New products: January 14, 2008


Coverage of branded drugs, new indications, new formulations, new dosages, along with OTCs.



Novartis Pharmaceuticals, East Hanover, N.J., (862) 778-8300, has secured FDA approval for Tasigna (nilotinib) Capsules. The drug has been approved for the treatment of chronic-phase and accelerated-phase Philadelphia chromosome-positive chronic myeloid leukemia patients who are resistant or intolerant to prior therapy that included Novartis' Gleevec Tablets.


Bayer HealthCare Pharmaceuticals, Wayne, N.J., (973) 694-4100, along with Onyx Pharmaceuticals, Emeryville, Calif., (510) 597-6500, has received FDA approval for a new indication for Nexavar (sorafenib) Tablets. Originally approved for advanced kidney cancer, the oral anticancer drug is now used in the treatment of patients with unresectable hepatocellular carcinoma (primary liver cancer).

Sanofi-aventis, Bridgewater, N.J., (908) 243-6000, and Bristol-Myers Squibb, Princeton, N.J., (609) 252-4000, have received FDA approval for a new indication for Avalide (irbesartan/hydrochlorothiazide). The antihypertensive drug is now indicated for initial use in patients likely to need multiple drugs to lower their blood pressure.


Sprycel (dasatinib) is an oral inhibitor of multiple tyrosine kinases for the treatment of adults in all three phases of chronic myeloid leukemia (CML) with resistance or intolerance to prior therapy. Bristol-Myers Squibb has received FDA approval for new labeling that includes a lower recommended starting dose of 100 mg once daily. The lower dose reduces the incidence of some side effects while still preserving the efficacy of the drug for chronic-phase CML patients who no longer respond to other approved therapies.


EMD Serono, U.S. affiliate of Geneva-based Merck Serono, has received FDA approval for easypod, a new delivery system for the subcutaneous administration of Saizen, a treatment for growth hormone deficiency. The device is to be used in conjunction with Saizen click.easy cartridges. The company can be reached in Rockland, Mass., at (800) 283-8088.

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