Content about Generic drug

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 29, 2013

Actavis hopes to become the first to market a generic drug for treating chronic pain, the company said.

PARSIPPANY, N.J. — Actavis hopes to become the first to market a generic drug for treating chronic pain, the company said Monday.

Actavis said it had filed with the Food and Drug Administration for approval of tapentadol extended-release tablets in the 50-mg, 100-mg, 150-mg and 200-mg strengths. The drug is a generic version of Johnson & Johnson subsidiary Janssen Pharmaceuticals' Nucynta ER. The drug is used as a continuous, around-the-clock analgesic over a long period of time.

July 29, 2013

Dr. Reddy's Labs has launched a generic drug used to treat Alzheimer's disease, the company said.

HYDERABAD, India — Dr. Reddy's Labs has launched a generic drug used to treat Alzheimer's disease, the company said.

The Indian drug maker announced the launch of donepezil hydrochloride tablets in the 23-mg strength, a generic version of Eisai and Pfizer's Aricept. The drug is being launched in 30- and 90-count bottles.

Aricept in the 23-mg strength had sales of about $92.6 million during the 12-month period that ended in May, according to IMS Health.

 

July 29, 2013

Drug maker Pfizer is planning to split its commercial division into three business lines that will separate its branded and generic products, the company said Monday.

NEW YORK — Drug maker Pfizer is planning to split its commercial division into three business lines that will separate its branded and generic products, the company said Monday.

July 26, 2013

A federal court has ruled in favor of generic drug maker Sandoz in a case involving a drug for multiple sclerosis, Sandoz said.

PRINCETON, N.J. — A federal court has ruled in favor of generic drug maker Sandoz in a case involving a drug for multiple sclerosis, Sandoz said.

Sandoz, the generics division of Switerland-based Novartis, said the U.S. Federal Circuit Court of Appeals invalidated nine patents owned by Israel-based Teva Pharmaceutical Industries covering the drug Copaxone (glatiramer acetate).

July 25, 2013

Mylan and Orion Corp. have settled a patent-infringement suit over a drug used to treat Parkinson's disease.

PITTSBURGH — Mylan and Orion Corp. have settled a patent-infringement suit over a drug used to treat Parkinson's disease, Mylan said Thursday.

The generic drug maker had filed with the Food and Drug Administration for a generic version of Orion's Stalevo (carpidopa; levodopa; entacapone) tablets, used to treat idiopathic Parkinson's to substitute for immediate-release carbidopa/levodopa and entacapone administered separately.

July 24, 2013

Mylan has settled with the makers of a drug used to treat cancer in a patent-infringement lawsuit, the generic drug maker said.

PITTSBURGH — Mylan has settled with the makers of a drug used to treat cancer in a patent-infringement lawsuit, the generic drug maker said Wednesday.

Mylan said it had entered an agreement with Pfizer, Genentech and OSI that would allow their suit against Mylan over the drug Tarceva (erlotinib) to be dismissed. All other terms and conditions of the settlement are confidential, and the agreement is subject to Department of Justice and Federal Trade Commission review, Mylan said.

July 22, 2013

A new bill would exempt user fees paid by drug companies to the Food and Drug Administration — including those of generic drug makers — from the automatic federal budget cuts that went into effect in March, commonly known as the sequester.

WASHINGTON — A new bill would exempt user fees paid by drug companies to the Food and Drug Administration — including those of generic drug makers — from the automatic federal budget cuts that went into effect in March, commonly known as the sequester.

The bill, the FDA Safety Over Sequestration Act, received sponsorship from Reps. Leonard Lance, R-N.J.; Anna Eshoo, D-Calif.; Doris Matsui, D-Calif.; and Mike Rogers, R-Mich. Generic drug industry trade group the Generic Pharmaceutical Association heralded the bill.

July 22, 2013

Decisions on whether to bring new generic drugs to market depend significantly on companies' ability to settle patent lawsuits filed by branded drug companies, according to a new white paper.

