2013 New Drugs — The Year in Review
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elcome to this new column, the aim of which is to help members keep current on the FDA’s approval of new drugs, new indications, significant new dosage forms, and other important labeling changes. Efforts will be made to ensure that information appearing in this column is accurate and upto-date. As of this writing, the FDA has approved 26 new molecular entities or therapeutic biological products in 2013. By comparison, this lags slightly behind 2011 and 2012 during which 30 and 39 new drugs were approved, respectively. The table below briefly summarizes drugs approved. In addition to drugs that are used to treat or modify disease, the new agents have also been approved to aid in diagnostic imaging. These include Vizamyl™ (Flutemetamol F18) for visualizing beta-amyloid plaques in Alzheimer’s disease and dementia, Lymphoseek® (technetium Tc 99m tilmanocept) for lymphatic mapping in melanoma or breast cancer, and Dotarem® (gadoterate meglumine) for MRI of the brain and spinal tissue.
have reformulated several opioid/APAP combination products. Abbott introduced their Vicodin® product line with a reduced strength of 300mg of APAP and discontinued distribution of prior Vicodin® formulations. As a result, prescriptions written for Vicodin®, Vicodin ES® and Vicodin HP® can no longer be filled with a generic substitute. Otherwise, prescribers must order hydrocodone/APAP in a generically available strength (e.g. 5mg/325mg tablets). In other news, while groups ranging from the DEA, Congress, and national pharmacy organizations were weighing in on the merits of reclassifying all hydrocodone products from Schedule III to Schedule II, the FDA curiously approved Zohydro ER, the first hydrocodone-only drug in the US in a formulation that does not have abuse-limiting properties. Not surprisingly, attorneys general from 28 states have asked the FDA to reconsider its decision or to set a rigorous time line for Zohydro to be reformulated with abuse-deterrence. § _____________________________________________________________ Rodney Richmond, RPh, is Associate Professor, Pharmacy Practice, at Harding University College of Pharmacy in Searcy.
Two drugs made the Rx-to-OTC switch this year including Oxytrol® for Women (oxybutynin) transdermal patch for the treatment of overactive bladder, and Nasacort® Allergy 24HR (triamcinolone acetonide) for allergic rhinitis. Drugs that were withdrawn from the market in 2013 include Iclusig™ due to a risk of blood clots and narrowing of blood vessels, and Omontys® related to serious hypersensitivity reactions and deaths. A number of drugs were on schedule to lose patent protection in 2013. Out of approximately 120 drugs that were expected make the expiry list, the top ones in terms of total sales for which generic equivalents are now available include Cymbalta®, Lidoderm®, Maxalt®, Niaspan®, Reclast®, Temodar® (oral), Xeloda® and Zometa®. Others for which a generic is not yet available include Avonex®, Humalog®, Neupogen®, OxyContin®, Procrit® and Rebif®. Two other drugs made the list but have found new life through reformulation. Aciphex®, a generic of which is available for the 20mg tablet, now has two new strengths in a sprinkle formulation for children with GERD. Warner Chilcott received approval for Delzicol™ (mesalamine) delayed-release capsule as Asacol® reached the patent cliff. Finally, hydrocodone was one of the drugs capturing the most headlines in 2013. In order to meet a January 14, 2014 mandate that all APAPcontaining prescription products be limited to no more than 325mg per dosage unit, manufacturers AR•Rx
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THE ARKANSAS PHARMACIST
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