PHARMACY

FDA approves generic versions of Cymbalta

BY Alaric DeArment

SILVER SPRING, Md. – The Food and Drug Administration has approved the first generic versions of a drug used to treat depression and other conditions, the agency said Wednesday.

The FDA announced the approval of generic duloxetine delayed-release capsules manufactured by Aurobindo Pharma, Dr. Reddy’s Labs, Lupin, Sun Pharmaceutical Industries, Teva Pharmaceutical Industries and Torrent Pharmaceuticals.

The drug is a generic version of Eli Lilly’s Cymbalta. Cymbalta had sales of $4.7 billion in 2012, making it the fifth top-selling drug that year, according to IMS Health. In addition to depression, Cymbalta is used to treat pain resulting from diabetic peripheral neuropathy, fibromyalgia and other causes. Most of Lilly’s patents on Cymbalta expire this year or within the next couple of years, though its patent covering the use of the drug for fibromyalgia won’t expire until 2019, according to FDA records. 

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Warner Chilcott settles with Zydus over generic Asacol HD

BY Alaric DeArment

DUBLIN — A subsidiary of Actavis has reached a settlement with a generic drug maker that will allow the launch of a generic version of a treatment for ulcerative colitis in 2015.

Actavis said its Warner Chilcott subsidiary had settled with Zydus Pharmaceuticals USA and Cadila Healthcare over Zydus’ generic version of Asacol HD (mesalamine) delayed-release tablets.

Financial terms of the deal were not disclosed, but Warner Chilcott will give Zydus a royalty-bearing license to market its generic product starting in November 2015, pending its approval by the Food and Drug Administration. If Zydus does not receive FDA approval, it will be allowed to market an authorized generic version of the drug starting in July 2016.

Asacol HD had sales of $122 million during the quarter that ended on June 30, according to Warner Chilcott.

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FDA seeks to limit use of antibiotics in animal feed to curb rise of resistant bacteria

BY Alaric DeArment

SILVER SPRING, Md. – The Food and Drug Administration is planning to limit the use of antimicrobials in food animals in an effort to stem the rise of antibiotic-resistant bacteria, the agency said Wednesday.

Some antimicrobials have historically been added to the feed and drinking water of livestock in order to allow them to gain more weight with less food, but some of them are also used to treat infections in humans. This has fed worries among health experts that the practice may play a role in the growing trend of bacteria that are immune to antibiotics, which also is a reason why experts advise people to take antibiotics only when medically necessary.

The FDA’s plan focuses on antibiotics that are used both for human infections and as feed and water additives for food animals. In a guidance, the agency is laying out a plan for animal drug companies to voluntarily revise their product labeling so that it doesn’t encourage their use in meat production and is asking the companies to notify the agency of their intent to sign onto the strategy within three months.

"Implementing this strategy is an important step forward in addressing antimicrobial resistance," FDA deputy commissioner for foods and veterinary medicine Michael Taylor said. "Based on our outreach, we have every reason to believe that animal pharmaceutical companies will support us in this effort."

The agency also has issued a proposed rule to update existing regulations relating to veterinary feed directive, or VFD drugs, and expand the oversight of veterinarians when they’re used.

"This action promotes the judicious use of important antimicrobials to protect public health while ensuring that sick and at-risk animals receive the therapy they need," FDA Center for Veterinary Medicine director Bernadette Dunham said. "We realize that these steps represent changes for veterinarians and animal producers, and we have been working — and will continue to work — to make this transition as seamless as possible."

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