New Rx, indications, generics, and OTC
FDA has approved Probuphine (Titan/Braeburn), the first implantable buprenorphine therapy for maintenance treatment of opioid addiction. Inserted into the arm, the tiny dispenser provides a constant low dose of medication for six months. The drug can be extracted from the implant by accidental or intentional means; regular physician follow-up is recommended. Probuphine is dispensed according to a REMS program and accompanied by a boxed warning and Medication Guide. (braeburnpharmaceuticals.com)
Ahead of the 2016-2017 flu season, FDA has approved Flucelvax Quadrivalent influenza vaccine. The former Novartis product, now owned by CSL/Seqirus, is the first four-strain, cell-culture-based, inactivated seasonal influenza vaccine for persons four years of age and older. (www.seqirus.com)
Genentech's atezolizumab (Tecentriq), a monoclonal antibody, has won accelerated approval to treat advanced urothelial carcinoma that has that progressed after platinum-based chemotherapy. It is now available. Genentech will offer assistance programs for qualified patients through Genentech Access Solutions. (www.Genentech-Access.com)
Eli Lilly has announced the availability at U.S. pharmacy wholesalers of its insulin human injection 500 units/mL. The pre-filled Humulin R U-500 KwikPen, which FDA approved in January, delivers an insulin formulation five times more concentrated than standard U-100 insulin, enabling people with diabetes to inject up to 80% less liquid. Optimized for desktop, tablet, and mobile use, the redesigned product website includes consumer-friendly content and a savings card offer. (www.humulin.com).
FDA has approved Biofrontera's topical prescription drug BF-200 ALA (Ameluz) and medical device BF-RhodoLED for use in photodynamic treatment of mild-to-moderate actinic keratosis lesions on the face and scalp, caused by frequent exposure to the sun's ultraviolet rays. If left untreated, they may develop into squamous cell carcinoma. Product is expected to launch by September. (biofrontera.com/en)
Eisai has announced FDA approval of lenvatinib capsules (Lenvima)18 mg for use with everolimus 5 mg to treat advanced renal cell carcinoma after previous anti-angiogenic therapy. Compared with standard of care, this combination, which had earlier received breakthrough therapy designation and priority review, nearly tripled progression-free survival. Lenvatinib's first U.S. approval occurred in February 2015 and pertained to patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer. (www.lenvima.com)
Following previous designations of orphan drug status, breakthrough therapy, and priority review, FDA has granted accelerated approval to nivolumab (Opdivo; Bristol-Myers Squibb) to treat classical Hodgkin lymphoma that has relapsed or progressed after autologous hematopoietic stem cell transplantation and post-transplantation brentuximab vedotin (Adcetris). This is the eighth approval for nivolumab in less than two years across four cancer categories. (www.opdivo.com)
In an odd stroke of timing, FDA approved an expanded indication for Janssen's combination therapy canagliflozin and metformin HCl (Invokamet) less than a week after it issued a Drug Safety Communication stating that "interim clinical trial results find increased risk of leg and foot amputations, mostly affecting the toes, with the diabetes medicine canagliflozin (Invokana, Invokamet)." The new indication makes Invokamet a first-line treatment for adults with type 2 diabetes who are not taking either canagliflozin or metformin. Invokamet carries a boxed warning for lactic acidosis. (invokanahcp.com)
Aurobindo has announced two approvals: Zolmitriptan tablets, 2.5 mg and 5 mg, generic for Zomig (IPR Pharmaceuticals), to treat acute migraine with or without aura in adults; and fenofibrate, 48 mg and 145 mg, generic for Tricor (Abbvie), to treat high cholesterol and high triglycerides. (www.aurobindo.com)
Another fenofibrate formulation has launched: ANI Pharmaceuticals' authorized generic of Lipofen capsules, in 50-mg and 150-mg dosage strengths.(www.anipharmaceuticals.com)
Mylan has three new launches: Doxycycline hyclate, generic for Mayne Pharma's Doryx, an adjunct treatment for severe acne, in 200-mg delayed-release tablets; frovatriptan succinate, generic for Endo's Frova, to treat acute migraine headaches in adults, 2.5 mg; and hydralazine HCl injection 20-mg/mL, generic for Novartis' Apresoline, to treat severe hypertension when an oral drug is not feasible or a patient's need to lower blood pressure is urgent. (www.mylan.com)
EuroPharma's Terry Naturally brand of dietary supplements has launched CuraMed Breast, combining curcumin, two types of pomegranate seed extract, and grape seed extract, for polyphenols that "protect breast cells from oxidative damage, support healthy cellular development, help cells better eliminate waste materials, and balance hormonal activity involving breast cells."
EuroPharma also has launched GingerMed + Turmerones, formulated to support immunity and cellular health.The ginger oil "is standardized to a minimum of 25% gingerols and shogaols, important plant compounds that provide powerful cellular benefits," while the turmeric oil, a CO2 extraction, contains a minimum of 60% turmerones, including "ar-turmerones," described as "emerging in cellular immune science as a vital antioxidant for DNA protection."(www.europharmausa.com)
Nordic Naturals calls its new launch, ProOmega CRP, "a powerful solution for systemic cellular stress," and describes it as a first-of-its-kind product combining omega-3s, curcumin, and antioxidants, foundational nutrients that support cellular and metabolic health. The combination of 1,500 mg of concentrated omega-3 fatty acids and 600 mg of free-form curcumin, along with 225 mg of reduced L-glutathione and 300 mg of N-acetylcysteine (NAC), is formulated to promote a greater level of balanced, restorative molecular activity through the support of optimal cell function. (www.nordicnaturals.com)