Mylan challenges FDA ruling on celecoxib
PITTSBURGH — Mylan last week announced that it filed suit against the Food and Drug Administration, challenging the agency’s decision regarding generic drug marketing exclusivity on celecoxib capsules, the generic equivalent of Pfizer’s Celebrex.
Mylan believes that the agency was misguided in its decision in the case and maintains that it is in a position to receive final approval on May 30 when Celebrex’s remaining patents expire. Other companies have settled for a December 2014 launch date and will be unable to launch on May 30.
"We believe the FDA has made an unprecedented error in this case which clearly caught all industry participants off guard, as evidenced by some who have already settled with Pfizer for December 2014 launch dates, which is post patent expiry. Mylan seeks an order compelling FDA to grant final approval of Mylan’s ANDA on May 30, 2014," said Heather Bresch, Mylan CEO.
Sandoz announces generic Differin gel
PRINCETON, N.J. — Sandoz on Monday announced the introduction of its adapalene 0.3% gel, a generic version of Differin gel, 0.3% from Galderma Labs. Adapalene gel is a retinoid and is used for the topical treatment of acne vulgaris in patients ages 12 years and older.
"Sandoz is proud to market a high-quality, affordable generic version of this important topical therapy,” said Peter Goldschmidt, president of Sandoz U.S. “This launch further broadens our strong offering of differentiated generic dermatology products in the United States.”
Sandoz will market the gel through a collaboration with Tolmar Inc., which owns the abbreviated new drug application for the product and was the first company to receive FDA approval for a generic equivalent.
Sandoz will market the adapalene 0.3% gel in 45 gram tubes. U.S. sales for Differin gel 0.3% in 45-g tubes was approximately $87 million for the 12 months ending December 2013, according to IMS Health.
McKesson Specialty Health integrates distribution services
THE WOODLANDS, Texas & SUMMIT, N.J. — McKesson Specialty Health, a division of McKesson Corp., last week announced the integration of its distribution services with General Medical Services' Physician Office Drug Inventory System. The alliance creates the first end-to-end integrated iventory and order-to-reimbursement verification solution designed for ophthalmologists.
“Integrating our extensive services with the feature-rich PODIS system gives ophthalmology practices a powerful end-to-end solution to support and optimize business health,” said Shawn Seamans, VP and general manager of multi-specialty for McKesson Specialty Health. “Ophthalmologists and their staff now have seamless access to key pharmaceuticals at competitive prices with simplicity, accuracy and transparency every step of the process. This gives practices more control than ever before while reducing costly staff time devoted to ordering, inventory management and payment verification. We are pleased to join with General Medical Services (GMS) to offer this innovative solution that will help keep our mutual customers at the forefront of excellent, efficient quality care,” he added.
Ophthalmology providers will now be able to take advantage of numerous benefits under the new integrated inventory solution, which includes increased efficiency with automated ordering functionality as well as real time order tracking and direct payment.
“Drug inventory control has become an important aspect of ophthalmology practice management. As the leading inventory management solution provider in ophthalmology, we are excited to offer this unique solution with McKesson Specialty Health," GMS CEO Steven Madreperla, MD, PhD said. " For the first time, ophthalmology providers have seamless access to a full spectrum of specialty drugs through an optimized system that tracks each dose from order to payment receipt, taking drug management to new levels of performance. We are confident this will result in overall cost savings to the practice."