Content about Amides

April 11, 2014

Mylan on Friday confirmed that a federal district court has granted its request to enforce a settlement agreement between Endo Pharmaceuticals and Mylan settling patent litigation in connection with Mylan's filing of an abbreviated new drug application with the Food and Drug Administration for frovatriptan succinate tablets, 2.5 mg.

PITTSBURGH — Mylan on Friday confirmed that a federal district court has granted its request to enforce a settlement agreement between Endo Pharmaceuticals and Mylan settling patent litigation in connection with Mylan's filing of an abbreviated new drug application with the Food and Drug Administration for frovatriptan succinate tablets, 2.5 mg. This product is the generic version of Frova, which is used to treat acute migraine headaches in adults. 

March 31, 2014

Greenstone announced the introduction of Piroxicam capsules to its generic pharmaceutical product line. The drug is offered in dosage strengths of 10 mg and 20 mg, and is the generic equivalent to Feldene.

PEAPACK, N.J. — Greenstone announced the introduction of Piroxicam capsules to its generic pharmaceutical product line. The drug is offered in dosage strengths of 10 mg and 20 mg, and is the generic equivalent to Feldene.

Piroxicam is intended for the relief of the signs and symptoms of osteoarthritis and rheumatoid arthritis. This new, authorized generic adds to Greenstone’s growing line of products, and is backed by the distribution and customer service support of Pfizer Inc., the company said.

 

February 18, 2014

Sun Pharmaceutical Industries announced that the Food and Drug Administration has granted final approval for its generic version of Temodar temozolomide capsules in 5-mg, 20-mg, 100-mg 140-mg, 180-mg and 250-mg form.

MUMBAI — Sun Pharmaceutical Industries announced that the Food and Drug Administration has granted final approval for its generic version of Temodar temozolomide capsules in 5-mg, 20-mg, 100-mg 140-mg, 180-mg and 250-mg form.

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.

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.

November 26, 2013

The Food and Drug Administration has approved a new tablet form of an antifungal drug made by Merck, the company said Tuesday.

WHITEHOUSE STATION, N.J. — The Food and Drug Administration has approved a new tablet form of an antifungal drug made by Merck, the company said Tuesday.

Merck announced the FDA approval of Noxafil (posaconazole) 100-mg delayed release tablets. The company also markets a 40-mg-per-milliliter oral suspension form of the drug. The new tablet formulation is designed to be taken in two 300-mg doses on the first day, followed by a 300-mg dose once per day.

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.

October 23, 2013

Drug maker Depomed has sold its interests in royalty and milestone payments for several Type 2 diabetes drugs to PDL BioPharma, Depomed said.

NEWARK, Calif. — Drug maker Depomed has sold its interests in royalty and milestone payments for several Type 2 diabetes drugs to PDL BioPharma, Depomed said.

The drug maker announced that it had sold its interest in the Type 2 diabetes therapeutic area to PDL for $240.5 million, which it plans to use to acquire rights to products it said would drive long-term growth and build on its expertise in pain and neurology.

September 10, 2013

Drug maker Depomed has expanded the geographic scope of a license agreement it has with Merck for diabetes drugs, the company said.

NEWARK, Calif. — Drug maker Depomed has expanded the geographic scope of a license agreement it has with Merck for diabetes drugs, the company said.

The licensing agreement, which the two companies entered in July 2009, gives Merck a non-exclusive license and other rights to certain Depomed patents for extended-release metformin, while Depomed will receive "modest" royalties on net product sales of the drug Janumet XR (sitagliptin; metformin hydrochloride) in countries in which the licensed patents cover the product.

August 15, 2013

Boehringer Ingelheim, a research-based, global pharmaceutical company, today announced a multi-year agreement with Brigham and Women's Hospital on a long-term study program to assess comparative effectiveness and safety, as well as prescribing patterns, of oral anticoagulants, including Pradaxa, for the reduction of stroke risk in U.S. patients with non-valvular atrial fibrillation.

