July 30, 2014

Perrigo on Wednesday announced that it has filed an abbreviated new drug application with the Food and Drug Administration for desoximetasone topical spray 0.25%. The company also has notified Taro Pharmaceuticals U.S.A., the owner of the reference listed drug, of the filing.

July 29, 2014

Legislation that would speed up and streamline the Food and Drug Administration’s approval process for new sunscreen ingredients passed the House on Monday, according to published reports.

July 29, 2014

The use of FDA drug safety programs to prevent generic competition is costing the American health care system and patients $5.4 billion in annual pharmaceutical spending.

July 29, 2014

A bipartisan bill that calls for a collaborative, coordinated approach to curbing prescription drug abuse and safeguarding patients is headed to the U.S. House for a vote.

July 29, 2014

The Food and Drug Administration may have more generic drug applications than it does personnel to process them, according to a Wall Street Journal report published Tuesday.

July 28, 2014

The Food and Drug Administration on Monday expanded the approved use of Imbruvica (ibrutinib) to treat patients with chronic lymphocytic leukemia who carry a deletion in chromosome 17.

July 28, 2014

The Food and Drug Administration has accepted a license application by Sandoz, Novartis' generics company, for a potential generic biologic drug, the company announced Monday.

July 25, 2014

The National Association of Specialty Pharmacy  and the Specialty Pharmacy Association of America announced the merger of the two organizations, creating the largest professional and trade association focused on the unique needs in specialty pharmacy. 



July 24, 2014

The Consumer Healthcare Products Association celebrated the first International Self-Care Day event in the United States.

July 24, 2014

The Food and Drug Administration approved Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended-release tablets), a long-acting opioid analgesic.

July 23, 2014

Health on the National Mall, co-sponsored by Cardinal Health and the National Community Pharmacists Association, showcased the expanding role pharmacists are playing in improving patient care.

July 23, 2014

Mylan on Wednesday announced that U.S. District Court for the district of New Jersey granted a temporary restraining order against Apotex Inc. and Apotex Corp. relating to Paroxetine CR.

July 23, 2014

Three states are suing the makers of 5-Hour Energy for false claims, according to published reports. Oregon, Washington and Vermont have all filed suit and more states are expected to join in.

July 23, 2014

The Food and Drug Administration on Wednesday announced approval for Zydelig (idelalisib) to treat patients with chronic lymphocytic leukemia, relapsed follicular B-cell non-Hodgkin lymphoma and relapsed small lymphocytic lymphoma.

July 22, 2014

The Food and Drug Administration has granted tentative approval to Teva Pharmaceutical for abacavir sulfate and lamivudine tablets, according to agency records.

July 21, 2014

AbbVie has finalized a deal for Dublin-based specialty pharmaceuticals company Shire for $54.7 billion.

July 21, 2014

Illinois Gov. Pat Quinn signed a bill Monday that opens up medical marijuana to treat symptoms of epilepsy in adults and children.

July 21, 2014

The Food and Drug Administration’s Center for Drug Evaluation and Research is providing an update to key leadership positions within the Office of Generic Drugs, the agency announced.

July 18, 2014

The Food and Drug Administration on Thursday announced the approval of Ruconest, a recombinant C1-Esterase inhibitor product for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema.

July 18, 2014

FedEx on Thursday was indicted as a co-conspirator for illegally distributing pharmaceuticals sourced from a pair of rogue online pharmacies.

 

July 17, 2014

There is “something brewing in Congress” these days, NACDS president and CEO Steve Anderson wrote in a July 16 newsletter to NACDS chain members.

July 17, 2014

Mylan on Thursday announced that the U.S. District Court for the district of New Jersey granted its motion for a permanent injunction against GlaxoSmithKline in relation to paroxetine CR, the generic version of GSK's Paxil CR.

July 15, 2014

Former Republican Speaker of the House J. Dennis Hastert last week wrote an editorial for the Washington Times supporting the use of such tamper-resistant pseudoephedrine products as Acura Pharmaceuticals' Nexafed and Westport Pharmaceuticals' Zephrex-D.

July 15, 2014

Current programs to dispose of unused medicines in the home are sufficient, argued representatives of industry in appealing a provision put into place by a San Francisco-area county that would place the burden of recapturing these medicines on the manufacturer.