Content about Generic drug

August 30, 2011

Mylan will be banned temporarily from launching a generic drug for acne pending a federal court's decision whether or not to bar it, according to published reports.

NEW YORK — Mylan will be banned temporarily from launching a generic drug for acne pending a federal court's decision whether or not to bar it, according to published reports.

August 29, 2011

A drug made by Pfizer and Bristol-Myers Squibb undergoing late-stage clinical trials was more effective than the generic drug warfarin in patients with atrial fibrillation, according to study results released Sunday.

NEW YORK — A drug made by Pfizer and Bristol-Myers Squibb undergoing late-stage clinical trials was more effective than the generic drug warfarin in patients with atrial fibrillation, according to study results released Sunday.

The phase-3 "ARISTOTLE" trial of Eliquis (apixaban) showed that the drug reduced the risk of stroke and systemic embolism by 21%, major bleeding by 31% and death by 11% in AF patients. The study, published in the New England Journal of Medicine, was conducted at 1,034 centers in 39 countries and enrolled 18,201 patients.

August 24, 2011

Par Pharmaceutical Cos. will acquire Anchen Pharmaceuticals for $410 million, Par said Wednesday.

WOODCLIFF LAKE, N.J. — Par Pharmaceutical Cos. will acquire Anchen Pharmaceuticals for $410 million, Par said Wednesday.

Based in Irvine, Calif., Anchen is a privately owned generic drug maker that expects to launch eight to 10 new generic drugs over the next two years. Par plans to finance the acquisition with a $350 million term loan and cash it already has.

August 23, 2011

The Food and Drug Administration has approved a chemotherapy drug made by Sandoz, the drug maker said Tuesday.

PRINCETON, N.J. — The Food and Drug Administration has approved a chemotherapy drug made by Sandoz, the drug maker said Tuesday.

Sandoz, the generics division of Swiss drug maker Novartis, announced the approval and launch of docetaxel, an injectable chemotherapy drug that the company said was the 11th cancer drug it has launched in the United States.

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.

August 19, 2011

While Indian generic drug maker Ranbaxy Labs is expected by many to launch a generic version of a cholesterol drug made by Pfizer later this year, it may have to sell its rights to it if it can't win Food and Drug Administration approval in time, according to published reports.

NEW YORK — While Indian generic drug maker Ranbaxy Labs is expected by many to launch a generic version of a cholesterol drug made by Pfizer later this year, it may have to sell its rights to it if it can't win Food and Drug Administration approval in time, according to published reports.

Citing Credit Suisse analysts, Bloomberg reported that the FDA may delay approval of Ranbaxy's version of Lipitor (atorvastatin), which would prevent it from marketing the drug starting Nov. 30, as it has planned to do.

August 19, 2011

Generic drug maker Sagent Pharmaceuticals has launched a new drug for neuromuscular disorders, the company said.

SCHAUMBURG, Ill. — Generic drug maker Sagent Pharmaceuticals has launched a new drug for neuromuscular disorders, the company said.

Sagent announced the launch of vecuronium bromide, an injectable drug used to treat myasthenia gravis and Eaton-Lambert syndrome. The disorders cause muscle weakness and fatigue.

The market for vecuronium bromide is about $10 million in the United States, according to IMS Health.

August 19, 2011

Generic drug maker Sandoz is suing Danish drug maker Novo Nordisk over a generic version of a drug used to treat diabetes, according to published reports.

NEW YORK — Generic drug maker Sandoz is suing Danish drug maker Novo Nordisk over a generic version of a drug used to treat diabetes, according to published reports.

Bloomberg reported that Sandoz, the generics arm of Swiss drug maker Novartis, was suing Novo Nordisk in a Detroit federal court, hoping the court would find that the Sandoz generic version of Novo Nordisk's Prandin (repaglinide) did not infringe on the latter company's patent covering the drug.

August 18, 2011

Generic drug maker Sun Pharmaceutical Industries has received regulatory approval for a drug designed to treat an enlarged prostate.

MUMBAI, India — Generic drug maker Sun Pharmaceutical Industries has received regulatory approval for a drug designed to treat an enlarged prostate.

According to the Food and Drug Administration's website, Sun Pharma's finasteride tablets in the 5-mg strength were approved on Aug. 16.