RIDGEFIELD, Conn. — Boehringer Ingelheim, a research-based, global pharmaceutical company, today announced a multi-year agreement with Brigham and Women's Hospital on a long-term study program to assess comparative effectiveness and safety, as well as prescribing patterns, of oral anticoagulants, including Pradaxa, for the reduction of stroke risk in U.S. patients with non-valvular atrial fibrillation.

August 12, 2013

Teva Pharmaceutical and Perrigo Co. announced the launch of the generic equivalent to Temodar (temozolomide). Teva will manufacture, market and distribute the product in the United States, and both companies will equally share in the cost and profitability of the product in the country.

JERUSALEM and ALLEGAN, Mich. — Teva Pharmaceutical Industries Ltd., and Perrigo Co. today announced the launch of the generic equivalent to Temodar (temozolomide). Teva will manufacture, market and distribute the product in the United States, and both companies will equally share in the cost and profitability of the product in the country. Teva was first to file, making the product eligible for 180 days of marketing exclusivity.

August 6, 2013

The Food and Drug Administration has approved a generic heart disease drug made by Lupin, the Indian drug maker said.

BALTIMORE — The Food and Drug Administration has approved a generic heart disease drug made by Lupin, the Indian drug maker said.

Lupin said the FDA approved its ranolazine extended-release tablets in the 500-mg and 1,000-mg strengths. The drug is used to treat chronic angina.

Ranolazine extended-release tablets are a generic version of Gilead Sciences' Ranexa, which had sales of about $443.4 million during the 12-month period that ended in March, according to IMS Health.

 

August 5, 2013

A new treatment for bacterial infections of the vagina is now available, the drug's manufacturer said.

ST. LOUIS — A new treatment for bacterial infections of the vagina is now available, the drug's manufacturer said Monday.

K-V Pharmaceutical Co. subsidiary Ther-Rx Corp. announced the availability of Clindesse (clindamycin phosphate), saying wholesalers have ordered and received it and are distributing it to retail pharmacies. The drug is used to treat bacterial vaginosis in women who are not pregnant. BV results from an overgrowth of several bacterial species and is the most common vaginal infection in women of childbearing age.

July 12, 2013

The Food and Drug Administration has approved a new lung cancer drug made by Boehringer Ingelheim, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new lung cancer drug made by Boehringer Ingelheim, the agency said Friday.

The FDA announced the approval of Gilotrif (afatinib) for patients with non-small cell lung cancer that has spread to other parts of the body and whose tumors include certain epidermal growth factor receptor gene mutations. The drug works by blocking proteins that promote the development of cancer cells.

April 19, 2013

The Food and Drug Administration has given tentative approval to two generic diabetes drugs made by Sun Pharmaceutical Industries, the Indian drug maker said.

MUMBAI, India — The Food and Drug Administration has given tentative approval to two generic diabetes drugs made by Sun Pharmaceutical Industries, the Indian drug maker said.

Sun announced the tentative approvals for sitagliptin tablets in the 25 mg, 50 mg and 100 mg strengths and metformin hydrochloride extended-release tablets in the 500 mg and 1,000 mg strengths. The drugs are respectively generic versions of Merck's Januvia and Santarus' Glumetza.

April 4, 2013

Swiss drug maker Covis Pharma will buy U.S. rights to five drugs from Sanofi, Covis said.

ZUG, Switzerland — Swiss drug maker Covis Pharma will buy U.S. rights to five drugs from Sanofi, Covis said Thursday.

February 8, 2013

The Food and Drug Administration has given tentative approval to a generic drug for treating hypertension, according to agency records.

 SILVER SPRING, Md. - The Food and Drug Administration has given tentative approval to a generic drug for treating hypertension, according to agency records.

The FDA granted tentative approval to Dr. Reddy's Labs' valsartan tablets in the 40 mg, 80 mg, 160 mg and 320 mg strengths.

