March 2012 | Volume 11 | Issue 3 | Features | 423 | Copyright © March 2012
Pipeline Previews brings to you information on the newest drugs and medical products as they become available to the dermatologic community. This department may include additional information from the manufacturers, plus reports from physicians who wish to share their clinical experience with these new products. In addition, we will inform our readers about the latest drugs receiving Food and Drug Administration (FDA) approval.
FDA Requires Follow-Up on TNF blocker
The FDA has announced that it is requiring that manufacturers
of tumor necrosis factor (TNF) blockers perform enhanced safety
surveillance in children, teenagers, and young adults (aged 30
years or younger) treated with TNF blockers. Manufacturers of
TNF blockers are required to follow up on reports of malignancy
cases involving TNF blockers and submit all reports of malignancy to FDA as expedited reports. Manufacturers are also
required to provide annual summaries and assessments of ma-
lignancies and TNF blocker utilization data to the FDA under the
Health care workers are also directed to report cases of malignancy in patients treated with TNF blockers to the FDA MedWatch
program or manufacturer.
The FDA or the manufacturer may ask healthcare workers for
additional clinical and diagnostic information related to the
malignancy cases. This information may include: patient characteristics (age, gender, no patient identifiers); risk factors for
malignancy; exposure to other immune suppressing products
or products with risk of malignancy; indication for TNF blocker treatment; TNF blocker exposure (duration, dose); cancer
diagnosis (date of diagnosis, stage); biopsy results; and/or outcomes of malignancy (treatments, event outcome).
Allergan Plans Botox Manufacturing Expansion
Allergan has announced that it will invest $350 million to expand its manufacture of the anti-wrinkle drug Botox in the west
of Ireland. The expansion will create 200 new jobs over the next
four years, bringing Allergan's total Irish workforce to 1,100.
Allergan states that recent approvals of Botox for use in treating migraine headaches and overactive bladders is expected to
increase demand for the product.
Aqua Pharmaceuticals Acquires FLUOROPLEX
Aqua Pharmaceuticals, LLC has announced the acquisition of
FLUOROPLEX® (fluorouracil) 1% Topical Cream from Allergan
Inc. FLUOROPLEX is a topical cream indicated for the treatment
of multiple actinic keratoses. Aqua sees the new acquisition as a
complement to its existing line of CORDRAN® (flurandrenolide)
topical steroids, MONODOX® (doxycycline monohydrate capsules)
oral antibiotics, and XOLOGEL® (ketoconazole USP) Gel, 2%.
Alpharma Launches Clotrimazole and Betamethasone
Dipropionate Topical Cream
Alpharma Inc. has announced the launch of its product clotrimazole & betamethasone dipropionate (BMD) topical cream in the
United States. Clotrimazole & BMD cream is the generic equivalent of Lotrisone® cream, a registered trademark of the Schering
Generic Equivalents of Clobex
Actavis Group has announced that it has begun shipping Clobetasol Propionate Shampoo and Clobetasol Propionate Lotion, generic
equivalents to Galderma's Clobex® Shampoo and Clobex Topical
Lotion. Due to Actavis' first-to-file status, the FDA has granted
Actavis a 180-day marketing exclusivity.
Phase 3 Trial of PV-10 For Metastatic Melanoma
In response to Provectus Pharmaceuticals, Inc's request for a final end-of-Phase 2 meeting with the FDA to achieve consensus
on design of a planned pivotal Phase 3 randomized controlled
trial of PV-10 for metastatic melanoma, the FDA has directed
Provectus to submit its Phase 3 protocol for review, either via
standard review or a request for Special Protocol Assessment
("SPA"). The FDA decided that an end-of-Phase 2 meeting with
Provectus is not required. Provectus intends to pursue the SPA
path, which would represent an agreement from the FDA that
the Phase 3 study design endpoints, statistical analyses and
other components of the planned clinical trials are acceptable
to support approval of the product.