Content about Erectile dysfunction

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.

October 11, 2013

Auxilium Pharmaceuticals will have exclusive rights to market a drug for erectile dysfunction in the United States and Canada, under a new licensing agreement with the drug's manufacturer.

CHESTERBROOK, Pa. — Auxilium Pharmaceuticals will have exclusive rights to market a drug for erectile dysfunction in the United States and Canada, under a new licensing agreement with the drug's manufacturer.

July 16, 2013

Men who took an erectile dysfunction drug made by Eli Lilly experienced normal erectile function when taking it once a day as opposed to taking erectile dysfunction treatment on an as-needed basis, according to a new study.

INDIANAPOLIS — Men who took an erectile dysfunction drug made by Eli Lilly experienced normal erectile function when taking it once a day as opposed to taking erectile dysfunction treatment on an as-needed basis, according to a new study.

The study, published in the Journal of Sexual Medicine, found a greater percentage of men who had an incomplete response to as-needed treatment with phosphodiesterase type 5, or PDE5 inhibitors, a drug class that includes Lilly's Cialis (tadalafil), compared with those who took Cialis once a day.

June 26, 2013

Teva Pharmaceutical Industries and Mylan have launched generic versions of Pfizer's Viagra in nearly a dozen European countries, the two companies said.

NEW YORK — Teva Pharmaceutical Industries and Mylan have launched generic versions of Pfizer's Viagra in nearly a dozen European countries, the two companies said.

Teva, based in Jerusalem, announced the launch of generic sildenafil tablets in Germany, the United Kingdom, Italy, the Netherlands, Switzerland, Ireland, Austria, Belgium and Denmark. The company already markets generic versions of the erectile dysfunction drug in Spain and Canada.

March 21, 2013

The Food and Drug Administration advised consumers not to purchase or use three separate sexual enhancement products that are being promoted as dietary supplements because they contain undeclared and unapproved prescription-only ingredients.

BETHESDA, Md. — The Food and Drug Administration on Thursday advised consumers not to purchase or use three separate sexual enhancement products that are being promoted as dietary supplements because they contain undeclared and unapproved prescription-only ingredients. 

February 8, 2013

A new report by Francesco International identified $35.7 billion worth of potential Rx-to-OTC switches in a wide range of indications, from hypertension and chronic obstructive pulmonary disorder to high cholesterol and erectile dysfunction, and the Food and Drug Administration has been looking at ways technology and pharmacists could be employed to ensure that patients taking drugs new to the consumer health space take them appropriately.

With growth in traditional pharmaceuticals expected to slow down significantly, a growing number of drug makers — branded and generic alike — see specialty drugs as their main sources of revenue for the foreseeable future. At the same time, those drug makers not invested in specialty may be looking for growth opportunities in consumer health.

A new report by Francesco International identified $35.7 billion worth of potential Rx-to-OTC switches in a wide range of indications, from hypertension and chronic obstructive pulmonary disorder to high cholesterol and erectile dysfunction, and the Food and Drug Administration has been looking at ways technology and pharmacists could be employed to ensure that patients taking drugs new to the consumer health space take them appropriately

May 16, 2012

The Food and Drug Administration on Wednesday identified three online products touting "natural" intimacy enhancement that consumers should avoid because they each contain undeclared pharmaceutical ingredients.

SILVER SPRING, Md. — The Food and Drug Administration on Wednesday identified three online products touting "natural" intimacy enhancement that consumers should avoid because they each contain undeclared pharmaceutical ingredients.

The three products include Boost ultra sexual enhancement formula, VMaxx Rx and Firminite.

May 16, 2012

Watson has announced its intention to acquire Actavis, the company said. Following news reports that the U.S.-based generic drug maker would acquire Switzerland-based Actavis, Watson announced that it would buy the latter for $5.6 billion.

SUPPLIER NEWS — Watson has announced its intention to acquire Actavis, the company said. Following news reports that the U.S.-based generic drug maker would acquire Switzerland-based Actavis, Watson announced that it would buy the latter for $5.6 billion. News media had reported that the deal would be worth $5.9 billion, while there had been estimates in March that Watson would pay up to $7.3 billion. 


April 27, 2012

The Food and Drug Administration has approved a new drug for treating erectile dysfunction, the agency said Friday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for treating erectile dysfunction, the agency said Friday.

The FDA announced the approval of Vivus' Stendra (avanafil).

"This approval expands the available treatment options to men experiencing erectile dysfunction and enables patients, in consultation with their doctor, to choose the most appropriate treatment for their needs," FDA Office of Drug Evaluation III deputy director Victoria Kusiak said.

October 12, 2011

A drug made by Eli Lilly & Co. produced "significant" improvements in patients with erectile dysfunction who also had benign prostatic hyperplasia, according to results of a new study.

INDIANAPOLIS — A drug made by Eli Lilly & Co. produced "significant" improvements in patients with erectile dysfunction who also had benign prostatic hyperplasia, according to results of a new study.

The phase-3 study, published in the Journal of Sexual Medicine, found that Cialis (tadalafil) improved erectile dysfunction and benign prostatic hyperplasia in men with both conditions. BPH is a condition in which the prostate enlarges, causing urinary symptoms.

October 7, 2011

The Food and Drug Administration has approved a new use for a drug made by Eli Lilly for erectile dysfunction, Lilly said Friday.

