FDA approves cardiovascular drug
MORRISTOWN, N.J. — The Food and Drug Administration has approved a generic drug for treating blood pressure and chest pain. Actavis announced the approval of diltiazem hydrochloride extended-release capsules. The drug is a generic version of Valeant’s Tiazac. The branded drug and its generic equivalents had sales of about $76.3 million in 2011, according to IMS Health.
GPhA appoints CVS Caremark public policy director to head policy shop
WASHINGTON — An executive from CVS Caremark will guide policy for a generic drug industry trade association. The Generic Pharmaceutical Association said that it had appointed CVS Caremark senior director of public policy Christine Simmon to run its policy shop as SVP policy and strategic alliances, effective Oct. 24. Christine Simmon previously worked for the GPhA as VP policy, public affairs and development from 2002 to 2006.
“We are delighted to welcome Christine back to our professional team,” GPhA president and CEO Ralph Neas said. “Her vast experience working with legislators, regulatory agencies and industry leaders on key healthcare issues will serve our industry well. She will play a leading role in our mission to show that safe, effective and affordable generic medicines are a critical part of the solution to controlling costs and lowering the nation’s healthcare bill.”
Simmon also will help expand the GPhA’s partnerships with other industry, consumer and public policy organizations, the group said.
Ranbaxy launches authorized
generic for dry mouth
PRINCETON, N.J. — Ranbaxy Labs has launched an authorized generic drug for treating dry mouth associated with an autoimmune disorder, the company said.
The India-based generic drug maker announced the launch of cevimeline hydrochloride in the 30-mg strength under an agreement with parent company Daiichi Sankyo. The drug is used in patients with Sjogren’s syndrome, which affects the moisture- producing glands.
Daiichi Sankyo markets the drug under the name Evoxac. The drug had sales of $62.4 million during the 12-month period ended in June 2011, according to IMS Health.
An authorized generic is a branded drug marketed under its generic name at a lowered price. Apotex is marketing the generic version of the drug.
Mylan settles respiratory drug suit
PITTSBURGH — Mylan has settled a patent infringement suit over a drug used to treat respiratory diseases, Mylan said. The generic drug maker said it resolved a patent litigation suit filed by Shionogi and Cima Labs over prednisolone sodium phosphate orally disintegrating tablets, a generic version of Orapred ODT. Mylan is hoping to market its generic version of the drug in the 10-mg, 15-mg and 30-mg strengths. The drug is used to treat asthma and certain allergic conditions.
Under the settlement, Mylan will be able to launch its product starting in April 2014. The company said it was likely the first company to file a regulatory approval application containing a Paragraph IV certification, a legal assertion that the patent covering the branded drug is invalid, unenforceable or not at risk of being infringed.
Orapred ODT had sales of $33.1 million during the 12-month period ended in June, according to IMS Health.