PHARMACY

ANI acquires generic product from Teva

BY Ryan Chavis

BAUDETTE, Minn. — ANI Pharmaceuticals acquired the approved abbreviated new drug application for flecainide acetate tablets USP in 50-mg, 100-mg and 150-mg dosage strengths. The antiarrhythmic drug was previously marketed by Teva Pharmaceuticals. The market for the drug was $39 million in 2014 according to data from IMS Health.  

"This acquisition further expands our near-term generic pipeline. We intend to re-launch the product within the next 12 months. We are excited that this transaction further extends the ANI-Teva relationship,” said Arthur Przybyl, president and CEO of ANI Pharmaceuticals.

ANI has 47 generic drug products currently in development, which address a total annual market size of $3 billion, according to IMS Health data. 

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FDA publishes bio-equivalence guidance documents

BY Michael Johnsen

SILVER SPRING, Md. — The Food and Drug Administration recently announced the release of new documents meant to make it easier for generic manufacturers to introduce competition to 38 existing drug products, including Stendra, Belviq, Kalydeco and Brilinta, according to a blog published Monday by the Regulatory Affairs Professionals Society
 
According to the blog, the bioequivalence guidance documents released by FDA last week explain how each generic drug company can test its products to ensure approval. 
 
"Each document contains a list of recommended studies (typically at least two), the characteristics of each study, the standard for bioequivalence that must be met by each generic product and potential waivers a generic company may apply for," noted blog author Alexander Gaffney.
 

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Cardinal Health awarded HDMA’s 2015 Distribution Management Award

BY Michael Johnsen

ARLINGTON, Va. ― Cardinal Health was named the winner of HDMA’s 2015 Distribution Management Award for EZ Cart and EZ Tote, two solutions that streamline the restocking process for their pharmacy customers. 
 
“We know that mail-order pharmacies want to be more efficient when verifying product receipts against the manifest and restocking shelves, and our EZ Cart and EZ Tote solutions deliver on that need,” said William Taylor, marketing manager, Cardinal Health. “We’re honored to receive this HDMA award because it recognizes the impact these innovative solutions have on our customers. By streamlining receiving and replenishing processes, these solutions save our customers time and money, while freeing up their time so they can focus on filling prescriptions and counseling patients.”  
 
The EZ Cart system was devised to help large, mail-order pharmacies improve efficiency and reduce costs. The system structures inbound orders by location within the pharmacy. Cardinal Health picks, packs and ships totes by purchase order number. Knowing that totes must be moved from the receiving dock to the warehouse location, Cardinal Health designed totes to fit into a preconfigured cart, significantly reducing the time it takes for customers to restock products on their shelves. On average, EZ Cart led to a four-step reduction in the receiving and replenishing process for mail-order pharmacies.
 
Following the success of EZ Cart, the EZ Tote system was created for smaller pharmacies and involves inbound orders being picked at the distribution center and sorted within the tote, using compartmentalized dividers. Products are neatly organized by NDC when received at the pharmacy, and organized by name to match against the shipping manifest, resulting in an efficient receiving and replenishment process. According to Cardinal Health, by using EZ Tote, a pharmacy that receives 50 totes per day on average will have a time-savings reduction of 45 minutes. 
 
“HDMA members are constantly reevaluating their processes and operations to benefit the ultimate customer ― the patient,” said Perry Fri, EVP industry relations, membership and education. “We are pleased to honor Cardinal Health for demonstrating an overwhelming commitment to boosting the efficiency of the supply chain with their innovative restocking solution.” 
 
In addition to Cardinal Health, two supply chain partnerships were named Merit Finalists, including AmerisourceBergen, Walgreens and Alliance Boots for their long-term strategic partnership and H. D. Smith and Legisym, for their mobile-enabled Controlled Substance Ordering System.  
 

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