Watson seeks FDA approval for sleep disorder treatment
MORRISTOWN, N.J. Watson has filed an abbreviated new drug application for the generic version of a sleep disorder treatment.
Watson said is seeks approval for market its 50-mg, 100-mg, 150-mg, 200-mg, and 250-mg strength armodafinil tablets prior to the expiration of patents owned by Cephalon France. Watson’s drug is the generic version of Nuvigil, which is indicated for the improvement of wakefulness in adults who experience excessive sleepiness associated with treated obstructive sleep apnea, shift work sleep disorder, also known as shift work disorder, or narcolepsy.
Cephalon and Cephalon France filed suit against Watson on Jan. 5, 2010 in the U.S. District Court for the District of Delaware seeking to prevent Watson from commercializing its product prior to the expiration its patent. Based on available information, Watson said it believes it may be a “first applicant” to file an ANDA for the 100-mg and 200-mg strengths of a generic version of Nuvigil and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity for those strengths.
For the twelve months ended Sept. 30, 2009, Nuvigil had total U.S. sales of approximately $42 million according to IMS Health data.
Report: Cipla in generic drug supply talks with GSK, Teva
NEW YORK An India drug maker is in generic drug supply talks with two companies, according to reports.
Cipla said it is in talks with GlaxoSmithKline and Teva to supply the companies with generic drugs.
“It may be specifically for one or two products — it is not a down-the-line drug deal,” Cipla chairman Yusuf Hamied told Reuters.
Cipla is one of the world’s biggest producers of low-cost antiretroviral drugs to fight HIV and AIDS. Last month, the company announced the launch of a generic H1N1 treatment.
Taro elects directors in shareholders meeting; Sun disapproves
HAWTHORNE, N.Y. An Israeli drug maker said that its shareholders voted to elect all of the directors who were up for election, with the exception of the statutory external directors, at its annual shareholders meeting held Dec. 31.
The shareholders also approved the ratification of indemnification for non-executive directors and the appointment of the Taro’s independent auditors.
The company said that it stands behind its nominees for statutory external directors and their qualifications, and further stated that it would continue its efforts to elect statutory external directors as required by Israeli law, despite the efforts of Sun Pharmaceutical Industries to block their election. Sun has claimed that Barrie Levitt, Taro’s chairman, signed contractual obligation to sell Taro’s shares to Sun at a pre-defined price in June 2008. Sun said, however, that Levitt and the company “have prevented the close of this transaction through improper use of Taro resources.”
Sun has sought to acquire Taro for some time. In August 2008, Sun’s tender offer to acquire the company expired, but said that it would once again seek to acquire Taro. In late September, Taro sued Sun in the U.S. District Court for the Southern District of New York, alleging that Sun failed to disclose information to Taro shareholders, and misappropriating confidential information about Taro as part of its efforts to acquire the company – which it has sought to do since June 2008 – and illegally using it to undermine Taro’s relationships with customers and revenues.