

New drugs

In July, FDA approved alirocumab (Praluent; Sanofi Aventis/Regeneron), described as the first approved cholesterol-lowering treatment in a new class of drugs known as proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors. An injectable monoclonal antibody, alirocumab is approved for use in addition to diet and maximally tolerated statin therapy in adult patients with heterozygous familial hypercholesterolemia  or patients with clinical atherosclerotic cardiovascular disease such as heart attacks or strokes, who require additional lowering of LDL cholesterol. (

EntrestoAlso in July, FDA approved Novartis’ sacubitril/valsartan (Entresto), a twice-daily therapy formulated to reduce risk of cardiovascular death and hospitalization for patients with chronic heart failure and reduced ejection fraction. It is usually given with other heart failure therapies, in place of an ACE inhibitor or other angiotensin receptor blocker (ARB). The neprilysin inhibitor sacubitril, a new molecular entity, is given in combination with valsartan in film-coated tablets, available in three dosage strengths: 24/26 mg, 49/51 mg, and 97/103 mg. The program Entresto Central offers various patient services, including assistance with health insurance questions and prescription co-pay programs for eligible patients. The product carries a boxed warning for fetal toxicity and should be discontinued as soon as pregnancy is detected. ( image courtesy of Novartis)

FDA has approved daclatasvir (Daklinza; Bristol-Myers Squibb), a new treatment for chronic hepatitis C virus genotype 3 infections, said by the manufacturer to be one of the genotypes most difficult to treat. Given orally, once daily,  in combination with sofosbuvir, daclatasvir has demonstrated safety and efficacy to treat genotype 3 HCV
infections without the need for co-administration of interferon or ribavirin. Daclatasvir safety information includes a warning of serious symptomatic bradycardia in cases of coadministration with sofosbuvir and amiodarone, as well as possible risk of adverse reactions or loss of virologic response due to drug interactions. (

In July, FDA also approved ombitasvir, paritaprevir, and ritonavir (Technivie; Abbvie) for once-daily use in combination with ribavirin to treat chronic hepatitis C genotype 4. It is the first treatment option for patients with genotype 4 HCV infections that does not require use of interferon. The three drugs included in Technivie are also included in Viekira Pak, previously approved for the treatment of HCV genotype 1 infection. Technivie carries a warning about the occurrence, in approximately 1% of clinical trial participants, of elevation liver enzymes to more than five times the upper limit of normal. Elevations occurred more frequently in women taking contraceptives containing ethinyl estradiol; such use must be discontinued before use of Technivie begins. (

PrestaliaSymplmed has announced that its perindopril arginine and amlodipine besylate (Prestalia) tablets are now available by prescription in the United States through its patient-membership program bpCareConnect and in pharmacies nationwide. The product is the first fixed-dose combination of an ACE inhibitor and a calcium channel blocker indicated for patients not adequately controlled with monotherapy. It can also be used as an initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals. This product carries a boxed warning for fetal toxicity and should be discontinued as soon as pregnancy is detected. ( image courtesy of Symplmed)


Epiduo Forte Gel Pump

July also saw FDA approval of Galderma’s adapalene and benzoyl peroxide gel 0.3%/0.25% (Epiduo Forte Gel], an antibiotic-free topical treatment for patients with moderate-to-severe acne vulgaris. Dosed once daily by pump, the product will be available by prescription in early September. ( (Product image courtesy of Galderma)


New generics

July was a busy month for generic Namenda launches. Amneal, Dr. Reddy’s, and Mylan all launched memantine HCl immediate release tablets in 5-mg and 10-mg strengths. Namenda (Allergan, formerly Actavis) is indicated for the treatment of dementia related to Alzheimer’s disease. ( ( (

Other recent Amneal launches include: tobramycin inhalation solution (a generic equivalent of Novartis’ Tobi inhalation solution), the first inhalation solution formulation offered by Amneal; six different strengths of temozolomide capsules (AB-rated to Merck’s Temodar), a chemotherapy drug used to treat brain cancer; and divalproex sodium extended release (AB-rated to Depakote ER; Abbvie) in 250-mg and 500-mg tablets, used to treat some types of seizures, bipolar disorder, and migraine headaches. (

Almotriptan MalateTeva has launched almotriptan malate tablets, AB rated and bioequivalent to Janssen’s Axert tablets, used to treat acute migraine pain in adults and children 12 years of age and older. ( image courtesy of Teva Generics)

