News Releases

New ADHD Rx Gets FDA Nod
Neos Therapeutics, Inc. (Nasdaq:NEOS), a pharmaceutical company with a late‐stage pipeline of innovative extended-release (XR) product candidates for the treatment of attention-deficit/hyperactivity disorder (ADHD), today announced that the U.S. Food and Drug Administration (FDA) approved Adzenys XR-ODT™ for the treatment of ADHD in patients six years and older. With this approval, Adzenys XR-ODT is the first and only extended-release orally disintegrating tablet (ODT) for the treatment of ADHD.
Children's Dosing Cups Recalled
Perrigo Company plc (NYSE: PRGO; TASE) of Dublin, Ireland, announced today that, following the recent recall of certain dosing cups by its supplier, it has initiated a voluntary product recall in the US to the retail level of 2 batches of its children's guaifenesin grape liquid (100mg/5 mL) and 3 batches of its children's guaifenesin DM cherry liquid (100mg guaifenesin and 5mg dextromethorphan HBr/ 5 ml) sold in 4 oz. bottles with dosage cup in a box under the store brand products listed below.
Multiple Sex Enhancement Products Recalled
R Thomas Marketing LLC is voluntarily recalling all lots of the following products to the consumer level:
Magnesium Sulfate for Injection Recalled
Hospira, Inc., a Pfizer company, has announced a voluntary recall of one lot of, MAGNESIUM SULFATE IN WATER FOR INJECTION (0.325 mEq Mg**/mL) 40 mg/mL 2g total, 50 mL (NDC: 0409-6729-24, Lot 53-113-JT, Expiry 1NOV2016) to the user level due to a confirmed customer report of an incorrect barcode on the primary bag labeling.
Weight Loss Product May Contain Hidden Ingredients
SmartLipo365 of Dallas, TX, is voluntarily recalling all lots of Smart Lipo (800, 900, 950 mg) capsules, to the consumer level.
Pediatric Ear Rx Gets FDA Nod
SAN DIEGO, Dec. 11, 2015 (GLOBE NEWSWIRE) -- Otonomy, Inc. (Nasdaq:OTIC), a biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the ear, today announced that the U.S. Food and Drug Administration (FDA) has approved OTIPRIO (ciprofloxacin otic suspension) for the treatment of pediatric patients with bilateral otitis media with effusion undergoing tympanostomy tube placement.
Chewable ADHD Rx Approved
Pfizer today announced that the U.S. Food and Drug Administration (FDA) has approved QuilliChew ER chewable tablets.
Bendeka Gets the Green Light
JERUSALEM & WOODCLIFF LAKE, N.J.--(BUSINESS WIRE)-- Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) and Eagle Pharmaceuticals, Inc. (Nasdaq:EGRX) today announce that the U.S. Food and Drug Administration (FDA) has approved BENDEKA™, (bendamustine hydrochloride) injection, a liquid, low-volume (50 mL) and short-time 10-minute infusion formulation of bendamustine.
Insulin Management System May Malfunction
On November 2, 2015, Insulet Corporation (Insulet or the Company) initiated a lot-specific voluntary Field Safety Notification (Notification) for 15 lots of the OmniPod (Pod) which were distributed in the U.S. and three lots which were distributed internationally.
New Indication for Pradaxa
RIDGEFIELD, Conn., November 23, 2015 – Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) approved Pradaxa® (dabigatran etexilate mesylate) for the prophylaxis of deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients who have undergone hip replacement surgery.