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Ranbaxy is fighting to reclaim its first-filer generic exclusivity on AstraZeneca’s blockbuster heartburn drug Nexium with a lawsuit challenging the FDA’s recent decision to rescind tentative ANDA approval for the therapy over manufacturing violations. Read More
The FDA has proposed criteria for how an ANDA can receive an expedited review under the “first generic” review prioritization category, a move the agency hopes will ease industry confusion over the generic drug incentive. Read More
The FDA has approved an expanded indication for Genzyme’s leukemia drug Lemtrada to treat relapsing multiple sclerosis, 11 months after it initially turned down the company’s sBLA due to safety concerns. Read More
The FDA is fleshing out its expectations for drugmakers that want to participate in the agency’s rare pediatric disease voucher program, offering new details on requirements for seeking the designation, a five-year post approval reporting schedule and procedures for transferring the vouchers. Read More
English health authorities next month will decide whether to stop reimbursing 25 cancer drugs because they are too expensive, a decision that has riled manufacturers who believe it will restrict patient access to treatments. Read More
Genentech’s cancer drug Avastin won approval Friday to treat platinum-resistant, recurrent ovarian cancer in combination with chemotherapy, marking the eighth time the FDA has greenlighted the blockbuster product. Read More
The FDA has withdrawn approval of 13 NDAs, including for drugs to treat pain and hypothyroidism, after the manufacturers repeatedly failed to submit mandatory annual reports on the products. Read More
The FDA approved two sNDAs for Johnson & Johnson’s antipsychotic Invega Sustenna to treat patients with schizoaffective disorder, which will help the drugmaker offset lower sales of its neurological treatments due to generic competition. Read More
The FDA said two generic versions of Janssen’s attention deficit hyperactivity disorder drug Concerta may not be therapeutically equivalent to the brand, a decision that could result in the products being withdrawn. Read More