FDA New Approvals
Alere i Influenza A & B Test
The FDA has granted the first waiver to allow a nucleic acid-based test, the Alere i Influenza A & B test, to be used in a greater variety of healthcare settings. The test was previously only available for use in certain laboratories. Because the FDA granted a waiver under the Clinical Laboratory Improvement Amendments, the Alere i Influenza A & B test can be distributed to a broad variety of non-traditional laboratory sites, including physicians’ offices, emergency rooms, health department clinics, and other healthcare facilities.
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Novartis announced that the FDA has granted accelerated approval of
Bexsero (meningococcal group B vaccine [recombinant, adsorbed]) for active
immunization to prevent invasive meningococcal disease caused by serogroup B
(also known as meningitis B) in adolescents and young adults from 10 years
through 25 years of age.
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Novartis has announced the FDA approval of Cosentyx (secukinumab) for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. Cosentyx selectively binds to IL-17A and inhibits interaction with the IL-17 receptor.
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The FDA has approved AbbVie's Duopa (carbidopa and levodopa) enteral suspension for the treatment of motor fluctuations for people with advanced Parkinson's disease. Duopa is administered using a small, portable infusion pump that delivers carbidopa and levodopa directly into the small intestine for 16 continuous hours via a procedurally-placed tube.
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eRapid Nebulizer System
The eRapid Nebulizer System (eRapid) from PARI has been approved as the first electronic nebulizer by the FDA to deliver Genentech’s Pulmozyme for cystic fibrosis treatment. eRapid is able to reduce average treatment times with Pulmozyme from 6-8 minutes down to 2-3 minutes.
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Bristol-Myers Squibb Company announced that the FDA has approved (atazanavir 300mg and cobicistat 150mg) tablets in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults. Evotaz is coformulated to be one pill, once daily, combining the protease inhibitor atazanavir, marketed as Reyataz (atazanavir 200mg/300mg) capsules, and cobicistat, a pharmacokinetic enhancer marketed by Gilead Sciences, Inc.
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The FDA has approved Glyxambi (empagliflozin/linagliptin) tablets, from Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company, as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes when both empagliflozin and linagliptin are appropriate treatments.
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Pfizer Inc. announced the FDA has granted accelerated approval of Ibrance (palbociclib), in combination with letrozole, for the treatment of postmenopausal women with estrogen receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer as initial endocrine-based therapy for their metastatic disease. Ibrance is available to order immediately through select specialty pharmacies.
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NPS Pharmaceuticals, Inc. has announced that the FDA has approved Natpara (parathyroid hormone) as an adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism. Natpara, a bioengineered replica of human parathyroid hormone, is expected to be available in the second quarter of 2015.
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Norditropin FlexPro 30mg/3.0mL
Novo Nordisk announced the FDA approval of Norditropin (somatropin [rDNA origin] injection) FlexPro 30mg/3.0mL, a prefilled injection pen for patients with growth hormone-related disorders. The FlexPro 30mg/3.0mL device complements the existing portfolio of Norditropin FlexPro products available in 5mg/1.5mL, 10mg/1.5mL, and 15mg/1.5mL pens. Novo Nordisk plans to make Norditropin FlexPro 30mg/3.0mL available by April 2015.
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Alcon, a division of Novartis, has received approval from the FDA of Pazeo (olopatadine hydrochloride ophthalmic solution) 0.7%, for the treatment of ocular itching associated with allergic conjunctivitis. Pazeo solution is anticipated to be available by prescription in the United States in March 2015.
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Baxter International Inc. has announced the FDA has approved Phoxillum Renal Replacement Solutions (BK4/2.5 and B22K4/0) as replacement solutions in continuous renal replacement therapy (CRRT) to correct electrolyte and acid-base imbalances, and in case of drug poisoning when CRRT is used to remove dialyzable substances. Baxter anticipates Phoxillum phosphate-containing solutions will be available in the United States in the second quarter of 2015.
