Generics

HAYWARD, Calif., and FORT COLLINS, Colo.  — Impax Labs and Tolmar announced that the Food and Drug Administration has given final approval to Tolmar's generic version of Solaraze (diclofenac sodium) gel in the 3% strength.

MASON, Ohio — A personalized medicine company said a new study justifies clinical use of pharmacogenomic testing to help predict patients' response to psychiatric medications and improve treatment outcomes.

SILVER SPRING, Md. — The Food and Drug Administration is using long-term strategies to address drug shortages when they appear and requiring manufacturers to notify the agency if a shortage is at risk of happening, under a new plan announced Thursday.

PITTSBURGH — Mylan experienced a slight dip in sales in its third quarter, due primarily to fluctuating currency values, the generic drug maker said Thursday.

JERUSALEM — Teva Pharmaceutical Industries' president and CEO has stepped down, the Israeli drug maker said.

Teva announced the resignation of Jeremy Levin and that the board of directors had named EVP and CFO Eyal Desheh as interim president and CEO. Desheh has worked at Teva for more than 12 years, serving as CFO for the last five.

DUBLIN — Actavis hopes to become the first company to market a generic version of a drug used to treat acne in adolescents and adults, the company said.

The drug maker announced that it had filed a regulatory approval application with the Food and Drug Administration for a generic version of Acanya (clindamycin phosphate; benzoyl peroxide) gel in the 1.2%/2.5% strength. Acanya is made by Valeant Pharmaceuticals International and Dow Pharmaceutical Sciences and is used to treat acne vulgaris in patients aged 12 and older.

DUBLIN — Actavis had sales of $2.01 billion in third quarter 2013, a 57% increase over the same period last year, the drug maker said Tuesday.

Profits for the quarter were $65.5 million, down from $76.7 million in third quarter 2012. The quarter's results exclude figures from Ireland-based Warner Chilcott, which Actavis acquired at the beginning of the month.

GURGAON, India — Ranbaxy Labs had global sales of $447.6 million in third quarter 2013, compared with $434.6 million in third quarter 2012, the Indian drug maker said Tuesday.

Sales from generics were $208.4 million, while branded and OTC drugs had sales of $239.3 million North American sales were $143.24 million including $128.6 million in the United States, lower than in Q3 2012 due to a large contribution last year from new generic drugs.