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The Food and Drug Administration recently issued draft guidance on key product tracing provisions of the Drug Supply Chain Security Act, which is expected to be implemented by the industry on Jan. 1, 2015.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

 

November 18, 2014

DSN examines chain pharmacy, including in-depth coverage of pharmacy technology, biosimilars and generics, as well as a look at the impact of the Hatch-Waxman act and Q&A's with industry leaders, in this multi-page report.

November 17, 2014

CRN on Monday submitted comments to the Food and Drug Administration advocating a new qualified health claim for EPA+DHA and blood-pressure reduction. 

November 17, 2014

Genzyme, a Sanofi company, on Friday announced that the Food and Drug Administration approved Lemtrada (alemtuzumab) for the treatment of patients with relapsing forms of multiple sclerosis. 

November 17, 2014

DSN spoke with Neas in late October to mark the 30th anniversary of the landmark Drug Price Competition and Patent Term Restoration Act — better known as the Hatch-Waxman Act. 

November 17, 2014

Thirty years ago, Democratic and Republican members of Congress hammered out a rare and prescient bipartisan compromise bill that transformed the pharmaceutical landscape forever and unleashed the modern generic drug industry. That law, known as the Hatch-Waxman Act, has proven to be one of the most far-reaching and impactful pieces of legislation ever to shape the American healthcare system.

November 14, 2014

The Council for Responsible Nutrition has launched a tool that compiles Food and Drug Administration warning letters sent to dietary supplement companies into a searchable database.

November 13, 2014

 Janssen Pharmaceuticals announced that the Food and Drug Administration approved the company's supplemental new drug application for the once-monthly Invega Sustenna (paliperidone palmitate), an antipsychotic used to treat schizoaffective disorder as either monotherapy or adjunctive therapy. 

November 11, 2014

Dr. Reddy's Labs received approval from the Food and Drug Administration for a generic version of Roche Holding's antiviral medication Valcyte, according to a Reuters report

November 7, 2014

Janssen Therapeutics announced earlier this week that the Food and Drug Administration approved Olysio (simeprevir), a hepatitis C virus NS3/4A protease inhibitor, in combination with sofosbuvir as an all-oral, interferon- and ribavirin-free treatment option for genotype 1 chronic hepatitis C (CHC) infection in adult patients as part of a combination antiviral treatment regimen. 

November 4, 2014

Rogaine brand on Tuesday announced the launch of Women's Rogaine 5% Minoxidil topical aerosol, the first and only once-daily treatment approved by the Food and Drug Administration for the treatment of female pattern hair loss, according to the brand. 

November 3, 2014

Protein Sciences Corp. last week announced that the Food and Drug Administration approved Flublok influenza vaccine for all adults ages 18 years and older.

November 3, 2014

The RAND Corp. projected that the introduction of biosimilar drugs in the United States will reduce direct spending on biologics by $44.2 billion from 2014 to 2024.

 

October 30, 2014

AstraZeneca on Thursday announced that the Food and Drug Administration approved Xigduo XR (dapagliflozin and metformin hydrochloride extended-release), a once-daily drug for the treatment of adults with Type 2 diabetes. 

October 28, 2014

he Food and Drug Administration last week announced approval for Obizur for the treatment of bleeding episodes in adults with acquired hemophilia A. 

October 22, 2014

Pfizer last week announced that the Food and Drug Administration approved a revised label for Embeda (morphine sulfate and naltrexone hydrochloride) extended-release capsules, for oral use, CII, to include abuse-deterrence studies. 

 

October 22, 2014

The Food and Drug Administration last week announced plans to survey pharmacists and patients about their experiences resulting from changes in generic drug pill appearance.