Generics

SCHAUMBURG, Ill. — The Food and Drug Administration has approved a generic chemotherapy drug made by Sagent Pharmaceuticals, Sagent said Thursday.

The FDA approved topotecan hydrochloride for injection, a version of GlaxoSmithKline’s Hycamtin. The U.S. market for injectable topotecan was around $158 million in 2010, according to IMS Health.

CHADDS FORD, Pa. — Endo Pharmaceuticals has finished its acquisition of Qualitest Pharmaceuticals for $1.2 billion, Endo said Wednesday.

Endo had agreed to buy Qualitest, a privately owned manufacturer of generic drugs, on Dec. 28.

GURGAON, India, and PRINCETON, N.J. — Ranbaxy Pharmaceuticals has received final approval for its generic Alzheimer's drug from the Food and Drug Administration, giving the drug maker 180 days of market exclusivity.

Ranbaxy Pharmaceuticals, a subsidiary of Ranbaxy Labs, will manufacture and market donepezil hydrochloride tablets, a generic version of Aricept, in the 5-mg and 10-mg strength in the United States.

HAYWARD, Calif. — A generic version of a drug indicated to treat attention deficit hyperactivity disorder has hit a roadblock.

ALLEGAN, Mich. — The Food and Drug Administration has granted market exclusivity for a generic version of a medication designed to treat indoor and outdoor allergies.

Perrigo said Monday that its licensor and supplier Synthon received regulatory approval for levocetirizine tablets, a generic version of UCB/Sepracor's Xyzal, which is marketed in the United States by Sanofi-Aventis.

The levocetirizine tablet is the only approved generic product having a label containing all indications, Perrigo said.

NEW YORK — Recent public perception that the Food and Drug Administration had not been doing its job — ensuring that Americans' approved medical devices and medicines are relatively safe — may be impeding fast approval processes, according to a new PricewaterhouseCoopers report published Tuesday.

The report, “Improving America’s Health V,” determined that the FDA’s renewed vigor for enforcing regulations may be straining the working relationship between regulator and the industry being regulated.

DEERFIELD, Ill. — Walgreens' chief medical officer will discuss the evidence-based medicine design and impact of a diabetes management program delivered by pharmacists at both workplace and community pharmacies during an upcoming conference, the drug store chain said.

MUMBAI, India — A generic drug maker announced that the Food and Drug Administration has granted tentative approval for its version of a popular antidepressant.

Sun Pharmaceutical Industries said the FDA approved its duloxetine hydrochloride delayed-release capsules in 20-mg, 30-mg and 60-mg strengths. The capsules are a generic version of Eli Lilly's Cymbalta, which is indicated to treat major depressive disorder, generalized anxiety disorder, diabetic peripheral neuropathic pain, fibromyalgia and chronic musculoskeletal pain.