Mylan Pharmaceuticals, a subsidiary of global pharmaceutical company Mylan, has launched Fenofibrate Capsules USP, 43 mg and 130 mg. Fenofibrate Capsules, which are generic equivalent to Lupin Atlantis Holdings' Antara Capsules, are ...
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Lupin Pharmaceuticals has obtained FDA approval for Suprax (Cefixime) for oral suspension, 500 mg/5mL and anticipates initiating product shipment shortly. Suprax oral suspension is indicated for otitis media, acute exacerbation of chronic ...
Tags: Lupin Pharmaceuticals, FDA, Suprax
Galderma Laboratories has gained US marketing rights for its Epiduo (adapalene 0.1%/BPO 2.5%) Gel, designed for the treatment of acne in children as young as nine years old, following the approval from the US Food and Drug Administration ...
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Dallen Medical's Compressyn Staple, designed for use in rigid small bone fixation, specifically in foot, ankle, and hand applications. Using the company's patented ...
Specialty biopharmaceutical company Santarus has announced the commercial launch of ulcerative colitis therapy, Uceris (budesonide) extended release tablets. Uceris that contains a locally acting glucocorticosteroid, budesonide, in a ...
Tags: Santarus, Uceris, ulcerative colitis therapy
The US Food and Drug Administration (FDA) has approved a new drug named Pomalyst (pomalidomide) for patients who received and did not respond to prior cancer therapies. Pomalyst, the third drug in a class of immunomodulatory agents ...
US-based Modern Plastics has announced that a spinal implant device using Evonik's VESTAKEEP PEEK (polyetheretherketone) has obtained 510(k) clearance from the US Food and Drug Administration (FDA). The implant device, which exhibits ...
Tags: Modern Plastics, Evonik, VESTAKEEP PEEK, FDA
US-based Smiths Medical has gained US marketing rights for its CADD-Solis variable infusion profile (VIP) ambulatory infusion system, following the US Food and Drug Administration (FDA) approval. The multi-therapy infusion system, which ...
Tags: FDA, therapy infusion system, Medical
Almac has cleared the FDA inspection and begun US commercial packaging operations in Audubon, Pennsylvania. The FDA concluded that the site is compliant with good manufacturing practices, with no 483 issued. Almac quality vice president ...
US-based biopharmaceutical company Hyperion Therapeutics has announced that it has gained approval from US Food and Drug Administration (FDA) for its RAVICTI (glycerol phenylbutyrate) liquid drug. RAVICTI used for treating Urea Cycle ...
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The sharemarket broke a 10-day winning streak yesterday after the US Federal Reserve said the country's economy had paused recently. However, the Australian bond market found support after a wave of selling. "Being the last day of the ...
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Genzyme and Isis have announced the FDA approval of Kynamro (mipomersen sodium) injection indicated for homozygous familial hypercholesterolemia (HoFH). The regulatory agency approved Kynamro 200mg subcutaneous injection per week as an ...
Takeda Pharmaceutical has received FDA approval for three new type 2 diabetes therapies Nesina (alogliptin) and fixed-dose combinations Oseni (alogliptin and pioglitazone) and Kazano (alogliptin and metformin HCl). Takeda expects to ...
Tags: FDA, diabetes therapies, Pharmaceuticals
Dr. Reddy's Laboratories has received the FDA approval and introduced Desloratadine orally disintegrating tablets (ODT) in 2.5mg and 5mg strengths in the US. Desloratadine ODT is a generic equivalent to Clarinex Reditabs (desloratadine), ...
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Merck has received FDA approval for an over-the-counter (OTC) treatment for overactive bladder (OAB) in women, Oxytrol for women. Various studies demonstrated a woman's ability to recognize OAB symptoms, understand vital safety ...
Tags: bladder OTC treatment, Merck, OAB symptoms