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The FDA’s Division of Drug, Marketing, Advertising and Communication (DDMAC) has issued a warning letter to Janssen Pharmaceutica regarding a “Dear Healthcare Provider” (DHP) letter that included misleading claims about the company’s atypical antipsychotic drug Risperdal.
The FDA yesterday said it was requiring the addition of new risk information to the health professional labeling for Zelnorm (tegaserod maleate), the only agency-approved drug for the short-term treatment of women with irritable bowel syndrome.
Manufacturers of all exocrine pancreatic insufficiency drug products (PIDs) will have to submit new drug applications (NDAs) to the FDA and have them approved within the next four years to remain on the market.
The FDA has not received a single polymorph patent for filing in the Orange Book since new drug patent rules went into effect last year, according to FDA officials, who are seeking input on implementing the changes to the Hatch-Waxman Act patent law.
The biotechnology industry is looking for a great deal more FDA guidance on how to navigate the drug approval process for biological products, according to an industry attorney.
Legal experts speaking at a recent industry conference warned drugmakers not to “get ahead of the FDA” in making safety and efficacy claims about pipeline products in light of recent changes in the way the agency and the Securities and Exchange Commission (SEC) share confidential information about drug approval procedures.
Alphapharm has filed an application with the FDA challenging patents on Forest Laboratories’ antidepressant Lexapro (escitalopram oxalate), according to Forest.