FDA Assigns Drug Master File to European Cancer Group

FDA assigns drug master file to European cancer group.

Dr. Gregory R. Mundy Texas, San Antonio, but they also decrease the number of tumor cells that are in bone, and "we guess they do that by changing the bone environment and making the bone a less hospitable place for the cancer cells to grow." The majority of breast cancer patients in whom cancer has spread beyond its primary origin experience metastases to bone. For these patients, a loss in bo...

FDA approves new drug to treat dementia.

Actavis and Adamas Pharmaceuticals, Inc., announced that the U.S. Food and Drug Administration has approved the New Drug Application for NamzaricTM for the treatment of moderate to severe dementia of the Alzheimer’s type in patients stabilized on memantine hydrochloride and donepezil hydrochloride. Namzaric will be available in two dosage strengths: 28/10 mg (memantine extended release/donepezi...

FDA to review "missing" drug company documents.

Drug maker urges group to lobby FDA on testosterone for women.

1255 The major household products manufacturer Procter & Gamble recently sought support from an international medical society, which it sponsors, asking the group to get involved in a regulatory hearing assessing the company’s experimental testosterone patch. No peer reviewed data on the testosterone patch have been published, but it has been granted a fast track review by the US Food and Drug ...

FDA drug approval summaries: fulvestrant.

Patients with hormone-sensitive breast cancer who have responded to tamoxifen may receive additional benefit from a second endocrine agent following progression or relapse after tamoxifen therapy. Fulvestrant (Faslodex((R)), ICI 182780, AstraZeneca Pharmaceuticals; Wilmington, Delaware) is a selective antagonist of estrogen designed to have no estrogenic effects. Lack of aqueous solubility led ...