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The FDA late Friday approved Cubist Pharmaceuticals’ antibiotic Sivextro, the second drug approved for acute bacterial skin and skin structure infections as part of the agency’s effort to encourage the development of new antibiotics as a bulwark against growing drug resistance. Read More
Akorn Enterprises, or its new subsidiary Hi-Tech Pharmacal, was required to sell the marketing rights for five generic drugs to Watson Laboratories to settle federal charges that Akorn’s acquisition of Hi-Tech was anticompetitive, the FTC said. Read More
Pfizer-subsidiary Wyeth is claiming immunity in a long-running antitrust lawsuit involving an alleged pay-for-delay generics scheme with Teva, but a group of pharmaceutical purchasers aren’t buying the argument. Read More
The FDA has slapped two generic manufacturers with separate warning letters for not paying registration fees on their facilities under GDUFA. Read More
The FTC gave generics makers a boost last week in their fight to stop brand drugmakers from using REMS restrictions to block access to sample drugs the generics industry needs to prepare ANDAs. Read More
Australian pharmaceutical regulators have finalized an extensive list of drug products and risk statements that manufacturers of nonprescription drugs should use when changing their labels to meet a requirement that goes into effect at the end of next year. Read More
Federal and state lawmakers are questioning whether the FDA’s Expanded Access program, which allows terminally ill patients to use experimental drugs in certain cases, adequately addresses the current need, with several states considering legislation that would let patients bypass the agency in acquiring investigational therapies. Read More
SAN DIEGO — Two years after it was launched, the FDA’s breakthrough therapy designation, and what qualifies as a breakthrough, continues to baffle drugmakers who have experienced a roughly 63 percent rejection rate in receiving the expedited designation. Read More
Each year, up to 20 percent of the U.S. population gets the flu, resulting in more than 200,000 flu-related hospitalizations and 36,000 deaths. Read More