May 30, 2014

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.

May 29, 2014

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

May 29, 2014

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.

May 28, 2014

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.

May 28, 2014

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.

May 28, 2014

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

May 27, 2014

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.

May 27, 2014

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.

May 23, 2014

The Food and Drug Administration on Friday approved Dalvance (dalbavancin), a new antibacterial drug used to treat adults with acute bacterial skin and skin structure infections.

May 23, 2014

The Food and Drug Administration took action this week against websites that sell potentially dangerous, unapproved prescription drugs to U.S. consumers.

May 23, 2014

Teva Pharmaceutical on Friday announced that the Food and Drug Administration approved the use of QVAR (beclomethasone dipropionate HFA) with a dose counter for the treatment of asthma in patients 5 years of age and older.

May 21, 2014

Minnesota Gov. Mark Dayton last week signed a bill that will prohibit the use of the antibacterial ingredient triclosan in consumer hygiene products beginning Jan. 1, 2017, according to an Associated Press report published Monday.

May 21, 2014

Citing the need for a one-year transition period for states to implement the July average manufacturer price-based federal upper limits, or FULs, nine Senators are urging Department of Health and Human Services Secretary Kathleen Sebelius to consider the challenges that states will face when the final Medicaid AMP-based FULs are published.

May 21, 2014

Takeda Pharmaceutical on Tuesday announced that the Food and Drug Administration simultaneously approved a new biologic therapy, Entyvio (vedolizumab), for the treatment of adults with moderately to severely active ulcerative colitis and Crohn's disease.

May 20, 2014

The Centers for Medicare & Medicaid Services on Monday issued final regulations for the Medicare Advantage and prescription drug benefit (Part D) programs.

May 19, 2014

Responding to recent comments by Attorney General Eric Holder that "opiate addiction is an urgent — and growing — public health crisis," the National Community Pharmacists Association wrote to the Attorney General to offer recommendations on effectively combating the scourge of prescription drug abuse without forcing patients with legitimate medical issues to endure chronic pain, NCPA has announced.

May 16, 2014

The Food and Drug Administration on Thursday announced it required Sunovion Pharmaceuticals, manufacturer of the sleep drug Lunesta (eszopiclone), to change the drug label and lower the current recommended starting dose.

May 16, 2014

The National Association of Chain Drug Stores announced that Ben Bernanke, chairman of the Federal Reserve System from 2006 to 2014, will address the NACDS Total Store Expo during the morning Business Program on Aug. 24 at the Boston Convention and Exhibition Center in Boston.

May 16, 2014

Pfizer announced plans to submit a new drug application with the Food and Drug Administration for palbociclib, which is used for the first-line systemic treatment of post-menopausal women with advanced or metastatic breast cancer.

May 15, 2014

The Centers for Disease Control and Prevention on Wednesday released guidance advising practitioners to offer an HIV prevention pill to healthy individuals who are at high risk for an HIV infection, according to published reports.

May 15, 2014

The Generic Pharmaceutical Association lobbied for greater access to generics at this week’s meeting of the chief negotiators of the Trans-Pacific Partnership in Ho Chi Minh City, Vietnam, the association announced Wednesday.

May 15, 2014

The Retail Industry Leaders Association, along with several of America's most recognized retail brands, on Wednesday launched the Retail Cyber Intelligence Sharing Center.

May 15, 2014

Teva Pharmaceutical was denied in its suit to block approval of Mylan's and Sandoz' generic Copaxone, a multiple sclerosis, drug 10 days before the patent on the medication expires, according to a Bloomberg report published Thursday morning.

May 14, 2014

Actavis on Tuesday announced that it has received final approval from the Food and Drug Administration on its abbreviated new drug application for a generic version of Mallinckrodt's Exalgo (hydromorphone hydrochloride extended-release tablets 8 mg, 12 mg and 16 mg).