INDIANAPOLIS — The Food and Drug Administration has approved a new use for a drug made by Eli Lilly for erectile dysfunction, Lilly said Friday.

The FDA approved Cialis (tadalafil) as a once-daily treatment for men with erectile dysfunction and benign prostatic hyperplasia, also known as BPH, as well as for BPH alone. BPH is a condition in which the prostate enlarges, which can cause urinary symptoms.

September 7, 2011

The Food and Drug Administration has accepted a regulatory approval application for a drug made by Vivus for treating erectile dysfunction.

MOUNTAIN VIEW, Calif. — The Food and Drug Administration has accepted a regulatory approval application for a drug made by Vivus for treating erectile dysfunction.

Vivus said it expected the Food and Drug Administration to complete its review of the application for avanafil by April 29, 2012.

"We are pleased with FDA's acceptance of our NDA," Vivus president Peter Tam said. "If approved, avanafil could be a valuable treatment alternative for the 18 million men in the United States that suffer from ED."

June 3, 2011

Generic drug maker Watson Labs is hoping to market a generic version of a Pfizer drug for erectile dysfunction.

PARSIPPANY, N.J. — Generic drug maker Watson Labs is hoping to market a generic version of a Pfizer drug for erectile dysfunction.

Watson announced Thursday that it had filed a regulatory approval application with the Food and Drug Administration to market a generic version of Viagra (sildenafil citrate) tablets in 25-mg, 50-mg and 100-mg strengths.

May 16, 2011

The Food and Drug Administration on Friday warned consumers about a counterfeit product represented as "ExtenZe," which is the name of an authentic dietary supplement for male sexual enhancement.

SILVER SPRING, Md. — The Food and Drug Administration on Friday warned consumers about a counterfeit product represented as "ExtenZe," which is the name of an authentic dietary supplement for male sexual enhancement.

The counterfeit product looks similar to the actual product, but either contains tadalafil, or a combination of tadalafil and sildenafil, all active ingredients in FDA-approved prescription medicines for erectile dysfunction.

April 14, 2011

Drug manufacturers are coming up with new versions of their drugs for erectile dysfunction as those drugs’ loss of patent protection and subsequent generic competition draw near, according to published reports.

NEW YORK — Drug manufacturers are coming up with new versions of their drugs for erectile dysfunction as those drugs’ loss of patent protection and subsequent generic competition draw near, according to published reports.

March 3, 2011

Long-term use of a class of drugs used to control pain could increase the risk of erectile dysfunction in men, according to a new study.

PASADENA, Calif. — Long-term use of a class of drugs used to control pain could increase the risk of erectile dysfunction in men, according to a new study.

The study, sponsored by Kaiser Permanente and published online in the Journal of Urology, found that men who took nonsteroidal anti-inflammatory drugs, or NSAIDs, three times a day for more than three months were 2.4 times as likely to have erectile dysfunction as men who didn’t take the drugs regularly. The study used data from 80,966 men ages 45 to 69 years in California.

February 23, 2011

Biotab Nutraceuticals on Tuesday initiated a voluntary recall of two lots of Extenze nutritional supplement tablets.

MONROVIA, Calif. — Biotab Nutraceuticals on Tuesday initiated a voluntary recall of two lots of Extenze nutritional supplement tablets.

Some packages bearing lot numbers 0709241 and 0509075 are counterfeit products containing undeclared drug ingredients that can pose a serious risk to health, the company stated.

February 15, 2011

It shouldn’t surprise people too much, but pills to treat male impotence tend to see big increases in prescriptions around Valentine’s Day, according to published reports.

NEW YORK — It shouldn’t surprise people too much, but pills to treat male impotence tend to see big increases in prescriptions around Valentine’s Day, according to published reports.

Bloomberg reported that prescriptions of such drugs as Pfizer’s Viagra (sildenafil) and Eli Lilly’s Cialis (tadalafil) are at their highest in the days leading up to the holiday.

November 10, 2010

A specialty pharmacy provider and a manufacturer will collaborate to provide treatments for erectile dysfunction....

LAKE MARY, Fla. A specialty pharmacy provider and a manufacturer will collaborate to provide treatments for erectile dysfunction.

 

Axium Healthcare Pharmacy and Firma Medical announced the partnership Wednesday where by Axium’s erectile dysfunction line of injectable compounded pharmaceuticals will be marketed to Firma’s physician and patient customers around the country. The companies said the deal would give Axium broader distribution while increasing the number of treatment options for Firma’s customers.

 

September 28, 2010

The Federal Trade Commission has sued the maker of a pomegranate juice that touts health...

WASHINGTON The Federal Trade Commission has sued the maker of a pomegranate juice that touts health benefit claims.

 

August 12, 2010

Prolatis earlier this week announced a voluntary nationwide recall of the company’s product sold under...

SALT LAKE CITY Prolatis earlier this week announced a voluntary nationwide recall of the company’s product sold under the brand name Prolatis’ after being informed by the Food and Drug Administration that lab analysis has found their male-enhancement products to contain sulfoaildenafil, an analogue of sildenafil, an FDA-approved drug used as treatment for male erectile dysfunction.

 

That makes Prolatis’ an unapproved drug, as opposed to a dietary supplement.