Content about Racetams

July 26, 2012
Qualitest gets FDA OK for generic Keppra XR

Qualitest Pharmaceuticals announced that it has received approval from the Food and Drug Administration for its generic version of an epilepsy treatment.

HUNTSVILLE, Ala. — Qualitest Pharmaceuticals announced that it has received approval from the Food and Drug Administration for its generic version of an epilepsy treatment.

The drug maker said its abbreviated new drug application for levetiracetam extended-release tablets, in the 500-mg and 750-mg strength, was approved. The drug is a generic version of UCB's Keppra XR.

Total combined sales for levetiracetam extended-release tablets were approximately $124.8 million for the 12 months ended in May, according to IMS Health data.

February 29, 2012
FDA approves Hi-Tech Pharmacal epilepsy drug

The Food and Drug Administration has approved a drug for epilepsy made by Hi-Tech Pharmacal, the drug maker said Wednesday.

AMITYVILLE, N.Y. — The Food and Drug Administration has approved a drug for epilepsy made by Hi-Tech Pharmacal, the drug maker said Wednesday.

Hi-Tech announced the approval of levetiracetam oral solution in the 100 mg-per-milliliter strength. The drug is a generic version of UCB Pharma's Keppra oral solution and is used to treat partial onset seizures in people ages 16 years and older.

Various versions of the drug had sales of $62 million in 2011, according to IMS Health. Hi-Tech said it plans to launch the drug in May.

January 3, 2012
FDA approves Mylan epilepsy drug

The Food and Drug Administration has approved a drug for epilepsy made by Mylan, the drug maker said.

PITTSBURGH — The Food and Drug Administration has approved a drug for epilepsy made by Mylan, the drug maker said.

The FDA approved Mylan's levetiracetam extended-release tablets in the 500-mg and 750-mg strengths.

The drug is a generic version of UCB's Keppra XR, used to treat partial onset seizures in epilepsy patients ages 16 years and older.

Various versions of the drug had sales of about $162.8 million during the 12-month period ended in September, according to IMS Health.

October 4, 2011
Report: Lupin stands to benefit from drug patent expiries

A wave of patent expirations over the next several years will open up a broad swath of drugs to generic competition, and India's Lupin Pharmaceuticals is looking to benefit, according to published reports.

NEW YORK — A wave of patent expirations over the next several years will open up a broad swath of drugs to generic competition, and India's Lupin Pharmaceuticals is looking to benefit, according to published reports.

The Wall Street Journal reported that the Mumbai-based company planned to launch 25 to 30 new generic drugs each year over the next couple of years.

September 15, 2011
Lupin launches generic epilepsy drug

The Food and Drug Administration has approved a generic drug for epilepsy made by Lupin Pharmaceuticals, the drug maker said.

BALTIMORE — The Food and Drug Administration has approved a generic drug for epilepsy made by Lupin Pharmaceuticals, the drug maker said.

Lupin announced the approval and launch of levetiracetam extended-release tablets in the 500-mg and 750-mg strengths.

The drug is a generic version of UCB's Keppra XR, which had sales of about $161 million during the 12-month period ended in June, according to IMS Health.

August 10, 2011
Innopharma gets FDA nod for epilepsy generic

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.

February 1, 2010
Taro gets go-ahead for epilepsy drug

The Food and Drug Administration has approved a generic epilepsy drug made by Taro Pharmaceutical...