Content about Shionogi

December 2, 2013

Shionogi and Egalet have entered a deal worth up to $425 million for the development of abuse-deterrent opioid painkillers, Egalet said.

MALVERN, Pa. — Shionogi and Egalet have entered a deal worth up to $425 million for the development of abuse-deterrent opioid painkillers, Egalet said.

The deal centers on the development and potential commercialization of experimental drugs containing the opioid painkiller hydrocodone.

March 14, 2013

Mylan has settled a patent-infringement lawsuit filed by Shionogi over its generic version of a drug for diabetes, Mylan said.

PITTSBURGH — Mylan has settled a patent-infringement lawsuit filed by Shionogi over its generic version of a drug for diabetes, Mylan said.

The generic drug maker said that under the agreement, it can launch a generic version of Shionogi's Fortamet (metformin hydrochloride) extended-release tablets in the 500-mg and 1,000-mg strengths on Aug. 1.

Metformin hydrochloride extended-release tablets in those two strengths had sales of about $125 million during the 12-month period that ended in September, according to IMS Health.

 

February 26, 2013

The Food and Drug Administration has approved a drug for postmenopausal women who experience pain during sex.

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug for postmenopausal women who experience pain during sex.

The agency announced the approval of Shionogi's Osphena (ospemifene) for women with moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy due to menopause associated with declining levels of estrogen hormones.

October 10, 2012

Mylan has settled a patent infringement suit over a drug used to treat respiratory diseases, Mylan said.

PITTSBURGH — Mylan has settled a patent infringement suit over a drug used to treat respiratory diseases, Mylan said.

The generic drug maker said it resolved a patent litigation suit filed by Shionogi and Cima Labs over prednisolone sodium phosphate orally disintegrating tablets, a generic version of Orapred ODT. Mylan is hoping to market its generic version of the drug in the 10-mg, 15-mg and 30-mg strengths. The drug is used to treat asthma and certain allergic conditions.

August 28, 2012

Merz announced it has acquired a medication designed to treat a condition associated with such neurologic conditions as cerebral palsy.

GREENSBORO, N.C. — Merz announced it has acquired a medication designed to treat a condition associated with such neurologic conditions as cerebral palsy.

June 29, 2012

The Food and Drug Administration has accepted a regulatory approval application for a drug made by Shionogi for treating vulvar and vaginal atrophy due to menopause.

FLORHAM PARK, N.J. — The Food and Drug Administration has accepted a regulatory approval application for a drug made by Shionogi for treating vulvar and vaginal atrophy due to menopause.

Shionogi, the U.S. division of Japanese drug maker Shionogi & Co., said Wednesday that the FDA had accepted for review its application for ospemifene, which the company touts as potentially the first oral alternative to vaginal estrogen treatments.

April 23, 2012

Watson Pharmaceuticals announced the launch of an authorized generic version of a drug used to lower blood glucose in patients with Type 2 diabetes.

PARSIPPANY, N.J. — Watson Pharmaceuticals announced the launch of an authorized generic version of a drug used to lower blood glucose in patients with Type 2 diabetes.

April 10, 2012

Prasco Labs has launched an authorized generic version of a blood-pressure drug made by Shionogi, the company said.

CINCINNATI — Prasco Labs has launched an authorized generic version of a blood-pressure drug made by Shionogi, the company said.

Prasco announced the launched of nisoldipine extended-release tablets in the 8.5-mg, 17-mg and 34-mg strengths.

The drug is an authorized generic version of Shionogi's Sular. Authorized generics are branded drugs marketed under their generic names at reduced prices, usually under a partnership between the branded drug's manufacturer and an outside company.

September 12, 2011

The Generic Pharmaceutical Association has named Ralph Neas as its new president and CEO.

EXECUTIVE NEWS — The Generic Pharmaceutical Association has named Ralph Neas as its new president and CEO. Neas, currently president and CEO of the National Coalition on Health Care, replaces Kathleen Jaeger, who stepped down as president and CEO of GPhA in May 2010 after eight years with the organization. The GPhA said it planned to spend September introducing Neas to stakeholders in a broad outreach effort.


August 22, 2011

Prasco will market an authorized generic drug for urinary tract infections under an agreement with Shionogi, the company said Monday.

CINCINNATI — Prasco will market an authorized generic drug for urinary tract infections under an agreement with Shionogi, the company said Monday.

Prasco announced that it signed a supply agreement with Shinogi to market and distribute nitrofurantoin oral suspension, an authorized generic version of Furadantin. Authorized generics are branded drugs marketed under their generic names at a discounted price, usually through a third-party company, such as Prasco.

July 25, 2011

Prasco Labs has contracted to sell an authorized generic version of a painkiller made by Shionogi, Prasco said Monday.

CINCINNATI — Prasco Labs has contracted to sell an authorized generic version of a painkiller made by Shionogi, Prasco said Monday.

Under the agreement between the two companies, Prasco will market and distribute an authorized generic version of Ponstel (mefenamic acid) capsules in the 250-mg strength.

May 23, 2011

A generic drug maker has been granted approval from the Food and Drug Administration to manufacture its version of a urinary tract infection treatment.

BRIDGEWATER, N.J. — A generic drug maker has been granted approval from the Food and Drug Administration to manufacture its version of a urinary tract infection treatment.

Amneal Pharmaceuticals said that its nitrofurantoin oral suspension in the 25-mg/5-mL strength is the first-to-market, AB-rated, generic version of Furadantin, which is made by Shionogi Pharma.

Amneal will sell its generic in 8-oz./230-mL size bottles, the company said.

April 7, 2011

A treatment made by Shionogi for chronic, severe drooling in children and teenagers with neurological conditions has become available, the drug maker said Thursday.

FLORHAM PARK, N.J. — A treatment made by Shionogi for chronic, severe drooling in children and teenagers with neurological conditions has become available, the drug maker said Thursday.

January 10, 2011

Drug maker Shionogi has launched a new medication for attention deficit hyperactivity disorder, the company said Monday.

FLORHAM PARK, N.J. — Drug maker Shionogi has launched a new medication for attention deficit hyperactivity disorder, the company said Monday.

Shionogi announced the launch of Kapvay (clonidine hydrochloride), an extended-release drug for treating ADHD in children and adolescents. The company said the drug was the only ADHD treatment approved as an add-on to stimulant medications, though it can be used alone as well.

October 3, 2010

The Food and Drug Administration has approved a nonstimulant drug for treating attention deficit hyperactivity...

FLORHAM PARK, N.J. The Food and Drug Administration has approved a nonstimulant drug for treating attention deficit hyperactivity disorder.

 

Shionogi announced Monday the approval of Kapvay (clonidine hydrochloride), an extended-release drug for treating ADHD in children and adolescents ages 6 to 17 years. The company said Kapvay was the only formulation of clonidine hydrochloride approved for treating ADHD and the first ADHD treatment approved for use as an add-on therapy to stimulant drugs.