Bayer’s regorafenib granted fast-track review
WAYNE, N.J. — The Food and Drug Administration will expedite its review of an investigational drug made by Bayer HealthCare Pharmaceuticals for treating tumors of the gastrointestinal tract, the company said Tuesday.
Bayer announced that the FDA had granted fast-track designation to BAY 73-4506 (regorafenib), designed to treat patients with gastrointestinal stromal tumors whose disease has spread to other parts of the body or whose tumors can’t be removed through surgery, and whose disease has progressed despite treatment with other drugs. The FDA grants fast-track designation to aid the development and expedite review of drugs that treat serious diseases and fill an unmet medical need.
“There is an unmet medical need for this specific patient population,” Bayer HealthCare Pharmaceuticals head of global development Kemal Malik said. “This milestone is an important step in the overall development of regorafenib.”
V23 introduces medication disposal solution
BECKLEY, W.Va. — A West Virginia company has released a medication disposal product designed to allow environmentally safe disposal of unused medicines and render the medicines undesirable to potential drug abusers.
V23, a subsidiary of Vaught, announced the launch of Element MDS. The product consists of a tamper-evident bottle into which unused drugs can be placed and then mixed with a special powder and tap water, which turn them into an undesirable, solid gelatinous substance.
Most of the Element MDS’ marketing so far has focused on hospices, but it sells for $9.99, and a spokesman for the company told Drug Store News that it could potentially be sold in retail pharmacies and used in the home as well.
Cypress launches generic Elestat
MADISON, Miss. — Cypress Pharmaceuticals has launched a generic version of an eye care drug made by Boehringer Ingelheim and marketed by Allergan, the company said.
Cypress announced the launch of epinastine hydrochloride ophthalmic solution 0.05%, a generic version of Elestat; BI owns the trademark to Elestat and licenses rights to the drug to Allergan. Elestat is used to relieve itching of the eyes resulting from allergic conjunctivitis.
Cypress’ approval application for the drug included a paragraph IV certification, a legal assertion that the branded drug’s patents are invalid, unenforceable or won’t be infringed by a generic version.