Ascend as you can read below is a subsidiary of Alkem, an India based drug manufacturer of mostly generic and over the counter products. Recently India drug companies have been under fire from the US FDA office and some plants have been closed. It’s kind of hard to tell exactly what the unapproved products are here and the US manufacturing office is located in New Jersey. I did look at the website and found generic Keflex on the list among other over the counter generic products such as Ibuprofen.
The FDA had performed an inspection in November of 2013 of the facility. The complaint alleges products are also misbranded and you can read below there are some pending FDA filings. BD
Ascend Laboratories is a subsidiary of Alkem Laboratories, one of the top seven pharmaceutical companies in India. Alkem is a vertically integrated organization with 15 manufacturing plants located throughout India, of which four are US FDA approved. The company has two state-of-the-art R&D centers located in Mumbai and Bangalore which employ over 500 scientists. The Mumbai R&D center is involved in the development of products some of which are Paragraph IV’s and first to file generics. The Bangalore R&D center is engaged in API process R&D, NCEs and Biosimilars. Currently, Alkem has 25 ANDAs pending FDA approval, five of which are Paragraph IV filings and two first to file ANDAs. In addition, the company plans to file 12-15 ANDAs per year and has in excess of 100 products under development.
Recently named by IMS as one of the fastest growing generic companies in the US, Ascend offers a broad line of high quality cost effective generic drugs which is sustained by a robust pipeline of additional products that will continue to fuel dynamic growth. Focused on Quality and Service, Ascend distinguishes itself in a congested marketplace by its firm commitment to two critical fundamentals: Uncompromising High Quality Products and Total Customer Satisfaction.
The U.S. Marshals on the request of the federal regulators and the U.S. Attorney for the Southern District of Ohio have seized more than $11,185,000 worth of unapproved drug that was marketed by Ascend Laboratories of Montvale, N.J. and distributed by Masters Pharmaceuticals, Inc of Cincinnati, Ohio.
The unapproved drugs seized include Pramoxine-HC Otic Drops, intended to treat infections of the external ear caused by microbes and also to control itching. The Marshals have also seized Hydrocortisone Acetate Suppositories 25 mg that is meant to treat inflamed haemorrhoids, ulcerative colitis and other inflammatory conditions. The list even included Urea Cream-39 percent, Urea Cream-40 percent and Urea Lotion 40 percent that is used to treat skin-thickening conditions like dermatitis and eczema.
None of the above mentioned products have been proven safe for use or effective for their intended use. The federal regulators caution that customers using these products should consult a health care professional about the continuing use.
A complaint has been filed by the FDA in the U.S. District Court for the Southern District of Ohio, alleging that the products are unapproved and misbranded drugs under the Federal Food, Drug and Cosmetic Act.
This complaint follows the November 2013 inspection held at Ascend Lab's that revealed the marketing of drug products without an FDA approved drug application.
This act of seizing products is consistent with the enforcement policy set in the FDA Marketed Unapproved Drugs Compliance Policy Guide which established that unapproved drug products first marketed after Sep 19, 2011 are subject to immediate enforcement action at any time without any notice.