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Symplmed Pharmaceuticals has announced the FDA has approved Prestalia (perindopril arginine and amlodipine) tablets for the treatment of hypertension.
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Janssen announced that the FDA has approved Prezcobix (darunavir 800mg/cobicistat 150mg) tablets, an HIV-1 protease inhibitor combined with a CYP3A4 inhibitor, for the treatment of human immunodeficiency virus in combination with other antiretroviral agents for treatment-naive and treatment-experienced adults with no darunavir resistance-associated substitutions.
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t:flex Insulin Pump
Tandem Diabetes Care, Inc., a medical device company and manufacturer of the t:slim Insulin Pump, has announced that the FDA has granted the Company clearance to market the t:flex Insulin Pump. At 480 units, the insulin reservoir of the t:flex Pump has the largest capacity currently available in the United States. The t:flex Pump is expected to launch in the United States in the second quarter of 2015.
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The FDA has approved TissuGlu, the first tissue adhesive approved for internal use. TissuGlu is a urethane-based adhesive that a surgeon can use to connect tissue flaps made during surgery to remove excess fat and skin or to restore weakened or separated abdominal muscles (abdominoplasty surgery). Connecting the tissue flaps with an internal adhesive may reduce or eliminate the need for postoperative surgical draining of fluid between the abdominoplasty tissue flaps.
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Rockwell Medical, Inc. announced that the FDA has approved its drug Triferic for commercial sale as an iron replacement product to maintain hemoglobin in adult patients with hemodialysis dependent chronic kidney disease.
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FDA New Dosing
CSL Behring announced that the FDA has expanded the administration options for Hizentra, Immune Globulin Subcutaneous (Human), 20% Liquid, to include the ability to individualize therapy with flexible dosing—treatment at regular intervals from daily to once every two weeks (biweekly)—for people with primary immunodeficiency.
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FDA New Indications
Pharmacyclics, Inc. has announced that the FDA has granted single-agent Imbruvica (ibrutinib) regular (full) approval in all lines of therapy as the first and only treatment for patients with Waldenstrom's macroglobulinemia, a rare, indolent type of B-cell lymphoma. This is the fourth indication for Imbruvica, an oral therapy, which received FDA Breakthrough Therapy Designation for this indication in February 2013.
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FDA First-Time Generic Approvals
Shire announced that the FDA approved Vyvanse (lisdexamfetamine dimesylate) Capsules (CII), for the treatment of moderate to severe binge eating disorder in adults, shown to significantly reduce the mean number of binge days per week.
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Generic Version of Nexium
The FDA has approved the first generic version of Nexium (esomeprazole magnesium delayed-release capsules) to treat gastroesophageal reflux disease in adults and children ages 1 and older. Ivax Pharmaceuticals, Inc., a subsidiary of Teva Pharmaceuticals USA, has gained approval to market esomeprazole in 20 and 40mg capsules.
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Generic Version of Orapred ODT
Mylan Inc. has announced the United States launch of its Prednisolone Sodium Phosphate Orally Disintegrating Tablets, 10mg, 15mg, and 30mg. This product is the first generic version of Shionogi's Orapred ODT. Mylan received final approval from the FDA for its Abbreviated New Drug Application and was awarded 180 days of generic drug marketing exclusivity. This product is indicated as an anti-inflammatory or immunosuppressive agent for certain conditions; it is also indicated for the treatment of certain endocrine conditions and for palliation of certain neoplastic conditions.
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Generic Version of Vivelle-DOT
Mylan Inc. has announced the United States launch of its Estradiol Transdermal System USP, 0.025mg/day, 0.0375mg/day, 0.05mg/day, 0.075mg/day, and 0.1mg/day (twice weekly), which is the generic version of Novartis' Vivelle-DOT. Mylan received final approval from the FDA for its Abbreviated New Drug Application for this product, which is indicated for the treatment of moderate to severe vasomotor symptoms and moderate to severe symptoms of vulvar and vaginal atrophy due to menopause; hypoestrogenism due to hypogonadism, castration, or primary ovarian failure; and the prevention of postmenopausal osteoporosis.
