FDA Policy/General

Since Our Last Issue

ANI Pharmaceuticals has signed definitive agreements to acquire a portfolio of generic products and other assets from Amneal Pharmaceuticals and Impax Laboratories. The transaction is the result of a divestiture process mandated by the Federal Trade Commission in connection with Amneal Pharmaceutical’s proposed business combination with Impax Laboratories. The parties expect to close the transaction in early May.

Otsuka Pharmaceutical Co. has agreed to acqure Neurovance, a privately held, venture-funded, clinical stage pharmaceutical company focused on attention-deficit hyperactivity disorder and related disorders.

United Therapeutics Corp. and SteadyMed have signed a definitive merger agreement under which United Therapeutics will acquire SteadyMed for $216 million. SteadyMed is a specialty pharmaceutical company focused on the development and commercialization of drug product candidates to treat orphan and high-value diseases with unmet parenteral delivery needs. SteadyMed's product portfolio includes Trevyent, a drug-device combination product that combines SteadyMed's two day, single use, disposable PatchPump technology with treprostinil, a vasodilatory prostacyclin analog, for the subcutaneous treatment of pulmonary arterial hypertension.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome