Generics

PARSIPPANY, N.J. — The Food and Drug Administration has approved a generic opioid painkiller made by Actavis, the drug maker said.

The creation of a clear approval pathway for biosimilar drugs remains a daunting task for the Food and Drug Administration, despite the fact that it's prescribed by law through the Patient Protection and Affordable Care Act. But when those lower-priced, generic versions of some staggeringly expensive bioengineered medicines do finally come to market, they're likely to have a profound effect on the nation's outlays for specialty pharmaceuticals.

MUMBAI, India — The Food and Drug Administration has approved a generic diabetes drug made by Sun Pharmaceutical Industries, Sun said Friday.

The Indian generic drug maker announced the approval of repaglinide tablets in the 1-mg and 2-mg strengths, which are used in combination with diet and exercise to improve blood-sugar control in patients with Type 2 diabetes.

PARSIPPANY, N.J. — Actavis is looking to become the first to market a generic drug for epilepsy, the company said Friday.

Actavis announced that it had filed with the Food and Drug Administration for lacosamide tablets in the 50-mg, 100-mg, 150-mg and 200-mg strengths. The drug is a generic version of UBC's Vimpat and is used to treat partial-onset seizures in epilepsy patients aged 17 and older.

MEMPHIS, Tenn. — Fred's Super Dollar on Thursday posted $187.7 million in sales for the five weeks ended July 6, up 3% as compared to the year-ago period. Comparable-store sales for the month increased 4.5%.

NEW YORK — Legislation introduced in the Senate would coordinate efforts at various levels of government and industry to reduce the growing problem of prescription drug abuse.

The bill, the Combatting Prescription Drug Abuse Act, was introduced by Sen. Barbara Boxer, D-Calif., drawing praise from pharmacy groups. Among other things, the bill could create a 30-member Combatting Prescription Drug Abuse Commission that would include people from health care and law enforcement, including people from the pharmacy industry.

PARSIPPANY, N.J. — Actavis and Warner Chilcott on Thursday announced that they have each received a request for additional information from the Federal Trade Commission in connection with Actavis' pending acquisition of Warner Chilcott. The information request was issued under notification requirements of the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended.  

PITTSBURGH — Mylan is challenging a patent on a drug used to treat ulcerative proctitis, the generic drug maker said Thursday.

Mylan said it had filed a regulatory approval application with the Food and Drug Administration for melamine rectal suppositories in the 1,000-mg strength. The drug is a generic version of Canasa, which had sales of about $153 million during the 12-month period that ended in March, according to IMS Health.