Enforcement Report - Week of February 7, 2024
Azurity Pharmaceuticals is recalling one batch of Zenzedi 30mg tablets from U.S. shelves after it received a report from a pharmacist in Nebraska who opened a bottle of the narcolepsy treatment and instead found carbinoxamine maleate, an antihistamine drug.
Azurity Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Zenzedi® (dextroamphetamine sulfate tablets, USP) 30 mg Due to a Mislabeled Package During Manufacturing
As the nationwide shortage of Adderall and other meds for attention-deficit/hyperactivity disorder (ADHD) drags on, several members of Congress are pushing for more transparency and urgency from regulators on their mitigation efforts.
Glenmark Pharmaceuticals on Thursday said it has entered into an exclusive agreement with Cediprof Inc for supply and distribution in the US for the latter's generic drug indicated for the treatment of attention deficit hyperactivity disorder.
Hyderabad (Telangana): Granules India announced on Tuesday that the US Food and Drug Administration (US FDA) has approved the abbreviated new drug application (ANDA) filed by its US subsidiary -- Granules Pharmaceuticals, Inc (GPI) -- for Amphetamine mixed salts used for treating attention disorder.
MIAMI and JERSEY CITY, N.J., Jan. 10, 2023 /PRNewswire/ -- Noven Pharmaceuticals. Inc., (Noven), a wholly owned subsidiary of Hisamitsu Pharmaceutical Co., Inc. focusing on the development of transdermal treatments, announced today that XELSTRYM™ (dextroamphetamine) transdermal system, CII, the first and only FDA-approved amphetamine patch for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in adults and pediatric patients six years and older, will be available across the U.S. for healthcare professionals to prescribe later in the first quarter of 2023.1 In anticipation of this, Noven will be publicly presenting XELSTRYM in a branded capacity for the first time at the American Professional Society of ADHD and Related Disorders (APSARD) Conference being held January 13-15 in Orlando, Florida.
It is no secret that drug shortages have been prevalent in 2022. Several major drug products, such as amoxicillin and Adderall, have been in short supply for several months and have led to members of Congress applying pressure on the FDA and HHS to resolve the situation.
MONMOUTH JUNCTION, N.J., Oct. 19, 2022 /PRNewswire/ -- Tris Pharma, Inc. (Tris) a fully integrated pharmaceutical company with a robust portfolio of CNS products announced today that DYANAVEL® XR (amphetamine) extended-release tablets, for oral use, CII and DYANAVEL® XR (amphetamine) extended-release oral suspension, CII are stocked by wholesalers and continue to be available in pharmacies. DYANAVEL XR was approved by the U.S. Food and Drug Administration for the treatment of Attention- Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older. Dyanavel XR may be an option for health care providers and patients who can no longer fill their prescription of Adderall due to a stocking shortage.
Enforcement Report - Week of September 21, 2022