Finasteride is the generic equivalent of Proscar and Propecia, which are made by Merck.

August 12, 2011

Generic drug maker Mylan has begun shipping a drug for enlarged prostate, the company said Friday.

PITTSBURGH — Generic drug maker Mylan has begun shipping a drug for enlarged prostate, the company said Friday.

Mylan announced the launch of alfuzosin hydrochloride extended-release tablets in the 10-mg strength.

The drug is a generic version of Sanofi's Uroxatral, which had sales of about $241 million during the 12-month period ended in June, according to IMS Health.

August 11, 2011

Drug maker Avanir Pharmaceuticals has filed suit against two generic drug makers seeking to launch versions of a drug used to treat pseudobulbar affect, which causes sudden, involuntary episodes of laughing and crying, and occurs secondary to numerous other neurological conditions.

ALISO VIEJO, Calif. — Drug maker Avanir Pharmaceuticals has filed suit against two generic drug makers seeking to launch versions of a drug used to treat pseudobulbar affect, which causes sudden, involuntary episodes of laughing and crying, and occurs secondary to numerous other neurological conditions.

Avanir filed the suit in the U.S. District Court for the District of Delaware against Par and Actavis, which had filed for regulatory approval of Nuedexta (dextromethorphan hydrobromide and quinidine sulfate).

August 10, 2011

The Food and Drug Administration has approved a generic drug for epilepsy.

PISCATAWAY, N.J. — The Food and Drug Administration has approved a generic drug for epilepsy.

Innopharma announced the FDA approval of levetiracetam injection. The drug is a generic version of UCB's Keppra.

Innopharma has a licensing agreement with X-GEN Pharmaceuticals for marketing and distribution of the drug.

August 9, 2011

Profits for Endo Pharmaceutical Holdings rose to $54.6 million during second quarter 2011, up 6% from $51.5 million in second quarter 2010, the drug maker said.

CHADDS FORD, Pa. — Profits for Endo Pharmaceutical Holdings rose to $54.6 million during second quarter 2011, up 6% from $51.5 million in second quarter 2010, the drug maker said.

Sales for the quarter were $607.5 million, compared with $396.5 million in second quarter 2010. Sales of branded drugs were $398.3 million, an 8% increase over last year, which the company attributed to better sales of the pain drug Opana ER and the joint pain drug Voltaren Gel.

August 4, 2011

The Food and Drug Administration has reorganized the Office of Generic Drugs in an effort to improve efficiency, according to an internal memo.

SILVER SPRING, Md. — The Food and Drug Administration has reorganized the Office of Generic Drugs in an effort to improve efficiency, according to an internal memo.

The new organizational scheme will add a new division to the bioequivalence program called Division of Bioequivalence II and a new chemistry division, Division of Chemistry IV.

July 29, 2011

The Food and Drug Administration has approved a generic drug for diabetes made by Indian generic drug maker Strides Arcolab.

BANGALORE, India — The Food and Drug Administration has approved a generic drug for diabetes made by Indian generic drug maker Strides Arcolab.

The FDA approved acarbose tablets in the 25-mg, 50-mg and 100-mg strengths. The drug is a niche drug used to treat Type 2 diabetes, Strides said.

Acarbose tablets have sales of about $21 million, according to IMS Health.

July 28, 2011

Generic drug maker Watson Pharmaceuticals has launched a generic version of a contraceptive made by Duramed Pharmaceuticals, Watson said Thursday.

PARSIPPANY, N.J. — Generic drug maker Watson Pharmaceuticals has launched a generic version of a contraceptive made by Duramed Pharmaceuticals, Watson said Thursday.

Watson announced the launch of Amethia (levonorgestrel and ethinyl estradiol [0.15 mg/0.03 mg] and ethinyl estradiol [0.01 mg]) after the U.S. Court of Appeals for the Federal Circuit denied Duramed’s request for a temporary injunction; a patent infringement lawsuit that Duramed filed against Watson remains pending.

July 26, 2011

Generic drug maker Lupin is seeking approval for a generic version of a contraceptive made by Warner Chilcott, according to published reports.

NEW YORK — Generic drug maker Lupin is seeking approval for a generic version of a contraceptive made by Warner Chilcott, according to published reports.

