The FDA sent U.S. Marshals in to seize more than $11 million worth of drugs from Ascend Laboratories, a subsidiary of Indian drugmaker Alkem Laboratories, saying the company never got them approved. The products include skin creams, ear drops and a treatment for inflamed hemorrhoids.
The products were taken in Ohio, where they were being distributed by Masters Pharmaceuticals, but they were being marketed by Montvale, NJ-based Ascend Laboratories. Ascend is a unit of Alkem Laboratories, a generic drugmaker that claims to be among the top 7 drugmakers in India. The Ascend website says Alkem has 15 manufacturing sites in India, four of which it says are FDA-approved.
The FDA said seized products included pramoxine-HC otic drops for treating ear infections; hydrocortisone acetate suppositories for treating inflamed hemorrhoids, ulcerative colitis and other inflammatory conditions; and urea cream and urea lotion for treating conditions like dermatitis and eczema. It put the total value of the products at $11,185,000. The FDA said that the drugmaker was told last November after an inspection at Ascend Laboratories that the drugs needed to be run through the agency's approval process. Friday's action was taken after it filed a complaint against the company in the U.S. District Court for the Southern District of Ohio. The company did not respond to a request for comment.
The FDA has taken similar steps against other drugmakers when they continue to sell products it believes are unapproved or don't meet certain standards. In 2012, for example, it had marshals seize Other-Sonic Generic Ultrasound Transmission Gel manufactured by Pharmaceutical Innovations that was tied to infections at a neonatal intensive care unit. In the same year, it had marshals quarantine products at Global Biotechnologies of Portland, ME, because it said claims it made that products can cure diseases violated federal law.
The latest action also takes place as the agency has stepped up oversight of the Indian drugmaking industry, which accounts for about 40% of the generic and over-the-counter products used in the U.S., second only to Canada. Because of its prominence in the U.S. market, the agency is devoting more attention to drugmakers there and has upped its inspection presence in the country. Wockhardt and Ranbaxy Laboratories, India's largest drugmaker, both have had two plants each banned in the last year because of quality and analytics issues. The regulatory problems at Ranbaxy, which last year pleaded guilty to 7 felony charges and agreed to pay $500 million to settle ongoing problems, has led owner Daiichi Sankyo to decide to sell the company. Sun Pharma, which also had a plant banned by the FDA in recent months, will acquire Ranbaxy in an all-stock deal valued at about $3.2 billion.
- here's the release