Drugs

Rosemont Pharma Gets Complete Response on Valacyclovir

FDA has posted a 3/5 complete response letter to Rosemont Pharmaceuticals, rejecting the company’s NDA for valacyclovir. The agency cited GMP deficiencies documented in a recent manufacturing facility inspection.

According to the letter, the sponsor must submit an updated safety analysis that incorporates new clinical and nonclinical data collected since the original application was filed. The update must include detailed analyses of adverse events and patient exposure across studies. Specifically, the agency asked the company to:

Provide updated tabulations comparing new and previously submitted adverse-event data
Analyze trial discontinuations due to adverse events and identify any emerging trends
Submit case report forms and narrative summaries for deaths and serious adverse events observed during clinical trials
Include updated estimates of patient exposure across studies and a summary of worldwide safety experience with the drug

Additionally, FDA noted that the sponsor will need to resubmit the proposed proprietary name for the drug once all deficiencies outlined in the letter have been addressed.

Valacyclovir oral suspension is designed as a more convenient alternative to existing solid oral forms (tablets) for treating herpes virus infections, including cold sores, shingles, and chickenpox, particularly for patients who have difficulty swallowing.

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