Drugs

Teva Sues FDA Over Generic Restasis Exclusivity

Teva has filed suit in D.C. federal court claiming that an FDA interpretation of the definition of “first applicant” for a generic form of Restasis (cyclosporine) is unlawful. Attorney Kurt Karst (Hymen, Phelps & McNamara) writes in his firm’s FDA Law Blog that a new FDA position was seen in a 7/13 letter decision explaining the agency’s rationale for determining that eligibility for 180-day exclusivity for certain strengths of generic Suboxone (buprenorphine and naloxone) sublingual film was forfeited. In that letter, the agency adopted a “First Submitted Interpretation Approach.”

“Until now,” Teva says in its suit, “FDA consistently maintained that eligibility for 180-day exclusivity hinges on a generic applicant submitting a legally valid challenge to the innovator’s patents that complies with all statutory requirements for such challenges, including the requirement to notify the brand manufacturer of any such challenge so that it can evaluate whether to sue the generic applicant for patent infringement.” The company says the agency’s attempt to jettison a 2016 rule that upheld its longstanding position in the context of a quasi-adjudicatory proceeding is thus “as procedurally defective as it is substantively baffling.”

The company asks the court for declaratory and injunctive relief, including a declaration that FDA’s Suboxone letter decision “was issued without observance of procedure required by law and otherwise is arbitrary, capricious, an abuse of discretion, and not in accordance with law.” It also wants a court declaration that Teva’s ANDA for generic Restasis is entitled to 180-day exclusivity, and an order enjoining the agency from approving any ANDA for Restasis that “was not substantially complete as of 1/14/14 and/or for which the ANDA’s sponsor did not submit a lawfully maintained Paragraph 4 certification on 1/14/14.”

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