February 17, 2015

The Food and Drug Administration last week issued five draft documents related to drug compounding and repackaging that will help entities comply with important public health provisions.

January 30, 2015

Diplomat Pharmacy announced Thursday that the Food and Drug Administration has approved an expanded indication of Imbruvica (ibrutinib) for the treatment of Waldenström’s macroglobulinemia (WM).

January 20, 2015

The Food and Drug Administration has expanded the age indication for Natroba (spinosad) topical suspension 0.9% to include children 6 months of age and older who have head lice infestations (pediculosis capitis).

January 16, 2015

Kathleen "Cook" Uhl on Thursday was named director of the Food and Drug Administration's Office of Generic Drugs.

 

January 14, 2015

The Food and Drug Administration established the Office of Pharmaceutical Quality, a new division tasked with improving quality control at pharmaceutical manufacturing facilities.

 

December 30, 2014

Vertex Pharmaceuticals has announced that the Food and Drug Administration approved a supplemental new drug application for the use of Kalydeco (ivacaftor) in people with cystic fibrosis ages 6 years and older who have the R117H mutation in the cystic fibrosis transmembrane conductance regulator gene.

December 23, 2014

Specialty pharmacy Diplomat Pharmacy has announced that it will stock Viekira Pak (ombitasvir/paritaprevir/ritonavir tablets; dasabuvir tablets), which was approved Dec. 19 by the Food and Drug Administration.

December 23, 2014

Teva Pharmaceutical today announced that the Food and Drug Administration has approved Granix (tbo-filgrastim) Injection for self-administration by patients and caregivers. With the approval of this additional administration option, physicians will soon have the flexibility to prescribe Granix for either in-office or at home use.

December 22, 2014

The Food and Drug Administration granted accelerated approval to Lynparza (olaparib), a new drug treatment for women with advanced ovarian cancer associated with defective BRCA genes, as detected by an FDA-approved test.

December 22, 2014

The Food and Drug Administration has granted accelerated approval to Opdivo (nivolumab), a new treatment for patients with unresectable (cannot be removed by surgery) or metastatic (advanced) melanoma who no longer respond to other drugs.

December 22, 2014

The Food and Drug Administration has approved Viekira Pak (ombitasvir, paritaprevir and ritonavir tablets co-packaged with dasabuvir tablets) to treat patients with chronic hepatitis C virus (HCV) genotype 1 infection, including those with a type of advanced liver disease called cirrhosis.

December 22, 2014

The Food and Drug Administration has approved Zerbaxa (ceftolozane/tazobactam), a new antibacterial drug product, to treat adults with complicated intra-abdominal infections and complicated urinary tract infections.

December 19, 2014

Teva Pharmaceutical announced that the Food and Drug Administration approved QNasl (beclomethasone dipropionate) 40 mcg for the treatment of nasal symptoms associated with allergic rhinitis in children ages 4 years to 11 years.

December 17, 2014

Ipsen Biopharmaceuticals on Tuesday announced that Somatuline Depot (lanreotide) Injection 120 mg (referred to as Somatuline) was approved by the U.S. Food and Drug Administration for the treatment of gastroenteropancreatic neuroendocrine tumors.

December 12, 2014

Sanofi Pasteur announced that the FDA approved the supplemental biologics license application for Fluzone Intradermal Quadrivalent vaccine.

December 11, 2014

The Food and Drug Administration on Wednesday approved Gardasil 9 for the prevention of certain diseases caused by nine types of human papillomavirus.

December 3, 2014

The Food and Drug Administration published a final rule that sets standards for how information about using medicines during pregnancy and breastfeeding is presented in the labeling of prescription drugs and biological products.

 

August 25, 2014

Pharmaceutical company Iroko announced today that a new version its anti-inflammatory drug Zorvolex had been approved by the Food and Drug Administration.

August 19, 2014

The Food and Drug Administration has approved Mylan Institutional’s application for its dexmedetomidine hydrochloride injection, the company announced Tuesday. 

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 2, 2014

On June 25, the U.S. Department of Justice, at the request of the Food and Drug Administration, filed a complaint for permanent injunction in the U.S. District Court for the Central District of California against Laclede of Rancho Dominguez, Calif., and its president, Michael Pellico.

June 26, 2014

The Food and Drug Administration has issued a warning that certain OTC topical acne products may cause rare but serious and potentially life-threatening allergic reactions or severe irritation.

June 2, 2014

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.

March 25, 2014

The Drug Store News Group, the leading provider of news, information and clinical education for the retail pharmacy industry, has launched the new microsite, Drugstorenews.com/pain-management, to help bring attention to another tragic side of the prescription drug abuse story — the millions of Americans who live in chronic pain that may be unable to access the medications they need thanks to proposed changes in regulatory policy.