Generics

PITTSBURGH The Food and Drug Administration has approved a Mylan generic drug for Parkinson’s disease, Mylan said Thursday.

 

The drug maker announced the approval of pramipexole dihydrochloride tablets in the 0.125-mg, 0.25-mg, 0.5-mg, 1-mg and 1.5-mg strengths. The drug is a generic version of Boehringer Ingelheim’s Mirapex.

 

 

BETHESDA, Md. The Food and Drug Administration could decide that some generic drugs are not equivalent to their branded counterparts, according to published reports.

 

ST. LOUIS K-V Pharmaceutical has created a new marketing subsidiary for generic drugs, the company said Wednesday.

 

K-V announced the establishment of Nesher Pharmaceuticals, appointing as its president Mark Hartman, who has had several positions in generic drug companies.

 

 

HYDERABAD, India Dr. Reddy's disclosed on Tuesday it will market a generic peptic ulcer treatment.

Dr. Reddy's lansoprazole delayed-release capsules will be available in 15-mg and 30-mg strengths, the drug maker said. The capsules are the generic version of Takeda's Prevacid delayed-release capsules.

The FDA approved Dr. Reddy’s abbreviated new drug application for the drug on Oct. 15.

MORRISTOWN, N.J. The Food and Drug Administration has approved a drug for treating insomnia made by Actavis, the generic drug maker said Monday.

 

Actavis announced the approval of zolpidem tartrate extended-release tablets in the 6.25-mg strength. The company has begun shipping the drug.

 

 

The drug is a generic version of Sanofi-Aventis’ Ambien CR, which had sales of around $129 million during the 12-month period ended in June, according to IMS Health.

 

JERUSALEM The Food and Drug Administration granted approval for Teva's abbreviated new drug application to market a generic version of a drug designed to treat peptic ulcers.

The generic drug maker said that its drug, lansoprazole, is a generic version of Takeda’s Prevacid SoluTab. Annual sales of the branded product were approximately $453 million in the United States, according to IMS sales data.

Sandoz, the generics division of Swiss drug maker Novartis, also announced the launch of its own version of Prevacid SoluTab.

PITTSBURGH The Food and Drug Administration has approved two generic drugs by Mylan for treating hypertension, Mylan said Friday.

 

The company announced the approval of losartan potassium and hydrochlorothiazide tablets in the 50/12.5-mg and 100/25-mg strengths, and losartan potassium tablets in the 25-mg, 50-mg and 100-mg strengths, generic versions of Merck’s Hyzaar and Cozaar, respectively. Mylan began marketing its version of Hyzaar in the 100/12.5-mg strength in April.

 

 

MORRISTOWN, N.J. The Food and Drug Administration has approved a Watson Pharmaceuticals generic drug for treating high blood pressure, Watson said Friday.

 

The company announced the FDA approval of amlodipine besylate and benazepril capsules in the 5/20-mg, 10/20-mg, 2.5/10-mg and 5/10-mg strengths.

 

 

The drug is a generic version of Novartis’ Lotrel. Branded and generic versions of the drug had sales of around $1.05 billion during the 12-month period ended in June, according to IMS Health.