International
Par Pharma's nausea drug gets FDA approval PDF Print E-mail
International

 

July 3, 2010

Par Pharmaceutical Cos Inc (PRX.N) said U.S. health regulators have approved its drug to prevent nausea and vomiting in patients who are treated for cancer.

The drug Zuplenz, in form of an oral soluble film, is a formulation of ondansetron, which is currently marketed by GlaxoSmithKline (GSK.L) (GSK.N) under the brand name Zofran.

Strativa Pharmaceuticals, a division of Par's unit, is expected to launch Zuplenz, in 4 mg and 8 mg dosage strengths, in the third quarter.

The company, which uses Monosol RX's oral soluble technology to deliver the drug, said it would pay the partner a milestone payment of $4.0 million on the approval and $2 million as a pre-launch milestone.

 

 
FDA to Collaborate with Pharma Companies on New TB Initiative PDF Print E-mail
International
Sunday, 21 March 2010 00:00

The U.S. Food and Drug Administration unveiled a new initiative to accelerate the development of cocktail drugs to treat tuberculosis (TB).

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Lupin gets tentative USFDA approval for PDF Print E-mail
International
Sunday, 21 March 2010 00:00

 Lupin received a US Food and Drug Administration tentative approval for an insomnia drug, the company told pharmaquest.biz. This is Lupin’s second approval this week and sixth this year.

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Glenmark gets USFDA nod for anti-hypertension tablet PDF Print E-mail
International
Sunday, 21 March 2010 00:00

 

 Glenmark Pharmaceuticals today said its American subsidiary has received the final approval from the US Food and Drug Administration (FDA) for Moexipril Hydrochloride tablets used for treating hypertension.

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