FDA Requires Follow-Up on TNF blocker Malignancy Cases
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 new guidelines.
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 in Ireland
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 Plough Corporation.
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.