Aspirin/Dipyridamole capsulesJuly also saw Teva’s U.S. launch of aspirin/extended-release dipyridamole capsules (a generic version of Boehringer Ingelheim’s Aggrenox), used to reduce stroke risk in patients who have had a transient ischemic
attack or a stroke caused by a blood clot.  ( image courtesy of Teva Generics)

Aurobindo has announced FDA approval of its flecainide acetate tablets, generic for Tambocor (Meda Pharmaceuticals), in 50-, 100- and 150-mg dosage strengths. This product is formulated to prevent paroxysmal
supraventricular tachycardias, as well as to prevent and treat certain severe ventricular-related arrhythmias. (

FDA has also approved Aurobindo’s extended phenytoin sodium capsules in 100-mg dosage strength, the generic equivalent of Pfizer’s Dilantin, an anti-epileptic medication meant for treating and preventing seizures in patients during or after neurosurgery. (

Also newly approved by FDA is Aurobindo’s azithromycin for injection USP, 500 mg/vial, the bioequivalent and therapeutic equivalent to Pfizer’s Zithromax, a macrolide antibacterial drug used to treat infections caused by susceptible microorganisms in conditions such as community-acquired pneumonia and pelvic inflammatory disease. (

FDA has also approved Aurobindo’s entacapone tablets USP, 200 mg, generic ally equivalent to Novartis’ Comtan tablets 200 mg, used in the treatment of Parkinson’s disease. (

Hospira has announced that it will launch bivalirudin for injection, in a single-dose flip-top vial. This is a generic version of The Medicines Company’s Angiomax, an anticoagulant indicated for patients with unstable angina
undergoing coronary angioplasty, as well as for those undergoing percutaneous coronary intervention or those with heparin-induced thrombocytopenia, among other indications. A differentiated presentation of the 250-mg
bivalirudin for injection, in what Hospira described as its ADD-Vantage vial, is in the works. (

Sandoz has launched its own generic version of bivalirudin for injection under a supply and distribution agreement with the Medicines Company. (

Mylan has launched bexarotene 75-mg capsules, its generic version of Valeant’s Targretin, used to treat
patients with cutaneous t-cell lymphoma who are refractory to at least one prior systemic therapy. According to Mylan, this is the first and only generic form of Targretin. (



Hyland’s has launched Hyland’s 4 Kids Bumps ’n Bruises with Arnica, a topical ointment stick that the manufacturer describes as providing safe and effective relief of bruising, pain and swelling with Arnica Montana, a homeopathic treatment for these conditions. This product has been designated by Target stores as part

Curamed 200of their “Made to Matter” wellness collection. (

St. John's Wort 900EuroPharma, which manufactures the Terry Naturally brand of dietary supplements, announced the launch of Vegan CuraMed 200 mg, a formulation of “clinically studied, high absorption curcumin blended in a patented process with turmeric essential oil and tumerones.” Curcumin is used for its antioxidant and anti-inflammatory properties. ( image courtesy of EuroPharma)

EuroPharma’s Terry Naturally has also launched St. John’s Wort 900, which the manufacturer says is distinguished by the fact that only a single daily dose is necessary. The product is intended to reduce the stress of remembering to take several doses throughout the day in people whose mood and mental wellbeing need support. The product contains 0.3% hypericin. ( image courtesy of EuroPharma)

Recticare Medicated Anorectal WipesHemorrhoid sufferers have a new alternative with which to treat flareups, especially when away from home. Ferndale Healthcare, distributor and marketer of RectiCare Anorectal Cream, has introduced its latest product, RectiCare Medicated Anorectal Wipes [8]. Formulated with lidocaine 5% and glycerin 20%, these dual-action wipes are described as providing effective relief from the pain, itching, and discomfort of hemorrhoids and other anorectal disorders, while also forming a protective coating over inflamed tissues to temporarily protect irritated and inflamed perianal skin. Each pack contains 12 individually packaged premoistened wipes that are convenient, discreet, and portable. The product is now available at Rite Aid and Walgreens locations. (

Cosmederm Bioscience has expanded its line of anti-itch products with the new TriCalm Clinical Repair Cream and TriCalm Extra Strength Spray. Product literature describes Clinical Repair Cream as ideal for those suffering from dry, itchy skin. The Extra Strength Spray is formulated for use on contagious or hard-to-reach areas, such as rashes from poison oak or ivy. Both products are steroid-free. (

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