CONTACT: Sarah Fait, (202) 778-8439, sfait@zuckerman.com
Washington, D.C.—May 19, 2008Zuckerman Spaeder LLP client Roxane Laboratories, Inc.
secured an important victory in the first case testing the generic exclusivity forfeiture provisions of the Federal Food, Drug and Cosmetic Act (FDCA). In a May 9 ruling, the United States District Court for the District of Columbia declined to issue a temporary restraining order that would have forced Roxane to stop marketing its just-approved version of the drug acarbose, used to treat Type II diabetes. On May 16, the case was voluntarily dismissed by the plaintiff, Cobalt “This is not just a victory for Roxane, but in this time of soaring healthcare costs it is also a victory for American consumers, who will benefit from vigorous competition in the generic pharmaceuticals marketplace,” said Zuckerman Spaeder partner William B. Schultz.
In the suit, Cobalt challenged the decision of the Food and Drug Administration (FDA) to approve Roxane’s application for acarbose at the same time as it approved Cobalt’s application. FDA had approved Roxane’s application after concluding that Cobalt had forfeited its right to 180 days of generic exclusivity by failing to market its product within 30 months of submitting its application. Cobalt, however, claimed it was still entitled to 180-day exclusivity. Roxane intervened to protect its interest in the case. Cobalt sought an order that would have required Roxane to stop selling its product while Cobalt remained on the market. In its ruling, the court agreed with FDA and Zuckerman Spaeder that, under the plain language of the FDCA, Cobalt was unlikely to prevail in the case and also that Roxane would suffer significant competitive injury from a temporary restraining order. Mr. Schultz, on behalf of Roxane, advocated that the temporary restraining order requested by Cobalt be denied because it would not freeze the “status quo”; rather, it would allow Cobalt to secure significant market advantages as the only generic seller of acarbose. “The impact of this decision will shape how generic companies respond to the forfeiture provisions and underscore the need for generic companies to diligently pursue FDA approval of their applications,” said Mr. Schultz. Mr. Schultz was assisted in this representation by partner Alexandra W. Miller, counsel Andrew N. Goldfarb and associate Lisa L. Barclay. Founded in 1975, Zuckerman Spaeder has more than 105 attorneys and specializes in the areas of complex commercial and criminal litigation, and food and drug law. The firm is “AV” rated by Martindale-Hubbell and has offices in Washington, DC; New York; Tampa; Baltimore; and Wilmington, DE. In 2005, the firm was named a top five litigation boutique by The American Law

Source: http://www.zuckerman.com/media/news/33_Roxane%20Exclusivity%20Win%20Press%20Release%200508.pdf

June pre-hospital 2010

Meeting minutes from May approved. Dates for agency run reviews need to be finalized. Tish will send out the schedule that was previously created with the month each agency requested. Each agency needs to give a couple possible dates to schedule so a date can be confirmed with Dr Burns schedule. Patch format: 1 set of vitals for a BLS refusal is acceptable. 2 sets of vitals are required


The 43rd Finnish Aesthetic Teaching SymposiumTel. +358 9 2525 4242, info@siluetti.fiwww.siluetti.fiThe 43rd Finnish Aesthetic Teaching SymposiumMain topic: HAIR RESTORATION SURGERY• Learn the surgical technique of micrografts and minigrafts including planning, harvesting the donor • manage difficult cases and complicationsAlfonso Barrera, M.D., F.A.C.S., Plastic Surgeon, Otolaryngologist,

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