06/02/2014 - 9:54am

Mylan announced on Monday that it has entered into a settlement and license agreement with Pfizer relating to Mylan's abbreviated new drug application filed with the U.S. Food and Drug Administration for celecoxib capsules in 50-mg, 100-mg, 200-mg and 400-mg strengths.

05/30/2014 - 10:21am

Teva Pharmaceutical Industries announced on Friday that the U.S. District Court for the Northern District of West Virginia has denied a motion filed by Mylan and issued an opinion and order affirming a decision by the FDA under which Teva should receive sole 180-day “first-to-file” exclusivity for generic Celebrex (celecoxib) 100-, 200- and 400-mg capsules.

05/29/2014 - 8:04am

Depomed on Wednesday announced that the Food and Drug Administration has accepted for filing a new drug application from Mallinckrodt for MNK-155.

05/29/2014 - 7:29am

Louisiana became the sixth state to prohibit minors from purchasing over-the-counter cough medicines containing dextromethorphan as Gov. Bobby Jindal signed HB 514 into law.

05/28/2014 - 11:18am

Actavis on Tuesday confirmed that it has filed an abbreviated new drug application with the Food and Drug Administration seeking approval to market saxagliptin hydrochloride tablets, 2.5 mg and 5 mg.

05/28/2014 - 9:36am

As a key Congressional committee is set to consider legislation to help identify solutions for prescription drug abuse while preserving patients’ legitimate access to needed medications, the National Association of Chain Drug Stores has sent a letter to the bipartisan leadership of the House Energy and Commerce committees’ Health subcommittee affirming support for this effort, NACDS has announced.

05/28/2014 - 8:59am

Sanofi and Eli Lilly and Co. on Wednesday announced an agreement to pursue regulatory approval of nonprescription Cialis (tadalafil).

05/27/2014 - 4:07pm

Aurobindo Pharma on May 15 gained approval to produce a generic version of olanzapine orally disintegrating tablets in 5-mg, 10-mg, 15-mg and 20-mg strengths.

05/27/2014 - 10:59am

The mere phrase “malpractice lawsuit” has struck fear in the hearts of many healthcare providers, and for good reason.

A study published in the New England Journal of Medicine in 2011 estimated that by age 65 years, most physicians (75% in low-risk specialties and 99% in high-risk specialties) will have faced a malpractice claim.