Reuters reported that Lupin had applied for approval of a generic version of Lo Loestrin Fe (norethindrone acetate and ethinyl estradiol tablets, ethinyl estradiol tablets and ferrous fumarate tablets), an oral contraceptive.

July 25, 2011

Health care is like precision engineering; tweaking one element ever so slightly can mean the difference between a healthy life and an early death or, in the case of drug spending, between nearly $50,000 and just north of $1,000.


Health care is like precision engineering; tweaking one element ever so slightly can mean the difference between a healthy life and an early death or, in the case of drug spending, between nearly $50,000 and just north of $1,000.


July 25, 2011

The Food and Drug Administration has approved a drug made by Johnson & Johnson for treating deep vein thrombosis in patients undergoing knee or hip replacement surgery, a J&J subsidiary said.

SUPPLIER NEWS — The Food and Drug Administration has approved a drug made by Johnson & Johnson for treating deep vein thrombosis in patients undergoing knee or hip replacement surgery, a J&J subsidiary said. Janssen Pharmaceuticals announced the approval of Xarelto (rivaroxaban) tablets as a once-daily oral anticoagulant for DVT, a condition that could lead to pulmonary embolism.


July 22, 2011

The National Association of Chain Drug Stores announced Thursday that it has submitted comments to the U.S. Senate Special Committee on Aging outlining the value of the pharmacist-patient interaction in helping improve health and reduce costs in the Medicare program, and urged the committee to support the Medication Therapy Management Empowerment Act of 2011, which seeks to increase access to pharmacy services for Medicare beneficiaries.

ALEXANDRIA, Va. — The National Association of Chain Drug Stores announced Thursday that it has submitted comments to the U.S. Senate Special Committee on Aging outlining the value of the pharmacist-patient interaction in helping improve health and reduce costs in the Medicare program, and urged the committee to support the Medication Therapy Management Empowerment Act of 2011, which seeks to increase access to pharmacy services for Medicare beneficiaries.

July 22, 2011

Bipartisan legislation recently introduced to the Senate has received endorsement from a group representing the retail pharmacy industry.

ALEXANDRIA, Va. — Bipartisan legislation recently introduced to the Senate has received endorsement from a group representing the retail pharmacy industry.

July 19, 2011

New bipartisan legislation introduced to the Senate last week seeks to offer states incentives to use generic drugs by allowing states to temporarily keep a portion of the savings.

WASHINGTON — New bipartisan legislation introduced to the Senate last week seeks to offer states incentives to use generic drugs by allowing states to temporarily keep a portion of the savings.

Senators Scott Brown, R-Mass.; Ron Wyden, D-Ore.; and John McCain, R-Ariz., introduced the Affordable Medicines Utilization Act of 2011, saying that the bill would encourage states to take advantage of cost-saving generic drugs.

July 19, 2011

Generic drug maker Teva recently admitted that one of its drugs infringes two of Amgen's patents.

THOUSAND OAKS, Calif. — Generic drug maker Teva recently admitted that one of its drugs infringes two of Amgen's patents.

The U.S. District Court in Pennsylvania has barred Teva from selling its human G-CSF (human granulocyte colony-stimulating factor) product Neutroval in the United States until Nov. 10, 2013. What's more, the court's injunction extends to Teva's other human G-CSF product, Neugranin. Teva will not sell Neugranin until Nov. 10, 2013, unless it first obtains a final court decision that Amgen's patents are not infringed by Neugranin.

July 11, 2011

Generic drug maker Amneal has launched three new liquid drugs, the company said Monday.

BRIDGEWATER, N.J. — Generic drug maker Amneal has launched three new liquid drugs, the company said Monday.

July 8, 2011

Watson Pharmaceuticals has filed with the Food and Drug Administration for regulatory approval for a drug to treat attention deficit hyperactivity disorder, the company said Thursday.

PARSIPPANY, N.J. — Watson Pharmaceuticals has filed with the Food and Drug Administration for regulatory approval for a drug to treat attention deficit hyperactivity disorder, the company said Thursday.

Watson said it submitted its application for lisdexamfetamine dimesylate capsules, a generic version of Shire’s Vyvanse.