Regulatory and Washington

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.

HAYWARD, Calif. — Generic drug maker Impax Labs is challenging the patent covering a drug used to treat high cholesterol, the company said Friday.

Impax said it had filed an approval application with the Food and Drug Administration for niacin and simvastatin extended-release tablets in the 1,000 mg/20 mg strength. The drug is a generic version of Abbott Labs’ Simcor.

ALEXANDRIA, Va. — More than ever, seniors who rely on Medicare need to carefully evaluate the dizzying array of prescription drug plan choices available to them, as the 2011 enrollment period for Medicare Part D drug benefit program goes into high gear, independent pharmacy leaders declared Tuesday.

BOSTON — Johnson & Johnson recalled lots of its Tylenol Cold Multi-Symptom liquid products due to insufficient labeling, the company said Wednesday.

The products are not being recalled due to reports of any adverse events associated with taking the product, the company added.

Earlier this week, the company recalled additional lots of millions of packages of Children's Benadryl and children's Motrin.

INDIANAPOLIS — Eli Lilly and Australian drug maker Acrux have received approval from the Food and Drug Administration for a testosterone replacement therapy for men, the two companies announced Tuesday.

The FDA approved Axiron (testosterone) topical solution as a treatment for men with various conditions that lead to deficiency of the hormone. The drug, a controlled substance, is designed for application under the arm.

HAYWARD, Calif. A generic drug maker confirmed a patent challenge for its version of a branded cholesterol drug that recently was submitted to the Food and Drug Administration for approval.

Impax said Daiichi Sankyo and Genzyme are seeking to block Impax's generic version of Welchol (colesevelam HCl) for oral suspension, in 3.75 g/packet and 1.875 g/packet strengths. The two drug makers filed suit for patent infringement against Impax in the U.S. District Court for the District of Delaware after being notified that the FDA accepted Impax's ANDA for the drug.

ALEXANDRIA, Va. In another bid to boost the standing of pharmacists in a changing healthcare system, the National Association of Chain Drug Stores urged a leading healthcare think-tank and advocacy group to adopt health quality standards that include a broader role for retail pharmacy professionals.

COLORADO SPRINGS, Colo. Several organizations representing retailers and consumer healthcare product manufacturers want Congress to reverse a provision in the healthcare-reform act that would prohibit the use of flexible spending accounts to purchase over-the-counter medicines without a prescription.