Content about Organofluorides

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.

OXFORD, England  — 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.

PRINCETON, N.J. — 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.

Calcipotriene and betamethasone dipropionate ointment is a vitamin D analogue and corticosteroid combination product indicated for the topical treatment of psoriasis vulgaris in adults 18 years and older.

Psoriasis affects approximately 2% of the U.S. population. Plaque psoriasis is the most common form of the condition. 

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?

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. 

March 7, 2014

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

JERUSALEM — Teva Pharmaceutical Industries will launch the generic version of Xeloda (capecitabine) tablets, 150 mg and 500 mg, in the United States. The drug is used to treat cancers that have metastasized.

Xeloda tablets, 150 mg and 500 mg had annual sales in the United States of approximately $754 million as of December 2013, according to IMS.

 

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.

NEW YORK — 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. 

The trial is recruiting patients through more than 35 pharmacies and is expected to be completed by year-end.  

February 13, 2014

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

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

The drug is indicated for adult patients with chronic phase or accelerated phase chronic myeloid leukemia with resistance and/or intolerance to two or more tyrosine kinase inhibitors.

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.

DEERFIELD, Ill. — Takeda Pharmaceuticals U.S.A. and Lundbeck on Tuesday announced the availability of Brintellix (vortioxetine) — a once-daily oral antidepressant for treatment of major depressive disorder in adults — in pharmacies across the United States.

“MDD continues to be a challenging condition to manage, and we are proud to make Brintellix available as a new treatment option for people struggling with major depression,” said Douglas Cole, president of Takeda Pharmaceuticals U.S.A.

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%.

DUBLIN — 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%. 

Perrigo was awarded 180-days of generic drug exclusivity as it was the first company to submit an ANDA containing a paragraph IV certification. Perrigo had previously resolved litigation with the brand and has commenced shipment of the product.

January 10, 2014

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

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

Merck announced the approval of Isentress (raltegravir) for oral suspension, aimed at small children with HIV. The drug may be used by patients as young as four weeks, and the full line of formulations of Isentress now includes the orlal suspension, as well as chewable tablets and film--coated tablets. The company plans to launch the oral suspension in the third quarter of this year.

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.

FOSTER CITY, Calif. — 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.

Gilead said the FDA approved its single-pill regimen, Complera (emtricitabine; rilpivirine; tenofovir disoproxil fumarate) for use in adult patients who have suppressed their infections on stable antiretroviral regimens and are replacing their current regimens. The FDA originally approved the drug in 2011.

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.

CAMBRIDGE, Mass. — 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.

December 17, 2013

Greenstone has launched a version of a drug used to treat fungal infections, the company said.

PEAPACK, N.J. — Greenstone has launched a version of a drug used to treat fungal infections, the company said.

Greenstone, the generics subsidiary of Pfizer, announced the introduction of voriconazole for oral suspension, an authorized generic version of Pfizer's Vfend. Authorized generics are branded drugs sold at a discount under their generic names.

Greenstone is selling the drug in the 40 mg-per-milliliter strength. Vfend had sales of about $17.1 million during the 12-month period that ended in June, according to IMS Health.

 

December 4, 2013

The availability of new generic drugs for treating HIV will erode sales of HIV antiretroviral drugs into the next decade in developed countries, according to a new report.

BURLINGTON, Mass. — The availability of new generic drugs for treating HIV will erode sales of HIV antiretroviral drugs into the next decade in developed countries, according to a new report.

Healthcare market research firm Decision Resources released the report Wednesday, showing that sales of antiretroviral drugs in the United States, France, Germany, the United Kingdom, Spain, Italy and Japan would be $13.1 billion in 2022, down from 2012's $13.4 billion.

December 3, 2013

The Food and Drug Administration has given tentative approval to a generic drug for treating community-acquired pneumonia, agency records showed.

SILVER SPRING, Md. — The Food and Drug Administration has given tentative approval to a generic drug for treating community-acquired pneumonia, agency records showed.

According to the FDA's website, the agency granted the preliminary authorization for Roxane Labs' linezolid oral suspension in the 100-mg-per-5-mL strength.

December 3, 2013

The Food and Drug Administration has given tentative approval to a generic drug used to treat prostate disease, agency records showed.

SILVER SPRING, Md. — The Food and Drug Administration has given tentative approval to a generic drug used to treat prostate disease, agency records showed.

The FDA granted tentative approval to Roxane Labs' dutasteride capsules in the 0.5-mg strength. The drug is a generic version of GSK's Avodart, used to treat benign prostatic hyperplasia.

Tentative approval means that a drug meets the agency's conditions for approval, but can't receive final approval until Avodart loses its patent protection, which will occur in 2015.

 

November 22, 2013

The Food and Drug Administration has approved a drug made by Bayer HealthCare Pharmaceuticals for treating thyroid cancer, the agency said Friday.

SILVER SPRING, Md. – The Food and Drug Administration has approved a drug made by Bayer HealthCare Pharmaceuticals for treating thyroid cancer, the agency said Friday.