WASHINGTON — Decisions on whether to bring new generic drugs to market depend significantly on companies' ability to settle patent lawsuits filed by branded drug companies, according to a new white paper.

July 18, 2013

Taro Pharmaceutical Industries has appointed Dilip Shanghvi as chairman, the Israeli generic drug maker said Thursday.

HAWTHORNE, N.Y. — Taro Pharmaceutical Industries has appointed Dilip Shanghvi as chairman, the Israeli generic drug maker said Thursday.

Taro said James Kedrowski would retire as interim CEO effective Aug. 1, to be replaced by Kalyanasundaram "Kal" Subramanian. Kedrowski will continue to serve as a member of the drug maker's board. Sundaram relinquished his position as chairman to comply with Israeli laws that prohibit a person from simultaneously holding the positions of chairman and CEO; he had served as chairman since April 2012.

July 16, 2013

The Food and Drug Administration has approved a generic epilepsy and bipolar disorder drug made by Actavis, the drug maker said.

PARSIPPANY, N.J. — The Food and Drug Administration has approved a generic epilepsy and bipolar disorder drug made by Actavis, the drug maker said.

The generic drug maker announced that it had received FDA approval for lamotrigine orally disintegrating tablets in the 25-mg, 50-mg, 100-mg and 200-mg strengths, a generic version of GlaxoSmithKline's Lamictal ODT.

July 15, 2013

Mylan has launched a generic drug for treating cholesterol problems, the company said Monday.

PITTSBURGH — Mylan has launched a generic drug for treating cholesterol problems, the company said Monday.

Mylan announced the launch of generic fenofibric acid delayed-release capsules in the 45-mg and 135-mg strengths.

The drug is a generic version of Abbott's Trilipix, designed for use in combination with statin drugs and diet to reduce triglycerides and increase high-density lipoprotein or "good" cholesterol.

Various versions of the drug had sales of about $553.6 million during the 12-month period that ended in March, according to IMS Health.

July 12, 2013

Actavis is looking to become the first to market a generic drug for epilepsy, the company said.

PARSIPPANY, N.J. — Actavis is looking to become the first to market a generic drug for epilepsy, the company said Friday.

Actavis announced that it had filed with the Food and Drug Administration for lacosamide tablets in the 50-mg, 100-mg, 150-mg and 200-mg strengths. The drug is a generic version of UBC's Vimpat and is used to treat partial-onset seizures in epilepsy patients aged 17 and older.

July 12, 2013

The Indian generic drug maker announced the approval of repaglinide tablets in the 1-mg and 2-mg strengths, which are used in combination with diet and exercise to improve blood-sugar control in patients with Type 2 diabetes.

MUMBAI, India — The Food and Drug Administration has approved a generic diabetes drug made by Sun Pharmaceutical Industries, Sun said Friday.

The Indian generic drug maker announced the approval of repaglinide tablets in the 1-mg and 2-mg strengths, which are used in combination with diet and exercise to improve blood-sugar control in patients with Type 2 diabetes.

July 11, 2013

Mylan is challenging a patent on a drug used to treat ulcerative proctitis, the generic drug maker said Thursday.

PITTSBURGH — Mylan is challenging a patent on a drug used to treat ulcerative proctitis, the generic drug maker said Thursday.

Mylan said it had filed a regulatory approval application with the Food and Drug Administration for melamine rectal suppositories in the 1,000-mg strength. The drug is a generic version of Canasa, which had sales of about $153 million during the 12-month period that ended in March, according to IMS Health.

July 9, 2013

The Food and Drug Administration has approved a generic drug for treating Alzheimer's disease, FDA records showed.

SILVER SPRING, Md. — The Food and Drug Administration has approved a generic drug for treating Alzheimer's disease, FDA records showed.

The agency announced the approval of Alvogen's donepezil hydrochloride, a generic version of Aricept, made by Pfizer and Eisai. The generic drug was approved in the 5 mg and 10 mg strengths.

