NEW DRUG APPROVALS Zurampic for Hyperuricemia Associated With Gout The FDA has approved lesinurad (Zurampic, AstraZeneca) to treat high levels of uric acid in the blood (hyper­ uricemia) associated with gout. Lesinurad is to be used in combination with a xanthine oxidase inhibitor (XOI), a type of drug approved to reduce the pro­ duction of uric acid in the body. Lesinu­ rad helps the kidney excrete uric acid by inhibiting the function of transporter pro­ teins involved in uric acid reabsorption. The safety and efficacy of lesinurad (in combination with an XOI) were evaluated in three randomized, placebo-controlled studies involving 1,537 subjects who were treated for up to 12 months. The subjects treated with lesinurad and an XOI showed reduced serum uric acid levels compared with subjects given placebo. Source: FDA, December 22, 2015

Vistogard for Chemotherapy Overdose The FDA has cleared uridine triac­ etate (Vistogard, Wellstat Therapeutics) for the emergency treatment of adults and children who receive an overdose of the cancer treatment fluorouracil or capecitabine, or who develop certain severe or life-threatening toxicities within four days of receiving these can­ cer treatments. The efficacy and safety of uridine triace­ tate were studied in 135 adult and pediatric cancer patients who were treated in two separate trials and had received an over­ dose of fluorouracil or capecitabine, or who had early-onset, unusually severe or life-threatening toxicities within 96 hours after receiving fluorouracil (not due to an overdose). Of those who were treated with uridine for overdose, 97% were still alive at 30 days. Of those treated with uri­ dine for early-onset severe or life-threat­ ening toxicity, 89% were alive at 30 days.


P&T • ®

February 2016  •  Vol. 41 No. 2

In both studies, 33% of patients resumed chemotherapy in fewer than 30 days. Source: FDA, December 11, 2015

Uptravi for PAH Selexipag (Uptravi, Actelion Pharma­ ceuticals US) has been cleared for use in adults with pulmonary arterial hyperten­ sion (PAH), a chronic, progressive lung disease that can lead to death or the need for transplantation. Selexipag belongs to a class of drugs called oral IP prostacyclin receptor ago­ nists. The drug acts by relaxing muscles in the walls of blood vessels to reduce the elevated pressure in the vessels supplying blood to the lungs. The safety and efficacy of selexipag were established in a long-term clinical study of 1,156 participants with PAH. Selexipag was shown to be effective in reducing hospitalization for PAH and the risks of disease progression compared with placebo. The participants were exposed to selexipag for a median period of 1.4 years. Source: FDA, December 22, 2015

Basaglar for Type-2 Diabetes The FDA has approved Basaglar (insulin glargine injection, Eli Lilly), a long-­acting human insulin analogue, to improve glycemic control in adult and pediatric patients with type-1 diabetes mellitus and in adults with type-2 diabe­ tes mellitus. Basaglar is the first insulin product approved through an abbrevi­ ated approval pathway under the Fed­ eral Food, Drug, and Cosmetic Act. It received tentative approval from the FDA in August 2014 and has now been granted final approval. Source: FDA, December 16, 2015

Generic Approvals Olopatadine HCl Ophthalmic Solution Four companies have received FDA approval to market olopatadine hydro­

chloride ophthalmic solution USP, 0.1%: USV North America, Inc.; Apotex, Inc.; Novel Laboratories, Inc.; and Zach Sys­ tem, S.p.A. These are the first generic versions of Patanol Ophthalmic Solution (Alcon), a relatively selective H1 recep­ tor antagonist and inhibitor of histamine release from the mast cell for topical administration to the eyes. The medica­ tion is used to treat the signs and symp­ toms of allergic conjunctivitis. Sources: FDA, December 7, 2015, and Patanol prescribing information

Amikacin Sulfate Injection The FDA has approved the applica­ tion of Fresenius Kabi USA, LLC, to market amikacin sulfate injection USP, 250 mg/mL, a generic version of Ami­ kacin Sulfate Injection USP (Eurohealth International SARL). Amikacin injec­ tion is a semisynthetic aminoglycoside antibiotic that is active against a broad spectrum of gram-negative organisms, including Pseudomonas, and some grampositive organisms. Sources: FDA, December 9, 2015, and Amikacin injection prescribing information

Fesoterodine Fumarate ER Alkem Laboratories Ltd. has secured FDA approval to market fesoterodine fumarate extended-release tablets, 4 mg and 8 mg. This is the first generic ver­ sion of Toviaz Extended-Release Tab­ lets (Pfizer), a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. Sources: FDA, December 10, 2015, and Toviaz prescribing information

Levetiracetam Generic 250-mg, 750-mg, and 1,000-mg levetiracetam tablets can be marketed by Secan Pharmaceuticals, Inc., the FDA has ruled. The brand-name product, Keppra

(UCB Inc.), is indicated for adjunctive therapy for certain types of epileptic sei­ zures. Keppra had estimated U.S. sales of $271 million in 2015, according to GlobalData. Sources: FDA, December 16, 2015, and Keppra prescribing information

Busulfan Injection The FDA has approved the marketing of busulfan injection, 6 mg/mL (10 mL single-dose vial) by Pharmaforce, Inc.— the first generic formulation of Busul­ fex injection (Otsuka Pharmaceutical). Busulfex is an alkylating drug indicated for use in combination with cyclophos­ phamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelog­ enous leukemia. Sources: FDA, December 22, 2015, and Busulfex prescribing information

Neostigmine Methylsulfate Injection Neostigmine methylsulfate injection USP can be marketed in 5 mg/10 mL and 10 mg/10 mL strengths by Eurohealth International SARL. This marks the first generic version of Bloxiverz (Eclat Pharmaceuticals LLC), a cholinesterase inhibitor indicated for the reversal of the effects of nondepolarizing neuromuscular blocking agents after surgery. Sources: FDA, December 28, 2015, and Bloxiverz prescribing information

NEW INDICATIONS Xeomin for Upper Limb Spasticity IncobotulinumtoxinA (Xeomin, Merz North America) now has FDA approval for the treatment of upper limb spastic­ ity (ULS) in adults. In clinical studies, treatment with Xeomin in adults with ULS resulted in statistically and clinically sig­ nificant improvements in muscle tone. The FDA first approved Xeomin in August 2010 for the treatment of adults with cer­ vical dystonia and blepharospasm.

The approval of Xeomin for the treat­ ment of adults with ULS was based on results from a randomized, placebocontrolled trial that showed significant improvements in two coprimary outcome endpoints: muscle tone (Ashworth Scale score) and the Investigator’s Global Impression of Change of the Primary Target Clinical Pattern (PTCP) at week 4. Both parameters showed statistical signif­ icance compared with placebo (P 

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