Mylan wins summary judgment pertaining to generic Copaxone
PITTSBURGH — Mylan has scored a victory in its efforts to make a generic version of a Teva drug for multiple sclerosis.
The U.S. District Court for the Southern District of New York denied Teva’s motion for a summary judgment finding no inequitable conduct in relation to Copaxone (glatiramer acetate).
Inequitable conduct is when the maker of a branded drug did not properly complete its application when filing for a patent for the drug. When a generic drug maker wishes to gain early entry for its version of the branded drug, it can file an approval application with the Food and Drug Administration that contains a paragraph IV certification, an assertion that the patent is invalid, enforceable or won’t be infringed, based on a finding of alleged inequitable conduct.
A trial in which Mylan will defend its assertion of inequitable conduct will begin on July 11.
J&J subsidiary recalls one lot of Risperdal, risperidone tablets
TITUSVILLE, N.J. — Johnson & Johnson is recalling 40,000 bottles of a drug used to treat schizophrenia due to consumer reports of the drug having a strange odor, the company said Friday.
J&J subsidiary Ortho-McNeil-Janssen Pharmaceuticals announced the voluntary recall of one lot of Risperdal (risperidone) tablets in the 3-mg strength and a lot of authorized generic risperidone tablets in the 2-mg strength made by Patriot Pharmaceuticals, also a J&J subsidiary.
The recall was started after reports of an “uncharacteristic odor” that is believed to be due to trace amounts of 2,4,6-tribromoanisole, or TBA, a chemical preservative sometimes applied to wood used in the construction of shipping pallets.
The company has recalled several prescription and over-the-counter drug products due to TBA contamination since 2009. Most recently, in May, J&J subsidiary Janssen-Cilag International recalled five lots of the HIV drug Prezista (darunavir) in Canada, the United Kingdom, Ireland, Germany and Austria. In January 2010, J&J instituted actions designed to reduce the potential of TBA contamination, including requiring suppliers to certify that they don’t use pallets made from chemically treated wood.
TBA is not considered toxic, but many people find its odor offensive, and there have been some reports of patients experiencing gastrointestinal problems after taking drugs with the odor.
FDA panel unanimously recommends approval of Eylea
TARRYTOWN, N.Y. — A panel of Food and Drug Administration experts has recommended approval of an investigational biotech drug made by Regeneron Pharmaceuticals for eye diseases.
Regeneron said Friday that the FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee unanimously recommended approval of Eylea (aflibercept) ophthalmic solution for the treatment of a form of age-related macular degeneration, also known as wet AMD. The disease causes abnormal growth of new blood vessels in the eye.
The FDA is not required to follow an advisory committee’s recommendation when deciding whether or not to approve a drug, but it usually does. The agency plans to make its decision on Aug. 20, according to Regeneron.