Product news from the 10/10/06 News Brief

Share this article:
Merck said today that the FDA has approved oral Zolinza (vorinostat) for the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma, a form of non-Hodgkin's lymphoma, who have progressive, persistent or recurrent disease on or following two systemic therapies. CTCL is a cancer of the T-cells, a type of white blood cell, which affects the skin. The FDA has approved GlaxoSmithKline’s FluLaval (influenza virus vaccine) for immunization of adults 18 years and older against influenza disease, commonly known as the flu. The FDA approved Berlex’s Yaz (drospirenone/ethinyl estradiol) for the treatment of the emotional and physical symptoms of premenstrual dysphoric disorder (PMDD) in women who choose to use an oral contraceptive as their method of contraception. YAZ received initial FDA approval for the prevention of pregnancy in March 2006. Sepracor said the FDA has approved its new drug application for Brovana (arformoterol tartrate) as a long-term, maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. Genentech and Biogen Idec received FDA approval for two additional uses for Rituxan (rituximab) for patients with CD20-positive, B-cell non-Hodgkin's lymphoma (NHL). One new indication for Rituxan is for first-line treatment of previously-untreated patients with follicular NHL in combination with CVP (cyclophosphamide, vincristine and prednisolone) chemotherapy. The second new indication is for the treatment of low-grade NHL in patients with stable disease or who achieve a partial or complete response following first-line treatment with CVP chemotherapy.
Share this article:
You must be a registered member of MMM to post a comment.
close

Next Article in Business Briefs

Email Newsletters

MM&M EBOOK: PATIENT ACCESS

Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Business Briefs

Novartis said to be stepping out of HCV

Novartis is said to have relinquished rights to an investigational hep. C treatment, signaling its exit from the therapeutic space, according to a former partner's announcement.

Monday Moves: September 15

Hires and promotions for manufacturers, regulatory and agencies

Kantar acquires Evidências, expands Brazilian presence

The company's acquisition signals the growing importance of understanding the Brazilian healthcare market and evidence-based healthcare management services.