The drug is a generic version of Novartis' Diovan. Various versions of the drug had sales of $1.6 billion during the 12-month period that ended in June, according to IMS Health.

January 17, 2013

Boehringer Ingelheim Pharmaceuticals has enrolled the first patients in its late-stage trial of a treatment for hepatitis C, the drug maker said Thursday.

RIDGEFIELD, Conn. — Boehringer Ingelheim Pharmaceuticals has enrolled the first patients in its late-stage trial of a treatment for hepatitis C, the drug maker said Thursday.

BI Pharmaceuticals is conducting the "HCVerso" trial of an HCV drug that combines faldaprevir, the experimental compound BI 207127 and ribavirin. The company has established trial sites in more than 25 states.

December 28, 2012

Solidifying Perrigo’s leadership position in topical foam-based generic prescription pharmaceuticals, the company announced it has signed a definitive merger agreement and completed the acquisition of Cobrek Pharmaceuticals.

ALLEGAN, Mich. — Solidifying Perrigo’s leadership position in topical foam-based generic prescription pharmaceuticals, the company announced it has signed a definitive merger agreement and completed the acquisition of Cobrek Pharmaceuticals, a privately-held, Chicago-based drug development company, for approximately $45 million.

November 8, 2012

Members of a prescription-drug program offered by Humana to Medicare beneficiaries will soon be able to obtain hypertension drugs from Walmart for a penny.

BENTONVILLE, Ark. — Members of a prescription drug program offered by Humana to Medicare beneficiaries will soon be able to obtain hypertension drugs from Walmart for a penny.

That's right: $0.01.

September 24, 2012

Generic drug maker Sandoz has launched an authorized generic version of a drug used to treat hypertension.

NEW YORK — Generic drug maker Sandoz has launched an authorized generic version of a drug used to treat hypertension.

The generics division of Swiss drug maker Novartis announced the introduction of valsartan and hydrochlorothiazide tablets, a generic version of Novartis' Diovan HCT. Novartis will continue marketing the branded version of the drug, which had sales of $2.3 billion in 2011 together with Diovan (valsartan).

September 21, 2012

The Food and Drug Administration has approved a blood pressure medication made by Mylan.

PITTSBURGH — The Food and Drug Administration has approved a blood pressure medication made by Mylan.

The drug maker announced Friday the approval of valsartan and hydrochlorothiazide tablets in the 80-mg/12.5-mg, 160-mg/12.5-mg, 160-mg/25-mg, 320-mg/12.5-mg and 320-mg/25-mg strengths.

The drug, a generic version of Novartis' Diovan HCT, is used to treat high blood pressure, or hypertension, in patients who can't control their blood pressure with one drug or who are starting therapy and need multiple drugs.

March 7, 2012

A drug under development by Forest Labs and Pierre Fabre "significantly" reduced symptoms of major depressive disorder, the companies said Wednesday.

NEW YORK — A drug under development by Forest Labs and Pierre Fabre "significantly" reduced symptoms of major depressive disorder, the companies said Wednesday.

New York-based Forest and Paris-based Pierre Fabre announced results of a phase-3 trial of levomilnacipran, saying the drug showed reductions in symptoms as early as one week after treatment was started. The companies expect results of another phase-3 trial of the drug this spring.

March 24, 2011

The Food and Drug Administration has approved a topical pain treatment made by Hi-Tech Pharmacal, the drug maker said Thursday.

AMITYVILLE, N.Y. — The Food and Drug Administration has approved a topical pain treatment made by Hi-Tech Pharmacal, the drug maker said Thursday.

The agency approved Hi-Tech’s sterile lidocaine jelly in the 2% strength, used for treating pain in procedures involving the urethra, painful urethritis and in endotracheal intubation.

Various versions of the drug had sales of $17 million in 2010, according to IMS Health.