Mylan Subsidiary Wins FDC Approval, Peregrine Reports Cotara Progress: Healthcare Business Recap
In a Wednesday release, Mylan (NASDAQ:MYL) said that its subsidiary, Mylan Pharmaceuticals, has won final FDA approval for its Abbreviated New Drug Application for Candesartan Cilexetil and Hydrochlorothiazide tablets in 16/12.5 mg, 32/12.5 mg and 32/25 mg. The medication is the generic version of AstraZeneca’s (NYSE:AZN) Atacand HCT and is indicated for the treatment of hypertension.
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Peregrine Pharmaceuticals (NASDAQ:PPHM) announced in a release on Wednesday it has made significant progress in advancing its Cotara program into late-stage development through its agreement with the FDA on the design of a single registration trial for Cotara in patients suffering from recurrent glioblastoma multiforme. Further, the agency agrees with the firm’s proposed randomized trial design comparing two dose levels of Cotara in up to 300 patients.
AcelRx Pharmaceuticals (NASDAQ:ACRX) announced through a Wednesday release a proposed underwritten public offering of 10 million shares of its common stock through a registration statement filed with the Securities and Exchange Commission. The firm will grant the underwriters a 30-day option to purchase an additional 1.5 million shares to cover over-allotments, if there are any. All of the shares in the offering are to be sold by the company.
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