Content about Pyrimidines

January 21, 2014

Vivus and Auxilium Pharmaceuticals announced that the Food and Drug Administration has accepted a supplemental application that proposes to revise the Stendra (avanafil) prescribing information with efficacy and safety information from Study TA-501, entitled "A Randomized, Double-Blind, Placebo-Controlled Evaluation of Avanafil for On-Demand Treatment of Men with Erectile Dysfunction."

MOUNTAIN VIEW, Calif. — Vivus and Auxilium Pharmaceuticals on Tuesday announced that the Food and Drug Administration has accepted a supplemental application that proposes to revise the Stendra (avanafil) prescribing information with efficacy and safety information from Study TA-501, entitled "A Randomized, Double-Blind, Placebo-Controlled Evaluation of Avanafil for On-Demand Treatment of Men with Erectile Dysfunction." 

The PDUFA date for the supplemental filing is Sept. 20, 2014.

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 3, 2013

Inergetics and the Podiatree Co. on Tuesday launched Intrinsix, a podiatry-exclusive nerve health support supplement enriched with calcium and vitamin D.

NEWARK, N.J. — Inergetics and the Podiatree Co. on Tuesday launched Intrinsix, a podiatry-exclusive nerve health support supplement enriched with calcium and vitamin D.

Developed alongside pharmacist, Robert Graci, Inergetics has created a unique formula to support healthy nerve function and specifically help diabetic patients who experience nerve-related symptoms in their extremities, which include tingling, pain, burning and loss of sensation, the company stated. 

October 9, 2013

The Food and Drug Administration today approved Adempas, also known as riociguat, to treat adults with two forms of pulmonary hypertension, which is caused by abnormally high blood pressure in the arteries of the lungs.

SILVER SPRING, Md. — The Food and Drug Administration today approved Adempas, also known as riociguat, to treat adults with two forms of pulmonary hypertension, which is caused by abnormally high blood pressure in the arteries of the lungs.

August 12, 2013

This year, generic drugs account for 83% of all drugs dispensed in the United States, and that figure is set to get even larger over the next few years. That was among the takeaways from IMS Health VP industry relations Doug Long’s presentation Sunday morning.

LAS VEGAS — This year, generic drugs account for 83% of all drugs dispensed in the United States, and that figure is set to get even larger over the next few years. That was among the takeaways from IMS Health VP industry relations Doug Long’s presentation Sunday morning.

July 9, 2013

Mylan has received tentative approval for a generic version of a cholesterol drug made by AstraZeneca, according to Food and Drug Administration records.

SILVER SPRING, Md. — Mylan has received tentative approval for a generic version of a cholesterol drug made by AstraZeneca, according to Food and Drug Administration records.

The FDA gave the tentative approval to Mylan's rosuvastatin calcium tablets in the 5 mg, 10 mg, 20 mg and 40 mg strengths. The drug is a generic version of AstraZeneca's Crestor, which had sales of $5.1 billion in 2012, according to IMS Health.

April 2, 2013

A ruling by India's high court means cheaper generic versions of a cancer drug will remain available in developing countries, according to published reports.

NEW YORK — A ruling by India's high court means cheaper generic versions of a cancer drug will remain available in developing countries, according to published reports.

The New York Times reported that the Indian Supreme Court ruled drug companies there could keep making generic versions of Swiss drug maker Novartis' leukemia medication Gleevec (imatinib). According to the Times, generic versions of Gleevec in India cost about $2,500 per year, compared with $70,000 per year for the branded version.

March 25, 2013

Generic drug maker Actavis has reached a deal with AstraZeneca that will allow it to launch a version of a drug used to treat cholesterol in three years, Actavis said Monday.

PARSIPPANY, N.J. — Generic drug maker Actavis has reached a deal with AstraZeneca that will allow it to launch a version of a drug used to treat cholesterol in three years, Actavis said Monday.

Under a deal to settle a patent-infringement lawsuit, Actavis will be allowed to launch its generic version of Crestor (rosuvastatin calcium) tablets in the 5-mg, 10-mg, 20-mg and 40-mg strengths 67 days before July 8, 2016, when the drug's market exclusivity for use in children expires, at a fee of 39% of net sales to AstraZeneca.

January 25, 2013

The Food and Drug Administration has approved a Novartis drug for treating leukemia in children.

SILVER SPRING, Md. — The Food and Drug Administration has approved a Novartis drug for treating leukemia in children.

The FDA said Friday that it approved Gleevec (imatinib) for treating children newly diagnosed with Philadelphia chromosome-positive acute lymphoblastic leukemia, also known as Ph+ ALL.

December 14, 2012

A federal court has ruled in favor of AstraZeneca in a case regarding a cholesterol drug, the company said.

WILMINGTON, Del. — A federal court has ruled in favor of AstraZeneca in a case regarding a cholesterol drug, the company said.

AstraZeneca said the Court of Appeals for the Federal Circuit upheld a decision by the U.S. District Court for the District of Delaware ruling that a patent covering the drug Crestor (rosuvastatin calcium) was valid and enforceable. The patent, which expires in 2016, covers the active ingredient of Crestor.