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FDA New Formulations
Zogenix, Inc. has announced that the FDA has approved a new formulation of Zohydro ER (hydrocodone bitartrate) Extended-Release Capsules, CII, with BeadTek. BeadTek is a formulation technology designed to provide abuse-deterrent properties without changing the release properties of hydrocodone when Zohydro ER is used as intended.
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0.9% Sodium Chloride Injection, USP, 250mL
Hospira, Inc. announced a voluntary nationwide recall of one lot of 0.9% Sodium Chloride Injection, USP, 250mL (NDC 0409-7983-02, Lot 44-002-JT, Expiry 1AUG2016) to the user level due to one confirmed customer report of particulate in a single unit. Hospira has identified the particulate as a human hair, sealed in the bag at the additive port area. To date, Hospira has not received reports of any adverse events associated with this issue for this lot. The affected lot was distributed nationwide from September 2014 through November 2014.
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Wallcur’s Practi-0.9% Sodium Chloride IV Bags
Wallcur’s Practi-0.9% sodium chloride IV bags supplied in 50mL, 250mL, 500mL, and 1000mL sizes and the Practi-0.9% sodium chloride 100mL IV solution bag with sterile distilled water are being recalled. All of Wallcur’s products are intended for training, simulation, and educational purposes only. Recently some of Wallcur’s training products were not used for their intended purpose. Specifically, despite the fact that the products are intended “for clinical simulation” only, there have been reports that these products have been used outside of their intended use and administered to patients. Because these products are not intended for human or animal administration, and are not sterile, administration of these products could result in adverse events. Shipping of this product began on May 22, 2014.
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Wyked Labs Dietary Supplement Products
Wyked Labs is voluntarily conducting a nationwide recall of all lot codes of the following products (collectively, the "Recalled Products") to the user/consumer level: Wyked Labs Ml-Alpha, Wyked Labs M14-Ment, Wyked Labs Halo-70, Wyked Labs 7-Ment Alpha, Wyked Labs Estrastain, Wyked Labs Swoll-250, Formexx Black (an Anabolic Science Labs product), and Slim X Lean (an Anabolic Science Labs product). This recall is being conducted due to the presence of ingredients that the FDA has stated do not meet the requirements of the Dietary Supplement Health and Education Act of 1994. Specifically, the Recalled Products are prohormone products or are otherwise adulterated.
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Bone Graft Substitutes Containing Recombinant Proteins or Synthetic Peptides
The FDA is aware of healthcare providers using bone graft substitutes containing recombinant proteins or synthetic peptides in patients under age 18. Reports of serious injuries, such as excess bone growth, fluid accumulation, inhibited bone healing, and swelling, have increased the FDA’s concern. While these types of events are similar to those seen in patients over age 18, they are of more concern in patients under age 18 because of their overall smaller size and because their bones are still growing. Any product that affects bone growth could have the potential to negatively impact skeletal development by altering normal bone formation and growth, especially if implanted near open growth plates.
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First System of Mobile Medical Apps
The FDA has allowed marketing of the first set of mobile medical apps that allow people with diabetes to automatically and securely share data from a continuous glucose monitor with other people in real-time using an Apple mobile device such as an iPhone.
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Pain Medicine Use During Pregnancy
The FDA is aware of and understands the concerns arising from recent reports questioning the safety of prescription and over-the-counter pain medicines when used during pregnancy. As a result, the FDA evaluated research studies published in the medical literature and determined they are too limited to make any recommendations based on these studies at this time. Because of this uncertainty, the use of pain medicines during pregnancy should be carefully considered. The FDA urges pregnant women to always discuss all medicines with their healthcare professionals before using them.
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