More than 20 other companies also make generic versions of Aricept. The drug is used to treat mild to moderate Alzheimer's, as well as severe forms of the disease.

 

July 9, 2013

The Food and Drug Administration has made a significant dent in its large backlog of generic drug applications thanks to amendments to last year's reauthorization of the Prescription Drug User Fee Act, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has made a significant dent in its large backlog of generic drug applications thanks to amendments to last year's reauthorization of the Prescription Drug User Fee Act, the agency said Tuesday.

July 9, 2013

The U.S. healthcare system has saved $25.5 billion over seven years from generic drugs launched under patent settlements between branded and generic drug manufacturers, according to a new study.

WASHINGTON — The U.S. healthcare system has saved $25.5 billion over seven years from generic drugs launched under patent settlements between branded and generic drug manufacturers, according to a new study.

July 1, 2013

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

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

The Indian generic drug maker announced the launch of lamotrigine extended-release tablets in the 25-mg, 50-mg, 100-mg, 200-mg and 300-mg strengths. The drug is being distributed in bottle sizes of 30.

Lamotrigine extended-release tablets are a generic version of GlaxoSmithKline's Lamictal XR, branded and generic versions of which had sales of $300.5 million during the 12-month period that ended in April, according to IMS Health.

 

June 25, 2013

The Food and Drug Administration has given special designation to a drug made by Raptor Pharmaceuticals for a rare metabolic disease.

NOVATO, Calif. — The Food and Drug Administration has given special designation to a drug made by Raptor Pharmaceuticals for a rare metabolic disease.

June 25, 2013

The head of generic drug maker Impax Labs will retire, the company said Tuesday.

HAYWARD, Calif. — The head of generic drug maker Impax Labs will retire, the company said Tuesday.

Impax said president and CEO Larry Hsu would retire, but would remain with the company until a replacement CEO is found and he would remain as a board member following the appointment of his successor. Hsu cofounded the company in 1994.

A three-person search committee to find a new CEO will include Hsu, Allen Chao and board chairman Bob Burr.

 

June 24, 2013

A White House trade policy leader has been appointed as U.S. Trade Representative.

WASHINGTON — A White House trade policy leader has been appointed as U.S. trade representative.

The Senate voted last week to approve Michael Froman to the position. Froman was previously an adviser to President Barack Obama on international economic affairs and replaces acting U.S. Trade Representative Miriam Sapiro.

June 24, 2013

Generic drug makers cannot be held liable if patients suffer harmful side effects after taking their drugs, the Supreme Court has ruled in a 5-4 decision.

WASHINGTON — Generic drug makers cannot be held liable if patients suffer harmful side effects after taking their drugs, the Supreme Court has ruled in a 5-4 decision.

June 24, 2013

Rite Aid reported its third consecutive profitable quarter Thursday, with profits of nearly $90 million, following the introduction of the largest expansion of its Wellness+ loyalty card program, dubbed Wellness65+, and days before the promotion of COO Ken Martindale to president of the company.

The 4,615-store drug chain has been on a roll lately, continuing to benefit from the switch from branded to generic drugs and the retention of last year's dispute between Walgreens and Express Scripts.

Rite Aid reported its third consecutive profitable quarter Thursday, with profits of nearly $90 million, following the introduction of the largest expansion of its Wellness+ loyalty card program, dubbed Wellness65+, and days before the promotion of COO Ken Martindale to president of the company.

June 20, 2013

Tris Pharma has hired a former buyer from AmerisourceBergen to head its generic drug business, the company said.

MONMOUTH JUNCTION, N.J. — Tris Pharma has hired a former buyer from AmerisourceBergen to head its generic drug business, the company said.

Tris announced the appointment of Janet Penner as president of the new generic pharmaceuticals business, which will have its own sales, marketing and distribution and will be responsible for bringing drugs to market. So far, the Food and Drug Administration has approved 13 of Tris' generics, including several first-to-market products.