Drugs

Alvogen Suing FDA Over Generic Belbuca Exclusivity

Alvogen has filed suit in DC federal court asking it to order FDA to approve the firm’s ANDA for buprenorphine film in several strengths and to determine that Teva has forfeited any entitlement to 180-day marketing exclusivity for its buprenorphine film ANDAs. The suit says Alvogen submitted its ANDA for a generic form of BioDelivery Sciences’ Belbuca (buprenorphine film) 5/23/18 and received tentative FDA approval 6/12/19. At the time, Alvogen says, the agency said it delayed final approval of the ANDA because of a 30-month stay on the company’s ANDA in place at that time.

“In anticipation of the 30-month stay’s expiration, Alvogen requested final approval of its ANDA on 1/30,” the suit says. “Alvogen expected to receive final approval because publicly available information indicated that Teva Pharmaceuticals, the first applicant to submit purportedly substantially complete ANDAs for buprenorphine buccal film and containing a Paragraph 4 certification must have forfeited exclusivity.”

However, the suit says, FDA sent another tentative approval letter 2/4 citing “exclusivity issues” as a reason for maintaining tentative approval. “According to FDA,” the suit says, “Alvogen’s ANDA is not eligible to receive final approval until the date that is 180 days after Teva begins commercial marketing of its ANDA product.”

Alvogen maintains that Teva forfeited its right to 180 days of exclusivity for at least two reasons — failing to obtain approval of its ANDAs within 30 months of submission and failing to maintain its Paragraph 4 certification.

The company says FDA is denying it the opportunity to gain significant customers that otherwise would be available to it and also says it has made a significant investment in its generic product on the expectation that it would receive final approval 1/30.

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

Read more

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