New Rx, indication, generics, and OTC.
The month of March saw several pediatric approvals.
Sanofi Pasteur has announced FDA approval of its Quadracel (diphtheria and tetanus toxoids and acellular pertussis adsorbed and inactivated polio virus; DTaP-IPV) vaccine for active immunization against diphtheria, tetanus, pertussis, and poliomyelitis in children four through six years of age. The new combination vaccine has the potential to reduce the number of vaccinations needed for children in this age group. The CDC recommends that children four through six years of age receive both their fifth dose of the DTaP vaccine and their fourth dose of IPV vaccine series. Quadracel vaccine can be administered as a fifth dose in the DTaP series and as a fourth or fifth dose in the IPV series. Results of a phase 3 study indicate that Quadracel vaccine has safety and immunogenicity profiles similar to those of separately administered DAPTACEL and IPOL vaccines. (www.sanofipasteur.us)
FDA has approved dinutuximab (Unituxin; United Therapeutics) as part of first-line therapy for pediatric patients with high-risk neuroblastoma, a type of cancer that most often occurs in young children. An antibody that binds to the surface of neuroblastoma cells, dinutuximab was approved for use as part of a multimodality regimen, including surgery, chemotherapy, and radiation therapy, for patients who achieved at least a partial response to previous first-line multiagent, multimodality therapy. FDA granted it priority review and orphan product designation, and issued the manufacturer a rare pediatric disease priority review voucher, which confers priority review for a subsequent drug application that would not otherwise qualify for priority review. (www.unither.com)
FDA has approved cholic acid capsules (Cholbam; Asklepion Pharmaceuticals) to treat adults and children three weeks of age and older who have rare bile acid synthesis disorders resulting from single enzyme defects. It is also approved to treat patients with peroxisomal disorders (including Zellweger spectrum disorders). Patients who have these rare genetic conditions affecting metabolism show symptoms of liver disease, steatorrhea, and complications from decreased ability to absorb fat-soluble vitamins. If untreated, patients fail to grow and can develop life-threatening liver injury. This is the first treatment for this condition approved by FDA, which also gave it a rare pediatric disease priority review voucher, the second one issued in March. (www.asklepionpharm.com)
Also in March, Actavis announced FDA approval of asenapine (Saphris) for treatment of manic or mixed episodes associated with bipolar I disorder in pediatric patients 10 to 17 years of age. The company stated that this is the first atypical antipsychotic to be approved for pediatric patients with bipolar I disorder in the last five years; it is the only formulation available in a sublingual form. The black-cherry flavored tablets will be available in the second quarter of 2015 in 2.5-, 5-, and 10-mg tablets. (www.actavis.com)
FDA has expanded the approved use for aflibercept injection (Eylea; Regeneron Pharmaceuticals) to treat diabetic retinopathy in patients with diabetic macular edema. In 2014, FDA granted Eylea breakthrough therapy designation and priority review for this indication. According to Regeneron, “In addition to improving visual acuity in people with DME, Eylea also improves these patients’ retinal vessel damage, or retinopathy. Eylea is the only treatment option for diabetic retinopathy in patients with DME that is approved for less than monthly dosing after an initial monthly dosing period.” (www.eylea.com) (product image courtesy of Regeneron)
Camber Pharmaceuticals has announced the launch of sildenafil 20-mg tablets. The generic version of Pfizer’s Revatio tablets, the drug is used to treat pulmonary hypertension. (www.camberpharma.com) (Product image courtesy of Camber Pharmaceuticals)
Promius Pharma has announced that its isotretinoin (Zenatane) capsules USP are now available in a 30-mg dose. Zenatane, the AB-rated equivalent to Roche’s Accutane 30-mg, has been introduced in response to dermatologists who have continued to request this strength of the drug. Zenatane 30 mg will be supported by The Promius Promise, a pharmacy service designed specifically to support Zenatane prescribers and patients. The Promius Promise program is designed to assist with patient education about treatment requirements and deliver Zenatane within 24 hours to U.S. locations, at a reduced, if not zero out-of-pocket expense, for eligible patients. (www.promiuspharma.com)
Actavis has launched clobetasol cream 0.05%, generic for PharmDerm’s Temovate, a high-potency topical corticosteroid treatment used to relieve “the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.” (www.actavis.com)
Glenmark Generics has announced the U.S. market approval and introduction of trandolapril/verapamil HCl extended-release tablets, the generic equivalent of AbbVie’s Tarka, indicated for the treatment of hypertension. (us.glenmark-generics.com)
FDA has granted final approval to Mylan and Actavis/Watson for generic versions of celecoxib, Pfizer’s blockbuster arthritis drug Celebrex, allowing the companies to share 180-day exclusivity with Teva. (www.mylan.com) (www.actavis.com)
Afaxys has announced the nationwide launch of levonorgestrel 1.5 mg (EContra EZ), the company’s first over-the-counter emergency contraceptive offered to the public health sector. A single tablet taken orally, the product works by delaying or preventing ovulation. The emergency contraceptive can be used up to 72 hours after
unprotected sex or suspected contraceptive failure, but it is more effective when taken as soon as possible. Afaxys states that EContra EZ is the sixth drug and second emergency contraceptive to join the company’s portfolio of FDA-approved and branded generic oral and emergency contraceptive products. (www.afaxys.com) (Product image courtesy of Afaxys)
Probiotics manufacturer Pharmax has announced the availability of two new infant supplements: HLC Baby B and HLC Baby F. HLC probiotics are proprietary human-sourced strains of microfloral bacteria with strong epithelial adherence and a naturally high tolerance to stomach acid.
The HLC Baby supplements are available in a powdered format that dissolves easily into breast milk, formula, or water, and are free of gluten and soy. According to the company, “Healthy gut flora play an important role in early immune stimulation, and variations in gut colonization at early ages have been associated with the development of atopy. Our new HLC Baby probiotic supplements support early colonization of bacteria in an infant’s gut to reduce incidence of skin sensitivity.” (www.seroyal.com/brands/pharmax) (Product image courtesy of Pharmax)
In April, AZO will introduce new AZO Yeast Plus to its urinary and vaginal health portfolio. The new product, like its
predecessor, AZO Yeast, relieves symptoms of itching and burning with homeopathic ingredients. The new product also alleviates occasional vaginal odor and discharge. One tablet should be taken by mouth three times a day for as long as symptoms persist. For occasional support, the company recommends use of one tablet daily. (www.azoproducts.com) (Product image courtesy of AZO)
Vitalah has introduced Sport Oxylent, a comprehensive three-in-one supplement drink said to support energy, stamina, and recovery through a formulation of micronutrients derived from ingredients that include blueberry, electrolytes, antioxidants, an assortment of minerals, and vitamins C, D, B6, and B12. According to the company, the product includes the “highest quality cutting-edge ingredients on the market that are backed by science and available in the most absorbable form for the body’s use.” Purchasing Oxylent products supports Vitamin Angels - a global nonprofit organization that provides undernourished children with nutritional supplements. (www.oxylent.com) (Product image courtesy of Vitalah)