Product Updates for Pharmacists 12-10-2015


New Rx, generics, and OTC


New drugs

FDA has given accelerated approval to the first seasonal influenza vaccine containing an adjuvant. Fluad (Novartis), a trivalent vaccine produced from three influenza virus strains (two subtype A and one type B) and manufactured with squalene oil in an egg-based process, is approved for the prevention of seasonal influenza in people 65 years of age and older. (

After priority review, the first noninjectable form of naloxone, a nasal spray formulation of naloxone hydrochloride (Narcan, Adapt Pharma), has received accelerated approval from FDA. Each device delivers 4 mg of naloxone; this is done most effectively when patient is supine. No special training for use is required. Medical attention should be sought immediately. The nasal spray can cause severe opioid withdrawal in patients who are opioid dependent. (

FDA has been busy with cancer-related therapies lately. Here are some of its recent approvals.

In November, Ixazomib (Ninlaro; Millennium/Takeda) was approved for use in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one previous therapy. The first approved oral proteasome inhibitor, ixazomib received priority review and orphan drug status. The most common side effects are diarrhea, constipation, thrombocytopenia, peripheral neuropathy, nausea, peripheral edema, vomiting, and back pain. (

Also in November, FDA approved Genentech’s cobimetinib (Cotellic), to be used in combination with vemurafenib (a Genentech product marketed in the U.S. as Zelboraf) to treat advanced melanoma that has spread to other parts of the body or can’t be removed by surgery, and that has a certain type of abnormal gene (BRAF V600E or V600K mutation). Cotellic received both priority review and orphan drug designation. Women taking cotellic should avoid becoming pregnant, as the medication can cause harm to a developing fetus. (

Receiving accelerated approval as well as breakthrough therapy designation, priority review, and orphan drug designation, osimertinib (Tagrisso; Astra Zeneca), an oral medication, is indicated to treat patients with advanced non-small cell lung cancer whose tumors have a specific epidermal growth factor receptor (EGFR) mutation (T790M) and whose disease has gotten worse after treatment with other EGFR-blocking therapy. It was approved with a companion diagnostic test. Osimertinib may cause serious side effects, including inflammation of the lungs and injury to the heart. It also may cause harm to a developing fetus. FDA noted that continued approval for this indication might be contingent upon further confirmatory studies. (

Worthy of note is the recent approval of talimogene laherparepvec  (Imlygic; Biovex/Amgen), the first FDA-approved oncolytic virus therapy. A genetically modified live herpes simplex virus type 1 therapy, it is used to treat melanoma lesions in the skin and lymph nodes that cannot be removed completely by surgery. Treatment is a series of injections directly into the melanoma lesions. Because herpes virus infection can result from this treatment, it should not be given to individuals with suppressed immune systems or who are pregnant. (

Also in November, FDA approved three biologic cancer therapies. It gave breakthrough designation, orphan drug status, priority review, and accelerated approval to daratumumab (Darzalex; Janssen Biotech) to treat patients with multiple myeloma who have received at least three previous treatments. Given by infusion, Darzalex is the first monoclonal antibody approved for treating multiple myeloma. Women who are pregnant should not use Darzalex, and women planning to become pregnant should use effective contraceptives during and for at least three months after treatment. (

The second monoclonal antibody to be approved by FDA for use in the treatment of multiple myeloma, elotuzumab (Empliciti; Bristol-Myers Squibb Company) was awarded breakthrough therapy designation, orphan drug designation, and priority review; it is indicated for use in combination with lenalidomide and dexamethasone in patients with multiple myeloma who have previously received one to three other therapies. (

Another monoclonal antibody approved in November is necitumumab (Portrazza; Eli Lilly), indicated for use in combination with gemcitabine and cisplatin to treat patients with metastatic squamous non-small cell lung cancer who have not previously received medication specifically for treating their advanced lung cancer. Necitumumab carries a boxed warning that cites serious treatment risks, including cardiac arrest and sudden death, as well as hypomagnesemia. (


New generics

Ajanta Pharma has announced the launch of its generic version of montelukast sodium granules (Singulair; Merck), in 4-mg sachets, indicated to relieve allergy symptoms and for use as a long-term asthma treatment in children six months to five years of age. (

Dr. Reddy’s has acquired exclusive worldwide intellectual property rights for fondaparinux sodium injection from its Australian partner, Alchemia Limited. The generic anti-coagulant drug is the bioequivalent of GlaxoSmithKline’s Arixtra. (

Pfizer U.S. subsidiary Greenstone LLC has announced the launch of its ethosuximide capsules (250 mg) and ethosuximide oral solution (250 mg/5 mL), authorized generic equivalents to Pfizer’s Zarontin capsules and oral solution, indicated for the control of petit mal epilepsy. (www.greenstonellc)

FDA has given final approval to Aurobindo Pharma for sildenafil tablets, 20 mg, bioequivalent and therapeutically equivalent to Pfizer’s Revatio tablets, indicated to treat pulmonary arterial hypertension in adults. (


New from Valeant Pharmaceuticals North America is CeraVe Healing Ointment, a moisturizing complex developed by dermatologists over a three-year period and formulated to help protect and soothe cracked, dry skin. It contains no lanolin; its active ingredient, petrolatum, constitutes 46.5% of the formula, and it features a blend of mineral waxes. Available at Walgreens, CVS, Walmart, Target, and Rite Aid in January 2016. (

From AcneFree comes the new Sonic Advanced Cleansing Duo. The two-speed silicone facial cleansing brush deep-cleans pores using skin-stimulating technology that provides up to 8,000 pulsations per minute. The oil-free purifying cleanser features 2.5% micro-benzoyl peroxide to help fight acne bacteria and control breakouts. Available at Walmart as of December, the product will be available at other retailers beginning in January 2016. (


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