Branded

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.

RESEARCH TRIANGLE PARK, N.C. — A once-daily inhaler for chronic obstructive pulmonary disease has become available, the makers of the inhaler said Wednesday.

GlaxoSmithKline and Theravance announced the availability of Breo Ellipta (fluticasone furoate; vilanterol), for long-term maintenance treatment of airflow obstruction in patients with COPD, a term that encompasses chronic bronchitis and emphysema. The drug is not meant for treating acute bronchospasm or asthma, the companies said.

DEERFIELD, Ill. — The Food and Drug Administration has approved a drug made by Lundbeck for treating a form of epilepsy in children, the drug maker said.

Lundbeck announced the approval of Sabril (vigabatrin) as an add-on therapy for refractory complex partial seizures in children ages 10 years and older who have not responded adequately to other treatments, as long as the benefit of treatment outweighs the risk of vision loss. The drug was already approved for treating the same condition in adults in 2009.

NEW YORK — Generic drug maker Amneal Pharmaceuticals is seeking Food and Drug Administration approval for a gout drug, prompting a lawsuit from the maker of the branded version, according to published reports.

Law360 reported that Takeda Pharmaceuticals USA had sued Amneal in the U.S. District Court for the District of Delaware over the drug Colcrys (colchicine), used to treat gout and familial Mediterranean fever.

SILVER SPRING, Md. — The Food and Drug Administration has launched an online learning course aimed at healthcare professionals to educate them about potentially untruthful or misleading drug ads and promotional materials.

NEWARK, Calif. — Depomed has launched a new drug for breakthrough pain in cancer patients, the company said Monday.

The drug maker announced the launch of Lazanda (fentanyl) nasal spray, meant for treating adults who are taking opioid painkillers, but have become tolerant to them. The company also have launched a Signature Support Program designed to streamline patient access to the drug, including reimbursement and co-pay assistance. Other benefits of the program include prescription reminders and eligibility for one month's supply for free.

NEW YORK — A Food and Drug Administration expert panel has recommended approval for a drug made by Johnson & Johnson for treating hepatitis C, the company said.

J&J subsidiary Janssen Research & Development said the 19-member FDA Antiviral Drugs Advisory Committee voted unanimously to recommend approval for TMC435 (simeprevir), a 150-mg drug meant for administration once per day with the generic antiviral ribavirin and a biotech drug known as an interferon, for treating genotype 1 chronic hepatitis C.