FDA targets unapproved cough-cold, allergy drugs with Unapproved Drugs Initiative
SILVER SPRING, Md. — The Food and Drug Administration has taken action against makers of prescription drugs for cough-cold and allergies that don’t have regulatory approval, the agency said Wednesday.
The action is part of the agency’s Unapproved Drugs Initiative, which seeks to remove from the market drugs that have not received approval. In many cases, the drugs were marketed before the FDA adopted its current regulatory standards.
The products include a wide range of drugs with active ingredients ranging from guaifenesin to dextromethorphan to pseudoephedrine hydrochloride, which also appear in a number of FDA-approved prescription and over-the-counter products. The agency said that many healthcare providers didn’t know the drugs didn’t have FDA approval because they lacked any labels indicating they didn’t.
“Removing these unapproved products from the market will reduce potential risks to consumers,” FDA Office of Compliance director Deborah Autor said. “There are many FDA-approved prescription products, as well as appropriately marketed over-the-counter products, available to treat cough-cold and allergy symptoms; so we expect little or no negative impact on consumers from the removal of these unapproved products.”
Perrigo announces re-inspection of Allegan, Mich., plant
ALLEGAN, Mich. — Following the warning letter it received last April, Perrigo announced that the Food and Drug Administration has arrived at the company’s Allegan, Mich.-based facility for re-inspection.
The re-inspection of the plant follows an initial inspection that occurred between Nov. 17, 2009, and Jan. 14, 2010, in which the FDA "identified significant violations of current good manufacturing practice regulations for finished pharmaceuticals," the regulatory agency said in its letter last year, noting certain production problems, including an equipment failure that shredded metal shavings into bottles on a production line of 200-mg ibuprofen tablets.
Insight acquires e.p.t.
LANGHORNE, Pa. — Insight Pharmaceuticals is strengthening its portfolio of over-the-counter products with its acquisition of a popular at-home pregnancy test.
Insight said that e.p.t. will join other Insight brands, including Sucrets, Nix, Bonine and Gentle Naturals. As the first FDA-approved, commercially available home pregnancy test, e.p.t. aligns with Insight’s strategy to build "a significant portfolio of OTC and personal care products," Insight’s CEO Gary Downing said.
Insight noted that e.p.t will continue to be available through existing retail channels and will be marketed under Insight’s portfolio of brands.