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 17, 2014

To date, the Food and Drug Administration's Center for Drug Evaluation and Research has approved 35 novel new drugs in 2014, compared to 27 in 2013. 

December 17, 2014

The Food and Drug Administration on Wednesday approved Xtoro (finafloxacin otic suspension), a new drug that's used to treat acute otitis externa, commonly known as swimmer's ear. 

December 16, 2014

Novartis on Tuesday received approval from the Food and Drug Administration for Signifor long-acting release (pasireotide) for injectable suspension, for intramuscular use. 

 

December 12, 2014

DSN examines chain pharmacy, including in-depth coverage of pharmacy technology, biosimilars and generics, as well as a look at FDA reform and its potential impact on healthcare costs, in this multi-page report.

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 11, 2014

After a recent spike in the prices charged for some generic drugs led to outcries from pharmacists, patient advocates and federal lawmakers, a report issued last month suggests that drug costs can be controlled if the Food and Drug Administration changes the way it handles reviews and approvals.

 
December 9, 2014

The Generic Pharmaceutical Association agreed to support compromise automatic substitution legislation.

December 8, 2014

President Barack Obama signed into law in late November the Sunscreen Innovation Act.

December 5, 2014

The FDA issued a draft guidance that would provide generic companies a pathway to obtain samples of medicines requiring a Risk Evaluation and Mitigation Strategy (REMS) protocol for product testing.

December 4, 2014

Mylan on Thursday announced that its subsidiary, Mylan Labs, was granted tentative approval from the Food and Drug Administration for two dosages of abacavir/lamivudine tablets for oral suspension. 

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.

 

December 2, 2014

Perrigo on Tuesday announced that it has received final approval from the Food and Drug Administration on its abbreviated new drug application for diclofenac sodium topical solution 1.5% w/w.

December 1, 2014

The Food and Drug Administration recently issued draft guidance on key product tracing provisions of the Drug Supply Chain Security Act, which is expected to be implemented by the industry on Jan. 1, 2015. 

November 25, 2014

Mylan on Tuesday confirmed that it — along with several subsidiaries — has been sued by Baxter International, Baxter Healthcare Corp. and Baxter Healthcare S.A. in relation to the filing of an abbreviated new drug application for the generic version of Brevibloc. 

November 20, 2014

The Generic Pharmaceutical Association on Thursday emphasized the savings generic medicines bring to the table in light of rising brand prices. 

November 20, 2014

Purdue Pharma on Thursday announced that the Food and Drug Administration approved Hysingla ER (hydrocodone bitartrate) extended‐release tablets CII, a once‐daily, single‐entity medication formulated using Purdue’s proprietary extended‐release solid oral platform, Resistec.

November 19, 2014

The Food and Drug Administration opened a public docket and requested comments on proposed criteria for “first generic” abbreviated new drug application submissions.