The FDA announced the approval of Nexavar (sorafenib) to treat late-stage differentiated thyroid cancer. The drug was already approved for kidney and liver cancers. The drug works by limiting cancer cell growth and replication by inhibiting proteins within the cells.

November 22, 2013

The Food and Drug Administration has granted regular approval to a new drug made by Pfizer for treating a form of lung cancer, the drug maker said.

NEW YORK — The Food and Drug Administration has granted regular approval to a new drug made by Pfizer for treating a form of lung cancer, the drug maker said.

November 4, 2013

The Food and Drug Administration has asked Ariad Pharmaceuticals to suspend marketing and sales of a chemotherapy drug for leukemia due to the risk of life-threatening side effects, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has asked Ariad Pharmaceuticals to suspend marketing and sales of a chemotherapy drug for leukemia due to the risk of life-threatening side effects, the agency said.

October 10, 2013

A subsidiary of Johnson & Johnson has acquired rights to an experimental drug for hepatitis C from GlaxoSmithKline.

TITUSVILLE, N.J. — A subsidiary of Johnson & Johnson has acquired rights to an experimental drug for hepatitis C from GlaxoSmithKline.

Janssen Pharmaceuticals announced that it had bought, for an undisclosed among, the drug GSK2336805 from GSK. The drug, which belongs to a class known as NS5a replication complex inhibitors, is currently in mid-stage development.

October 1, 2013

The Food and Drug Administration has approved a new drug developed by Takeda to treat major depressive disorder, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug developed by Takeda to treat major depressive disorder, the agency said.

The FDA announced the approval of Brintellix (vortioxetine) tablets for treating MDD in adults. The drug will be available in the 5-mg, 10-mg, 15-mg and 20-mg strengths.

September 16, 2013

The Food and Drug Administration has approved a generic chemotherapy pill for treating colorectal and breast cancers, the agency said Monday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a generic chemotherapy pill for treating colorectal and breast cancers, the agency said Monday.

The FDA announced the approval of Teva Pharmaceutical Industries' capecitabine tablets in the 150-mg and 500-mg strengths. The drug is used to treat cancers that have metastasized, meaning they've spread to other parts of the body.

The drug is a generic version of Xeloda, made by Roche division Genentech. According to IMS Health, Xeloda had sales of $706.2 million last year.

 

September 16, 2013

The Food and Drug Administration has approved a drug made by Sun Pharmaceutical Industries for ulcers, Sun said.

MUMBAI, India — The Food and Drug Administration has approved a drug made by Sun Pharmaceutical Industries for ulcers, Sun said.

Sun announced the approval of lansoprazole delayed-release capsules in the 15-mg and 30-mg strengths.

The drug is a generic version of Takeda's Prevacid delayed-release capsules, which are used for treatment lasting up to four weeks for healing and symptom relief of active duodenal ulcers.

Various versions of the drug have annual sales of about $430 million per year, according to Sun.

 

September 10, 2013

Teva Pharmaceutical Industries has introduced a generic version of an antibiotic drug kit, the company said.

NORTH WALES, Pa. — Teva Pharmaceutical Industries has introduced a generic version of an antibiotic drug kit, the company said.

Teva, through U.S. subsidiary Teva Pharmaceuticals, announced the introduction of 30-mg lansoprazole delayed-release capsules, 500-mg amoxicillin capsules and 500-mg clarithromycin tablets. The treatment is packaged in 14 cards with eight pills, designed for 14 days of treatment.

The treatment is a generic version of Takeda's Prevpac Kit.

 

August 13, 2013

The Food and Drug Administration approved Tivicay (dolutegravir), a new drug to treat HIV-1 infection that is manufactured by GlaxoSmithKline.

WASHINGTON — The U.S. Food and Drug Administration on Monday approved Tivicay (dolutegravir), a new drug to treat HIV-1 infection that is manufactured by GlaxoSmithKline.

Tivicay is an integrase strand transfer inhibitor that interferes with one of the enzymes necessary for HIV to multiply. It is a pill taken daily in combination with other antiretroviral drugs.

August 12, 2013

Perrigo Co. announced that it has received final approval from the Food and Drug Administration for its abbreviated new drug applications for fluocinolone acetonide scalp oil, 0.01%, the generic equivalent to Derma-Smoothe/FS Scalp Oil, and fluocinolone acetonide topical oil, 0.01%, the generic equivalent to Derma-Smoothe/FS Body Oil.

ALLEGAN, Mich. — Perrigo Co. today announced that it has received final approval from the U.S. Food and Drug Administration for its abbreviated new drug applications for fluocinolone acetonide scalp oil, 0.01%, the generic equivalent to Derma-Smoothe/FS Scalp Oil, and fluocinolone acetonide topical oil, 0.01%, the generic equivalent to Derma-Smoothe/FS Body Oil. Perrigo expects to begin shipments of both products next month.