SANDOZ SETTLES WITH MYLAN ON THIORIDAZINE PROMOTIONS: the settlement "marks the first successful attack by a generic manufacturer against a pioneer manufacturer for Sherman Act [anti-trust] violations of this sort," Mylan said in an April 2 release announcing the settlement. Mylan said that its suit against Sandoz has been settled by an agreement that involves payment by Sandoz to Mylan of "a substantial sum of money." Terms of the settlement prohibit disclosure of the amount of payment. In its suit, Mylan had sought approximately $10 mil. in compensatory and punitive damages. Mylan's suit against Sandoz was initiated in the spring of 1984, one year after Mylan received FDA approval to market thioridazine HCl products. The suit, filed by counsel Andrew Fusco (Morgantown, WV firm Fusco & Newbraugh), alleged that Sandoz attempted to "arbitrarily, unlawfully, unreasonably and knowingly prevent, suppress and eliminate competition from other competitors and prospective competitors of Sandoz in the sale of thioridazine HCl in interstate commerce." Sandoz did this, Mylan asserted, by disseminating information to formulary approval boards, retail pharmacists, governmental purchasing agents, and physicians that "contained express misrepresentations as to the pharmacokinetic properties of [Sandoz' thioridazine product] Mellaril." Sandoz' original filing in response to the suit denied Fusco's allegations that the material distributed was "designed to, and did, misinform, mislead and confuse the recipients thereof as to the true characteristics of Mellaril, particularly as compared to Mylan's thioridazine HCl." Settlement of the suit follows FDA objections to a letter Sandoz sent pharmacists in May 1984. The Sandoz letter requested information on observed adverse drug reactions after substitution of generic thioridazine for Mellaril. In a Sept. 5 letter to Sandoz, FDA told the firm that it viewed the "Dear Pharmacist" letter as an antigeneric campaign attempting "to mislead health care professionals to believe that substituting approved generic forms of thioridazine to patients requiring such will result in clinical failures or some other unexpected and unfortunate experience" ("The Pink Sheet" Oct. 7, T&G-4). At FDA's request, Sandoz sent a follow-up letter to pharmacists in January stating that current data is "inconclusive regarding any clinical differences" between Mellaril and generic thioridazine ("The Pink Sheet" Jan. 20, T&G-1).
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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