August 14, 2014

The Food and Drug Administration has announced approval for Belsomra (suvorexant) tablets, which are used to treat insomnia.

August 12, 2014

Sanofi on Tuesday announced that it has launched an authorized generic version of Eloxatin (oxaliplatin injection) through Winthrop U.S., the company’s generics division. 

August 11, 2014

Mylan announced the launch of capecitabine tablets USP in 150-mg and 500-mg dosage strengths, a generic version of Xeloda tablets from Genentech.

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 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 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 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.

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.

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 6, 2014

In a related transaction to Tuesday morning's acquisition of Merck's OTC portfolio, Bayer also agreed to enter into a strategic pharma collaboration in the area of cardiovascular diseases with a focus on sGC modulation.

April 30, 2014

The Food and Drug Administration on Tuesday granted approval to Zykadia (ceritinib) for patients with a specific type of late-stage (metastatic) non-small cell lung cancer (NSCLC).

April 28, 2014

Mylan last week announced that it filed suit against the Food and Drug Administration, challenging the agency's decision regarding generic drug marketing exclusivity on celecoxib capsules, the generic equivalent of Pfizer's Celebrex.

April 17, 2014

Teva Pharmaceutical announced that its U.S. subsidiary has entered into a settlement with Pfizer related to Teva's generic version of Celebrex (celecoxib) 50-, 100-, 200- and 400-mg capsules in the United States.

April 15, 2014

Prosonix, a speciality pharmaceutical company developing a portfolio of inhaled respiratory medicines by Design, on Tuesday announced that it has entered into a global licensing agreement with Mylan for its leading inhaled respiratory products, PSX1001 and PSX1050.

April 2, 2014

Sandoz on Tuesday announced the U.S. market introduction of its calcipotriene and betamethasone dipropionate ointment, the first generic version of Leo Pharma’s Taclonex Ointment.

March 7, 2014

It's finally happening. Pfizer has placed the ball at the line of scrimmage. And based on the X's and O's to come out of its Lipitor OTC actual-use study, Pfizer will be making its run with its eye on the ultimate prize — a successful Rx-to-OTC switch of a statin.

Only this time, the Food and Drug Administration may not be as quick to sack Pfizer's switch attempt. With the advances and pervasion of health technology in the self-care space by way of smartphones and tablets; with the evolution of the pharmacist as a healthcare professional able to practice at the top of their license; and with the adoption of diagnostic tests like a cholesterol panel that can be physically administered in the pharmacy, consumers may finally get it right when self-selecting a statin.

Because it's the consumer actual-use studies that have scuttled just about every statin switch attempt in the past. In the last switch of Mevacor, FDA advisory panelists determined the statin was safe enough for the self-care space. And it was effective. It's just that the consumers who would be right for an OTC statin didn't appropriately self-select. And if they can't appropriately self-select, what's the point, really?

March 7, 2014

Teva Pharmaceutical Industries will launch the generic version of Xeloda (capecitabine) tablets, 150 mg and 500 mg, in the United States.

March 3, 2014

Pfizer is recruiting for a 1,200-patient actual use study to measure whether or not patients can appropriately self-select treating high cholesterol with the statin Lipitor, the Wall Street Journal reported on Sunday.

February 13, 2014

Teva Pharmaceutical Industries announced that the Food and Drug Administration has granted full approval of Synribo (omacetaxine mepesuccinate) for injection.

January 22, 2014

Takeda Pharmaceuticals and Lundbeck announced the availability of Brintellix (vortioxetine), a once-daily oral antidepressant for treatment of major depressive disorder in adults.

January 15, 2014

Perrigo on Tuesday announced that it has received final approval for its abbreviated new drug application for fluocinonide cream 0.1%, the generic equivalent to prescription-only Vanos Cream 0.1%.

January 10, 2014

The Food and Drug Administraiton has approved a liquid formulation of an HIV drug made by Merck, the company said.

December 27, 2013

The Food and Drug Administration has approved an HIV pill made by Gilead Sciences for patients who are switching from other therapy regimens, the company said.

December 23, 2013

The Food and Drug Administration has approved revisions to the labeling of a leukemia drug made by Ariad Pharmaceuticals that allow the company to resume selling it, the company said.