Upsher-Smith Laboratories on Wednesday announced that it has received final approval from the Food and Drug Administration for its new drug application for Vogelxo (testosterone) gel for topical use CIII.
Teva Pharmaceutical and Labrys Biologics, a privately-held development stage biotechnology company focused on treatments for chronic migraine and episodic migraine, on Tuesday announced that Teva has entered into a definitive agreement to acquire Labrys in a deal for $200 million in upfront payment in cash at closing as well as up to $625 million in contingent payments upon achievement of certain pre-launch milestones.
Mylan announced on Monday that it has entered into a settlement and license agreement with Pfizer relating to Mylan's abbreviated new drug application filed with the U.S. Food and Drug Administration for celecoxib capsules in 50-mg, 100-mg, 200-mg and 400-mg strengths.
Teva Pharmaceutical Industries announced on Friday that the U.S. District Court for the Northern District of West Virginia has denied a motion filed by Mylan and issued an opinion and order affirming a decision by the FDA under which Teva should receive sole 180-day “first-to-file” exclusivity for generic Celebrex (celecoxib) 100-, 200- and 400-mg capsules.
The Food and Drug Administration on Thursday announced it required Sunovion Pharmaceuticals, manufacturer of the sleep drug Lunesta (eszopiclone), to change the drug label and lower the current recommended starting dose.
Pfizer announced plans to submit a new drug application with the Food and Drug Administration for palbociclib, which is used for the first-line systemic treatment of post-menopausal women with advanced or metastatic breast cancer.
Actavis on Monday announced that it has entered into an agreement with Valeant Pharmaceuticals International to settle all outstanding patent litigation related to Actavis' generic version of Acanya (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/2.5%.
Bayer HealthCare on Tuesday announced that the Food and Drug Administration's Office of Orphan Products Development has granted orphan drug designation for Bayer's investigational Ciprofloxacin Dry Powder for Inhalation (Ciprofloxacin DPI) for the treatment of non-cystic fibrosis bronchiectasis.
GlaxoSmithKline and Genmab A/S announced last week that the Food and Drug Administration has approved a supplemental biologic license application for the use of Arzerra (ofatumumab) in combination with chlorambucil for the treatment of previously untreated patients with chronic lymphocytic leukaemia for whom fludarabine-based therapy is considered inappropriate.
MannKind Corp. on Tuesday announced that the Endocrinologic and Metabolic Drugs Advisory Committee of the Food and Drug Administration voted 13-to-1 to recommend that Afrezza (insulin human [rDNA origin]) inhalation powder be granted marketing approval by the FDA to improve glycemic control in adults with Type 1 diabetes and voted 14-to-0 to recommend that Afrezza be granted marketing approval by the FDA to improve glycemic control in adults with Type 2 diabetes.
Actavis and Valeant Pharmaceuticals International announced that the Food and Drug Administration approved the new drug application for Metronidazole 1.3% vaginal gel. The antibiotic is used for the treatment of bacterial vaginosis, an infection caused by an imbalance in the normal bacteria of vagina.
Celgene on Friday announced that the Food and Drug Administration has approved Otezla (apremilast), the company's oral, selective inhibitor of phosphodiesterase 4 (PDE4), for the treatment of adult patients with active psoriatic arthritis.
Mallinckrodt Plc last week announced that the Food and Drug Administration approved Xartemis XR (oxycodone hydrochloride and acetaminophen) Extended-Release Tablets (CII), for the management of acute pain severe enough that it requires opioid treatment.
Upsher-Smith has received approval from the Food and Drug Administration for Qudexy XR (topiramate) extended-release capsules, a once-daily, broad-spectrum antiepileptic drug specifically engineered to deliver a smooth pharmacokinetic profile.