Government obtains permanent injunction against Deltex
SILVER SPRING, Md. — A permanent injunction was granted to the federal government Tuesday against a contract manufacturer and distributor of prescription and over-the-counter products, as well as two of its executives.
In a complaint filed by the Department of Justice in the U.S. District Court for the Southern District of Texas, officials said that Deltex Pharmaceuticals and its president and VP, Kabir Ahmed and Mohidur Khan, violated the Federal Food, Drug, and Cosmetic Act by failing to obtain required approval from the Food and Drug Administration for its prescription drugs, as well as failing to comply with FDA regulations governing OTC drug products and current good manufacturing practice requirements.
In 2008, the FDA said it issued a warning letter to the company over its manufacturing of unapproved drugs and for deviations from cGMP requirements. Under the injunction, Deltex must comply with all federal requirements before continuing the manufacturing and distributing of its prescription and OTC products.
"This injunction shows that the FDA will seek enforcement action against companies that are identified as being in violation of our manufacturing and drug approval requirements," said Dara Corrigan, FDA’s associate commissioner for regulatory affairs.
Essential oil may reduce PMS symptoms
NEW YORK — A new study published in BioMed Central’s open-access journal, Reproductive Health, found that essential fatty acids may reduce premenstrual syndrome symptoms among women.
In a randomized, controlled trial of 120 women, Edilberto Rocha Filho worked with a team of researchers from the Federal University of Pernambuco, Brazil, administered 1 or 2 grams of essential oil. Women who were given capsules containing 2 grams of a combination of gamma linolenic acid, oleic acid, linoleic acid, other polyunsaturated acids and vitamin E reported significantly eased PMS symptoms at both three and six months after they began the treatment.
"The negative effect of PMS on a woman’s routine activities and quality of life may be significant, in addition to the repercussions on economic costs resulting predominantly from a reduction in productivity. Essential oil capsules can now be said to show much promise as a treatment," the researchers noted, adding that "the administration of the dietary supplement did not result in any changes in the total cholesterol in the patients evaluated."
B. Braun’s wound management gel available for OTC use
BETHLEHEM, Pa. — B. Braun has launched its Prontosan wound management gel — a product used in the healthcare setting for cleaning wounds, as well as moistening and lubricating absorbent wound dressings — for over-the-counter use.
The ready-to-use gel contains PHMB and betaine, the surfactant for the cleansing and moistening of wounds. Its nontoxic and biocompatible formula also offers excellent skin tolerance, the company said.
"Effective wound care management no longer needs to be limited to within healthcare facility walls," said Mike Kelly, director of marketing, infection control products for B. Braun. "The 510(k) clearance [which occurred in November 2010] for OTC use of Prontosan wound management gel advances B. Braun’s commitment to infection prevention, helping to provide solutions that positively impact patients’ care in a physician’s office, acute care setting or in a patient’s home."