Drugs

Reject Mayne Pharma Doryx MPC Petition: Mylan

Mylan says that a Mayne Pharma petition asking the agency to refuse to receive and not approve any ANDA referencing its Doryx MPC (doxycycline hyclate delayed-release tablets) unless specific in vitro dissolution criteria are met “appears to be nothing more than a veiled attempt to delay generic competition by asking FDA to impose additional requirements that require ANDA products to embody dissolution profiles that Mayne Pharma may claim are covered by its patents.” The petition asks FDA to deny the Mayne Pharma filing in its entirety.

According to Mylan, Mayne claims that the Doryx MPC formulation offers a clinical advantage over other doxycycline hyclate delayed-release tablets by producing fewer gastrointestinal adverse reactions. Mylan argues that Mayne has not produced any clinical data demonstrating a reduction in gastrointestinal adverse reactions for its product compared to others. “Although Doryx MPC may have been designed to minimize gastrointestinal adverse reactions,” Mylan says, “the approved labeling for Doryx MPC does not support a claim of clinical advantage over Doryx delayed-release tablets. In fact, the approved labeling for Doryx MPC is identical to the approved labeling for Doryx DR tablets with respect to gastrointestinal adverse reactions.”

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