December 2011 | Volume 10 | Issue 12 | Features | 1478 | Copyright © December 2011
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.
Cardium Announces FDA 510(k) Clearance
Cardium Therapeutics has announced that it has received 510(k) clearance from the FDA to market and
sell Cardium's ExcellagenTM professional-use. Excellagen is a highly refined fibrillar flowable bovine collagen topical gel (2.6%). It will be marketed as a sterile, syringe-
based advanced wound care product for the management of diabetic foot ulcers and other dermal wounds following surgical debridement procedures. Excellagen is designed to be
used immediately following surgical debridement.
In addition to diabetic foot ulcers, Excellagen is also cleared for use in the management of other dermal
wounds including partial and full-thickness wounds, pressure ulcers, venous ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts,
post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns and skin tears) and draining wounds.
Excellagen, intended for use at one- to two-week intervals following surgical debridement (with weekly outer
dressing changes), will initially be supplied in the form of a kit consisting of four sterile, pre-filled, ready to use single-use syringes, each containing 0.5 cc of
Excellagen formulated collagen topical gel (2.6%), and four sterile flexible applicators to facilitate topical administration to the wound site over a course of up to four
Cardium distinguishes Excellagen from other products by pointing out that other collagen-based products
include granulated collagens that require mixing prior to use, as well as a variety of sheet-based products.
CoreRx Introduces Xcelodose
CoreRx Pharmaceuticals has added an Xcelodose® precision powder micro-dosing system to its product
development capabilities in response to client requirements for pre-clinical and early phase clinical supply. CoreRx advertises that for simple formulations of API or powder-
in-capsule, the Xcelodose system can significantly reduce processing time and API usage resulting in cost savings when compared to hand-filling options.
The Xcelodose system is a precision powder micro-doser and automated encapsulator that has the ability to
fill formulations or API directly into capsules with a high level of accuracy. The Xcelodose system can dispense amounts as low as 100 micrograms and up to 100 milligrams and
beyond, into capsules from size 00 to size 9. Dosing directly into capsules can reduce the amount of API required. Additionally, the unit minimizes overall development time by
simplifying analytical and stability protocols.
Sagent Pharmaceuticals Announces U.S. FDA Approval
Sagent Pharmaceuticals, Inc. has announced that the FDA has approved its bupivacaine hydrochloride injection,
USP — a local or regional anesthetic. Sagent's bupivacaine will be available in six single-dose and two multi-dose latex-free vials.
Bupivacaine hydrochloride is indicated for the production of local or regional anesthesia or analgesia for
surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures.
Helix Biopharma Corp. Files Clinical Hold Response
Topical Interferon Alpha-2b is Helix Biopharma's most advanced product in development incorporating its
proprietary BiphasixTM> drug delivery technology and is designed to offer a superior means of delivering interferon-alpha-2b therapeutically to human papillomavirus
(HPV)-infected tissues. The FDA has placed a "clinical hold" on Helix BioPharma's pending topical interferon alpha-2b, phase 2/3 low- grade cervical lesion efficacy trial
investigational new drug application. Helix Biopharma has announced that it has filed its complete response to the "clinical hold" issues previously raised by the FDA. The
review process typically requires 30 days, during which time the FDA will decide if an applicant is permitted to proceed with its proposed clinical trial.
New Drug Application for Yaupon's Mechlorethamine Hydrochloride
Yaupon Therapeutics, Inc., has
announced that the FDA has accepted the filing of a New Drug Application (NDA) for its