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FDA Stops Company from Marketing Unapproved New Drugs

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On January 30, 2015, and at the request of the U.S. Food and Drug Administration (FDA), a federal judge granted a consent decree of permanent injunction against Laclede, a U.S.-based manufacturer in connection with the marketing of unapproved new drugs. The permanent injunction prohibits Laclede from selling and distributing unapproved new drugs or misbranded drugs and devices. According to FDA’s announcement, Laclede had a long history of violations with the FDA. In 2012, FDA inspectors found numerous violations of the Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals and other issues surrounding the marketing and sale of unapproved new drugs.…
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FDA Approval Required for Company Enjoined from Marketing Products

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On October 10, 2014, a federal judge from the U.S. District Court for the Southern District of Ohio sided with the U.S. Food & Drug Administration (“FDA”) and entered a consent decree for permanent injunction against Ascend Laboratories, LLC. As we previously reported, Ascend had been targeted in connection with the marketing and sale of certain products, deemed drugs by the FDA, without first obtaining formal FDA approval. As explained in FDA’s announcement of the injunction, the Company is now enjoined from marketing these products until they first secure FDA approval and post bond to recover the seized products. As…
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FDA Seizes Topical Creams Deemed Drugs

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On May 16, 2014, the U.S. Food and Drug Administration ("FDA"), with assistance by the U.S. Attorney for the Southern District of Ohio, seized unapproved drugs valued at more than $11 million, which were marked by Ascend Laboratories of Montvale, N.J. and held by Masters Pharmaceuticals, Inc. of Cincinnati, OH. The products seized by the FDA included those marketed for the treatment of inflamed hemorrhoids, colitis and other inflammatory conditions (Hydrocortisone Acetate Suppositories, 25 mg) and skin thickening conditions such as dermatitis and eczema (Urea Cream 39%, Urea Cream 40% and Urea Lotion 40%). The FDA announcement can be found…
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Supreme Court to Review Design Defect Case against Generic Drug Company

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On March 19, 2013, the U.S. Supreme Court will hear arguments in Mutual Pharmaceutical Company, Inc. v. Karen L. Bartlett. The defendant-appellant in the case, Mutual Pharmaceutical Company (“Mutual”) appealed from a decision of the U.S. Court of Appeals for the First Circuit, in Karen L. Bartlett v. Mutual Pharmaceutical Company, Inc., 678 F.3d 30 (1st Cir. 2012), where the Court found that the Federal, Food, Drug, and Cosmetic Act (“FDCA”) does not preclude a state law design defect claim against a generic drug manufacturer. You can find the documents in the case here. Mutual is a Pennsylvania company that…
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FDA Approves Bladder Control Drug for OTC Use, Highlighting Rx to OTC Switch

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On January 25, 2013, the U.S. Food and Drug Administration (“FDA”) announced the approval of the first women's bladder control product available without a doctor's prescription. In the past, all bladder control drugs were only available by prescription. This product, called Oxytol for Women, will be made available without a prescription for women aged 18 years and up only. Oxytol will remain available through a prescription only for men. The full story may be accessed here. Overactive bladder, a condition where the bladder squeezes too often or without warning, affects up to 33 million Americans annually, and the majority of…
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FDA Approves Drug for Treatment of Plague Through Animal Efficacy Rule

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On April 27, 2012, the U.S. Food and Drug Administration (“FDA”) approved Levaquin (levofloxacin), a drug used to treat those afflicted with plague. In addition to treating those with the deadly infection, Levaquin is also approved to reduce the risk of contracting plague after exposure to Yersinia pestis, the bacteria responsible for causing the disease. Although the FDA estimates that only 1,000 to 2,000 people worldwide contract the infection each year, the Agency is interested in expanding available treatment options for the disease based on its belief that it could potentially be used as a bioterrorism agent in the future.…
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FDA Approves Vivus Inc.’s Stendra to Treat Erectile Dysfunction

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On April 27, 2012, the U.S. Food and Drug Administration (“FDA”) approved the drug Stendra (avanafil), a drug used to treat erectile dysfunction (“ED”). Marketed by Vivus, Inc., Stendra is intended to be taken by men on an as-needed basis approximately thirty minutes prior to sexual activity. While several drugs used to treat ED are already on the market, including Viagra (sildenafil citrate) and Cialis (tadalafil), this recent approval marks the expansion of treatment options for those with ED. Under the FDA’s regulatory regime, drug sponsors must demonstrate that a drug is safe and effective for its intended use in…
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