New Products for Pharmacists 09-10-2015


New Rx, new indications, new generics, new OTC

New drugs

At the end of August, the cholesterol-lowering drug evolocumab (Repatha Injection; Amgen) became the second PCSK9 inhibitor to receive FDA approval, following July’s approval of alirocumab. Evolocumab is indicated for use in addition to diet and statin therapy by adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease, who need to lower their “bad cholesterol” (LDL-C) further. It can also be used along with diet and other LDL-lowering treatments by patients with homozygous familial hypercholesterolemia (HoFH) who require additional lowering of LDL-C. Adults self-administer the drug using a prefilled syringe or prefilled auto-injector; doses are 140 mg twice monthly or 420 mg once a month (recommended for adults with HoFH). Used twice monthly, the drug will cost $14,100 per year; Amgen says it will offer payers “innovative pricing programs”; for prescribers and patients it offers its “RepathaReady” program, described as a comprehensive suite of services to help patients and providers. The manufacturer stated that the drug would ship one week after approval. (

FDA has approved brentuximab vedotin (Adcetris; Seattle Genetics) to treat patients with classical Hodgkin lymphoma (HL) at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation consolidation. It is also approved to treat a rare lymphoma known as systemic anaplastic large cell lymphoma (ALCL). Adcetris is the first new HL treatment to be approved since 1977 and is the first specifically indicated to treat ALCL. (

Boehringer Ingelheim and Eli Lilly have announced FDA approval of empagliflozin/metformin HCl (Synjardy), their jointly held product for treatment of type 2 diabetes. The third product containing the SGLT-2 inhibitor empagliflozin to win FDA’s okay, this product should be used in addition to diet and exercise by adults for whom metformin or empagliflozen alone does not suffice, or who are already taking both drugs. Patients with type 1 diabetes or diabetic ketoacidosis should not take this drug. The product carries a boxed warning about the risk of lactic acidosis resulting from metformin accumulation. (

The first 3D-printed drug has received FDA approval. Levetiracetam (Spritam; Aprecia Pharmaceuticals) was approved for oral use as an adjunctive prescription therapy in the treatment of epilepsy. It is delivered in premeasured doses that disintegrate in the mouth with a sip of liquid. (

Novartis has announced FDA approval of sonidegib (Odomzo capsules) to treat patients with locally advanced basal cell carcinoma that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy. The most serious risks of sonidegib are embryofetal toxicity and rhabdomyolysis. (

FDA has approved the first treatment for “hypoactive sexual desire disorder” in premenopausal women. Flibanserin (Addyi; Sprout Pharmaceuticals), a serotonin 1A receptor agonist and a serotonin 2A receptor antagonist, carries a danger of serious interaction with alcohol, the use of which is contraindicated for women taking flibanserin. It will be available only through certified healthcare practitioners and pharmacies. FDA is requiring both a REMS and an ETASU for this product, because patients who use alcohol while taking it are in danger of fainting as a result of severe low blood pressure. Other symptoms of central nervous system depression are also possible. A boxed warning cites risks to users of alcohol or CYP3A4 inhibitors, as well as to patients with impaired livers. (


New indications

FDA has announced its approval of Purdue Pharma’s oxycodone formulation (OxyContin) for pediatric patients as young as 11 for pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. FDA stated that the purpose of the approval is to help doctors safely prescribe this medication for children in pain. FDA will require Purdue to conduct postmarketing studies aimed at assessing the safe use of the drug by children. FDA stated that it would use all tools available to help prevent misuse and abuse of OxyContin. (

Novartis announced that FDA has expanded the use of eltrombopag (Promacta), used to treat chronic immune thrombocytopenia, to children ages 1 and older. Promacta was approved in June to treat patients ages 6 and older with ITP. The manufacturer states that Promacta is the only oral TPO-receptor agonist that may increase platelet production. The updated label includes a new oral suspension formulation designed for young children who may not be able to swallow tablets. (

Sunovion has announced FDA approval of a new indication for eslicarbazepine acetate (Aptiom) as monotherapy for partial-onset seizures. Approved in 2013 as adjunctive therapy for partial-onset seizures, this product, according to the manufacturer, is now the only once-daily, non-extended-release antiepileptic drug (AED) that can be used alone or in combination with other AEDs in the treatment of partial-onset seizures. (


New generics

Amneal AripiprazoleAmneal has announced the launch of aripiprazole oral solution in 1 mg/mL strength. One of the first available generic forms of Otsuka’s discontinued liquid form of Abilify, an atypical antipsychotic, it is an AA-rated theraputic equivalent. It is now shipping in 150 mL (5 fl oz) bottles through wholesalers, distributors, and directly to the trade. ( (Product image courtesy of Amneal)

Camber EntecavirCamber Pharma has launched entecavir tablets in strengths of .5 mg and 1.0 mg. Generic for Bristol-Myers Squibb’s Baraclude, this product is indicated to treat chronic hepatitis B in adults. ( (Product image courtesy of Camber)

FDA has also approved Aurobindo’s entecavir tablets in 0.5- and 1-mg dosage strengths. (

Aurobindo has received approval, as well, for cetirizine hydrochloride tablets USP, 5 mg and 10 mg, the bioequivalent version of McNeil’s Zyrtec, indicated for temporary relief of symptoms of seasonal allergy or hay fever. (

Dr. Reddy’s has announced the launch and FDA approval of its pramipexole dihydrochloride extended-release tablets, generic for Boehringer Ingelheim’s Mirapex ER, indicated to treat Parkinson’s disease. (

Upsher-Smith has announced FDA approval of memantine HCl in 5-mg and 10-mg strengths, generic for Actavis’ Namenda, indicated to treat moderate-to-severe dementia “of the Alzheimer’s type.”

FDA has approved Mylan’s lidocaine patch 5%, generic for Endo’s Lidoderm, indicated to treat pain from post-herpetic neuralgia. (

Mylan also has announced the U.S. launch of esomeprazole magnesium delayed-release capsules USP, 20 mg and 40 mg, its generic version of AstraZeneca’s Nexium, indicated for the treatment of gastroesophageal reflux disease (GERD) in adults and children ages 1 and older. (


3M has launched the Nexcare Sensitive Skin collection, a new line of hypoallergenic first-aid products specially formulated for sensitive skin. They include Sensitive Skin Adhesive Pads, Sensitive Skin Tape, and a Sensitive Skin Eye Patch. Another new Nexcare product is its Acne Absorbing Covers [3], little patches that work like sponges to absorb oil from acne blemishes, offering an alternative to creams and gels. ( (Product image courtesy of 3M)

New from Genestra Brands, Myo-Inositol is described as an ovarian health-support supplement that delivers 4 g of myo-inositol in each daily serving to support overian and reproductive system function. Available in a gluten-free, dairy-free powder format, Myo-Inositol mixes easily with water or juice. According to the manufacturer, in a clinical trial, myo-inositol supplementation with folic acid better promoted hormonal balance, menstrual regularity, and insulin sensitivity, when compared with the placebo folic acid treatment. (   

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