October 26, 2012

The Food and Drug Administration has approved what it called the second new drug in two months for a form of leukemia, the agency said Friday.

SILVER SPRING, Md. — The Food and Drug Administration has approved what it called the second new drug in two months for a form of leukemia, the agency said Friday.

The FDA announced the approval of Teva Pharmaceutical Industries' Synribo (omacetaxine mepesuccinate) for chronic myelogenous leukemia, or CML, a disease that the National Institutes of Health expects will be diagnosed in more than 5,400 people this year. The drug is intended for patients whose disease has progressed after treatment with at least two drugs of a class used to treat the disease.

June 28, 2012

Mylan has launched a generic drug for treating thiamine deficiency, the company said Thursday.

PITTSBURGH — Mylan has launched a generic drug for treating thiamine deficiency, the company said Thursday.

The generic drug maker announced the launch of thiamine hydrochloride injection in the 100-mg-per-mL strength, packaged in 25-vial packs of 200-mg-per-2-mL multiple-dose vials.

The drug had sales of about $18.6 million during the 12-month period ended in March, according to IMS Health. Mylan said it would ship the drug immediately.

June 21, 2012

Manufacturers of sunscreen now will have six additional months to meet the new labeling and testing requirements as imposed by the Food and Drug Administration, according to an announcement from the Federal Register.

INDUSTRY NEWS — Manufacturers of sunscreen now will have six additional months to meet the new labeling and testing requirements as imposed by the Food and Drug Administration, according to an announcement from the Federal Register. The FDA ordered the changes last summer but gave manufacturers one year — until this June — to get the revised bottles on the shelf. The FDA now is delaying the compliance dates of the 2011 final rule by six months, to Dec. 17 for products with sales of $25,000 or more; and until Dec.

March 27, 2012

The Food and Drug Administration has approved a drug made by Johnson & Johnson for treating HIV in children.

TITUSVILLE, N.J. — The Food and Drug Administration has approved a drug made by Johnson & Johnson for treating HIV in children.

J&J's Janssen Therapeutics division announced Tuesday the FDA approval of Intelence (etravirine) in patients ages 6 years to younger than 18 years with HIV-1 who have taken other therapies but whose infection has become resistant to treatment. The drug already was approved for adults.

March 2, 2012

Perrigo announced that it has initiated market launch and made its first shipments of minoxidil 5% foam, which is a generic version of Rogaine 5% foam hair regrowth treatment, to its retail and wholesale customers. Minoxidil 5% foam is marketed under store- or own-label brands.

ALLEGAN, Mich. — Perrigo announced that it has initiated market launch and made its first shipments of minoxidil 5% foam, which is a generic version of Rogaine 5% foam hair regrowth treatment, to its retail and wholesale customers. Minoxidil 5% foam is marketed under store- or own-label brands.

November 21, 2011

A subsidiary of Aceto Corp. has launched two generic drugs for treating infectious diseases, the company said Monday.

PORT WASHINGTON, N.Y. — A subsidiary of Aceto Corp. has launched two generic drugs for treating infectious diseases, the company said Monday.

Aceto said its Rising Pharmaceuticals subsidiary launched flucytosine capsules, a version of Valeant Pharmaceuticals International's Ancobon, used to treat serious infections; and chloroquine phosphate tablets, a generic version of Sanofi's malaria drug Aralen. The drugs' branded versions had sales of $20 million during the 12-month period ended in June, Aceto said.

May 3, 2011

The Food and Drug Administration has approved a generic version of Rogaine made by Perrigo, the drug maker said.

ALLEGAN, Mich. — The Food and Drug Administration has approved a generic version of Rogaine made by Perrigo, the drug maker said.

Perrigo announced the FDA approval of over-the-counter minoxidil foam, a generic version of men’s Rogaine foam.

Stiefel Research Australia, part of GlaxoSmithKline, sued Perrigo for patent infringement when the latter submitted its regulatory approval application. Under a settlement between the companies reached in February, Perrigo can launch its generic version of men’s Rogaine foam in March 2012.

February 1, 2011

A new weapon to battle hair loss has arrived.

SKILLMAN, N.J. — A new weapon to battle hair loss has arrived.

New Rogaine unscented topical foam quickly penetrates into the scalp to revitalize hair follicles that have become dormant and stimulate hair growth, the company said.

The new Rogaine product will be available nationwide this month and on RogaineDirect.com ($29.99 for one-month supply and $49.99 for a three-month supply).

January 3, 2011

The Food and Drug Administration has approved an update to the label of a Johnson & Johnson drug for HIV, the company said Monday.

TITUSVILLE, N.J. — The Food and Drug Administration has approved an update to the label of a Johnson & Johnson drug for HIV, the company said Monday.

Tibotec Therapeutics, a subsidiary of J&J, said the FDA approved a 200-mg formulation of Intelence (etravirine) for treating HIV in patients who have taken previous treatments and whose virus has become resistant to antiretroviral drugs.

June 9, 2010

Procter & Gamble voluntarily recalled specific lots of its Iams canned cat food in North...