Content about Food and Drug Administration

INDIANAPOLIS The Food and Drug Administration declined to approve a long-anticipated diabetes drug made by Eli Lilly and two other companies, the companies said Tuesday.

Lilly, Amylin Pharmaceuticals and Alkermes said the FDA issued them a complete response letter for their application for Bydureon (exenatide), a once-weekly version of the Type 2 diabetes drug Byetta. A complete response letter means that the FDA has completed review of a regulatory application, but issues remain that preclude approval.

MORRISTOWN, N.J. The Food and Drug Administration has approved a drug for treating insomnia made by Actavis, the generic drug maker said Monday.

Actavis announced the approval of zolpidem tartrate extended-release tablets in the 6.25-mg strength. The company has begun shipping the drug.

The drug is a generic version of Sanofi-Aventis’ Ambien CR, which had sales of around $129 million during the 12-month period ended in June, according to IMS Health.

PRINCETON, N.J. The Food and Drug Administration has approved an additional use for a hepatitis drug.

Bristol-Myers Squibb announced Monday the approval of Baraclude (entecavir) as a treatment for chronic hepatitis B in adults with decompensated liver disease. The drug already is approved for adults with evidence of active viral replication.

SAN MATEO, Calif. A company that develops drugs for pain is hoping to get approval of one of its drugs for a pain condition associated with HIV.

PITTSBURGH The Food and Drug Administration has approved two generic drugs by Mylan for treating hypertension, Mylan said Friday.

The company announced the approval of losartan potassium and hydrochlorothiazide tablets in the 50/12.5-mg and 100/25-mg strengths, and losartan potassium tablets in the 25-mg, 50-mg and 100-mg strengths, generic versions of Merck’s Hyzaar and Cozaar, respectively. Mylan began marketing its version of Hyzaar in the 100/12.5-mg strength in April.

MORRISTOWN, N.J. The Food and Drug Administration has approved a Watson Pharmaceuticals generic drug for treating high blood pressure, Watson said Friday.

The company announced the FDA approval of amlodipine besylate and benazepril capsules in the 5/20-mg, 10/20-mg, 2.5/10-mg and 5/10-mg strengths.

The drug is a generic version of Novartis’ Lotrel. Branded and generic versions of the drug had sales of around $1.05 billion during the 12-month period ended in June, according to IMS Health.

BALTIMORE, Md. Lupin Pharmaceuticals received regulatory approval last week for its generic antihypertensive agents, the drug maker said.

Lupin was granted final approval for hydrochlorothiazide-losartan potassium and losartan potassium, the generic versions of Merck's Hyzaar and Cozaar.

Hyzaar and Cozaar had combined annual sales of approximately $1.6 billion in the United States, based on IMS sales data for the 12 months ended in June.

PALO ALTO, Calif. The Food and Drug Administration has turned down an application from a company seeking approval for a drug to treat fibromyalgia.

Jazz Pharmaceuticals announced Monday that the FDA had given it a complete response letter for the drug JZP-6 (sodium oxybate), citing a need for additional clinical studies and issues concerning the appropriate patient population, ensuring safe use, a proposed risk evaluation and mitigation strategy, and others.

BALTIMORE —Remote management of diabetes increasingly is becoming a reality to day with WellDoc’s Diabetes-Manager system, which recently received 510(k) clearance from the Food and Drug Administration.