Content about PDE5 inhibitors

March 18, 2014

Pfizer has sued Torrent Pharmaceuticals in an effort to protect its erectile-dysfunction drug Viagra (sildenafil citrate) from generic competition, according to a Bloomberg News report published Tuesday.

NEW YORK — Pfizer has sued Torrent Pharmaceuticals in an effort to protect its erectile-dysfunction drug Viagra (sildenafil citrate) from generic competition, according to a Bloomberg News report published Tuesday

Torrent has filed an aNDA with the Food and Drug Administration, challenging Pfizer's patent that expires on Oct. 22, 2019. 

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.

August 5, 2013

Amneal Pharmaceuticals has introduced five new generic drugs, the company said.

BRIDGEWATER, N.J. — Amneal Pharmaceuticals has introduced five new generic drugs, the company said.

The drugs launched are:

Potassium chloride extended-release capsules in the 750-mg strength and in bottle count sizes of 100, 500 and 1,000. The drug is a generic version of Nesher Pharmaceuticals' Micro-K10 ExtenCaps and used to treat potassium deficiency.

Sildenafil tablets in the 20-mg strength and in 90-count bottles. The drug is a generic version of Pfizer's Revatio, used to treat pulmonary arterial hypertension.

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 14, 2013

The Food and Drug Administration has accepted the resubmission of a regulatory approval application from United Therapeutics for a drug to treat pulmonary arterial hypertension, the drug maker said.

SILVER SPRING, Md. — The Food and Drug Administration has accepted the resubmission of a regulatory approval application from United Therapeutics for a drug to treat pulmonary arterial hypertension, the drug maker said Thursday.

The FDA originally declined to approve the drug, treprostinil diolamine extended-release tablets, in a letter submitted to the company in October 2012.

The agency plans to decide whether or not to approve the drug in March of this year, United Therapeutics said.

November 19, 2012

Dr. Reddy's Labs has launched a generic drug for treating pulmonary arterial hypertension, the company said.

HYDERABAD, India — Dr. Reddy's Labs has launched a generic drug for treating pulmonary arterial hypertension, the company said.

Dr. Reddy's announced the launch of sildenafil tablets in the 20 mg strength in 90-count bottles. The drug is a generic version of Pfizer's Revatio.

Revatio had sales of $338.67 million during the 12-month period ended in September, according to IMS Health.

November 13, 2012

The Food and Drug Administration has approved a generic drug made by Mylan for treating pulmonary arterial hypertension, the drug maker said Tuesday.

PITTSBURGH — The Food and Drug Administration has approved a generic drug made by Mylan for treating pulmonary arterial hypertension, the drug maker said Tuesday.

Mylan announced the FDA approval of sildenafil citrate tablets in the 20-mg strength, a generic version of Pfizer's Revatio. The drug is used to treat adults with PAH to improve exercise ability and delay clinical worsening of the condition.

Revatio had sales of about $339 million during the 12-month period ended in September, according to IMS Health.

November 12, 2012

The Food and Drug Administration has approved a generic drug for pulmonary arterial hypertension made by Watson Pharmaceuticals, the drug maker said Monday.

PARSIPPANY, N.J. — The Food and Drug Administration has approved a generic drug for pulmonary arterial hypertension made by Watson Pharmaceuticals, the drug maker said Monday.

Watson said the FDA approved its sildenafil tablets in the 20 mg strength through a subsidiary. Watson said it would launch the drug "in the near future."

The drug is a generic version of Pfizer's Revatio tablets, which had sales of about $339 million during the 12-month period ended in September, according to IMS Health.

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.

December 23, 2011

According to research to be published in the journal Circulation released Friday, sildenafil, the active ingredient in Viagra, can help alleviate heart problems.

QUERENBURG, Germany — According to research to be published in the journal Circulation released Friday, sildenafil, the active ingredient in Viagra, can help alleviate heart problems.

The research was conducted in collaboration with the Mayo Clinic in Rochester, Minn.

September 29, 2011

Last year, U.S. Customs and Border Protection seized $5.6 million worth of illegal pharmaceutical products, a 170% increase over 2005. Meanwhile, global sales of counterfeit medicines were estimated to be more than $75 billion last year, 90% more than in 2005. In response, Pfizer and the National Association of Boards of Pharmacy announced Thursday the launch of an effort to educate patients on how to safely buy medicines online and about the risks of counterfeit drugs.

NEW YORK — Last year, U.S. Customs and Border Protection seized $5.6 million worth of illegal pharmaceutical products, a 170% increase over 2005. Meanwhile, global sales of counterfeit medicines were estimated to be more than $75 billion last year, 90% more than in 2005.

In response, Pfizer and the National Association of Boards of Pharmacy announced Thursday the launch of an effort to educate patients on how to safely buy medicines online and about the risks of counterfeit drugs.

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."

August 15, 2011

Pfizer announced that the patent for its popular erectile dysfunction treatment was upheld in court.

NEW YORK — Pfizer announced that the patent for its popular erectile dysfunction treatment was upheld in court.

The drug maker said that the U.S. District Court for the Eastern District of Virginia concluded that Pfizer's patent for Viagra was valid and enforceable and prevents generic drug maker Teva from marketing its version of the drug until October 2019. Pfizer noted that litigation on the same patent remains pending against other generic companies, but no trials are scheduled in those other cases.

The court's decision, however, is subject to appeal by Teva.

August 9, 2011

Hetero is at the center of two patent litigation suits for attempting to market generic versions of Viagra and Nexium, according to published reports.

NEW YORK — Hetero is at the center of two patent litigation suits for attempting to market generic versions of Viagra and Nexium, according to published reports.

June 7, 2011

Global Wellness on Tuesday initiated a voluntary nationwide recall of its Via Extreme ultimate sexual enhancer dietary supplement for men.

HOLLYWOOD, Fla. — Global Wellness on Tuesday initiated a voluntary nationwide recall of its Via Extreme ultimate sexual enhancer dietary supplement for men.

The product — a bottle containing six blue-colored capsules per package — was distributed throughout the United States, Puerto Rico and Canada to Internet and retail consumers, the company reported.

Global Wellness is recalling only lots 809013 and 806030; the recall does not affect sales and distribution of Slim Extreme Gold and Gelslim, the company stated.

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.

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.

December 13, 2010

The Food and Drug Administration on Friday warned consumers not to use Man Up Now capsules, which are marketed as a dietary supplement for sexual enhancement, because they contain a variation of an active drug ingredient found in Viagra that can dangerously lower blood pressure.

SILVER SPRING, Md. — The Food and Drug Administration on Friday warned consumers not to use Man Up Now capsules, which are marketed as a dietary supplement for sexual enhancement, because they contain a variation of an active drug ingredient found in Viagra that can dangerously lower blood pressure.