PHARMACY

FDA approves generic Lorazepam Intensol

BY Alaric DeArment

HAUPPAUGE, N.Y. The Food and Drug Administration has approved a generic drug for anxiety disorder made by Amneal Pharmaceuticals, Amneal said Wednesday.

The FDA approved lorazepam oral concentrate, a generic version of Roxane Labs’ Lorazepam Intensol, in the 2-mg-per-mL strength. The drug is a schedule IV controlled substance. Amneal said it received approval to manufacture the drug in December 2009 and began shipping it in March. The drug is sold as a clear, flavorless liquid that can be mixed with other liquids or semisolid food.

“Launching lorazepam oral concentrate adds yet another capability to Amneal’s distribution organization – refrigerated shipping,” Amneal EVP sales and marketing Jim Luce said. “This also offers a nice expansion to our aggressively growing liquid products portfolio, all generated from our Branchburg, N.J., liquids plant.”

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Intellipharmaceutics files new drug application for generic Protonix

BY Allison Cerra

TORONTO Intellipharmaceutics has filed an abbreviated new drug application for a generic drug designed to treat gastrointestinal issues, the drug maker said.

Intellipharmaceutics said its pantoprazole sodium delayed-release tablets — a generic version of Protonix — inhibits gastric acid secretion and is prescribed for the short-term treatment of such conditions as stomach ulcers associated with gastroesophageal reflux disease as well as the long term treatment of pathological hypersecretory conditions including Zollinger-Ellison syndrome.

Sales of pantoprazole sodium delayed-release tablets in the United States were approximately $1.8 billion in 2009.

“I am extremely pleased with the progress we continue to make with the advancement of our product pipeline,” said Isa Odidi, Intellipharmaceutics CEO. “Protonix is the second ANDA we have filed with the FDA this year and, together with Focalin XR and Effexor XR, it represents another potential source of future revenue from our company’s ANDA pipeline.”

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Injunction blocks Dr. Reddy’s generic Allegra D24

BY Alaric DeArment

NEW YORK A U.S. District Court has granted French drug maker Sanofi-Aventis and Albany Molecular Research an injunction halting the launch of a generic version of one of its drugs made by Dr. Reddy’s Labs, Dr. Reddy’s said.

The U.S. District Court for the District of New Jersey blocked the release of Dr. Reddy’s fexofenadine hydrochloride and pseudoephedrine hydrochloride extended-release tablets in the 180 mg and 240-mg strength, a generic version of Allegra D24, marketed by Sanofi-Aventis and discovered by Albany Molecular Research.

Dr. Reddy’s said it strongly disagreed with the lawsuit and intended to appeal. According to published reports, the Food and Drug Administration had approved Dr. Reddy’s version of the drug following a 30-month stay of approval resulting from a patent infringement lawsuit filed against the company when it tried to seek approval for the generic. The last patents covering Allegra D24 expire in December 2020.

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