Formulary Digital Edition November 2010

FDA Sets Review Date for Zoryve in Atopic Dermatitis

Adzynma is a recombinant protein designed to replace the deficient ADAMTS13 enzyme to treat patients with the rare hereditary blood clotting disorder congenital thrombotic thrombocytopenic purpura

FDA Issues Warning about Seizure Medications

The FDA has set a date of July 07, 2024, for Zorvye 0.15% for adults and children six and up with the chronic skin disease atopic dermatitis.

FDA Issues Complete Response for Novel Dry Eye Therapy

Regulators have found that medications containing levetiracetam and clobazam have led to drug reaction with eosinophilia and systemic symptoms (DRESS), a rare and severe drug allergy.

FDA Sets Review for Nasal Opioid Rescue Drug

Regulators indicated that an additional trial would be needed to assess the efficacy of reproxalap to treat patients with dry eye. Aldeyra has submitted to the FDA a Special Protocol Assessment for the new trial.

FDA Approves First Treatment for Rare Noncancerous Tumors

The product, OX124, uses a powder-based technology that provides rapid absorption of naloxone for patients experiencing an opioid overdose. The FDA review date is July 15, 2024.

Photo courtesy of SpringWorks Therapeutics

Enzyme Replacement Therapy Adzynma Launches with $245,000 Annual Price

Ogsiveo will be available within five to 10 business days to treat patients with desmoid tumors. It will launch with a price of $29,000 for a 30-day supply.

Related Content

FDA Sets Review Date for Zoryve in Atopic Dermatitis

Adzynma is a recombinant protein designed to replace the deficient ADAMTS13 enzyme to treat patients with the rare hereditary blood clotting disorder congenital thrombotic thrombocytopenic purpura

FDA Issues Warning about Seizure Medications

The FDA has set a date of July 07, 2024, for Zorvye 0.15% for adults and children six and up with the chronic skin disease atopic dermatitis.

FDA Issues Complete Response for Novel Dry Eye Therapy

Regulators have found that medications containing levetiracetam and clobazam have led to drug reaction with eosinophilia and systemic symptoms (DRESS), a rare and severe drug allergy.

FDA Sets Review for Nasal Opioid Rescue Drug

FDA Approves First Treatment for Rare Noncancerous Tumors

The product, OX124, uses a powder-based technology that provides rapid absorption of naloxone for patients experiencing an opioid overdose. The FDA review date is July 15, 2024.