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Pharmax launches HLC Baby B and HLC Baby F probiotic supplements By PBR Staff Writer
Pharmax, a business unit of Atrium Innovations, has introduced its new HLC Baby B and HLC Baby F probiotic supplements.
Production & Manufacturing > OTC > News
Biohaven enters into license deal for Catalent's Zydis ODT technology By PBR Staff Writer
Biohaven Pharmaceutical (Biohaven) has entered into an exclusive world-wide agreement with Catalent Pharma Solutions for its Zydis Orally Disintegrating Tablet (ODT) technology to be used in the development of Biohaven's lead drug development candidate, BHV-0223.
Production & Manufacturing > OTC > News Lupin agrees to buy remaining 40% stake in South Africa's Pharma Dynamics By PBR Staff Writer
Indian drug-maker Lupin has agreed to buy the remaining 40% stake in South African drug firm Pharma Dynamics (PD).
Production & Manufacturing > OTC > News
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Axxess gets FDA approval for high potency omega-3 recovery supplements
By PBR Staff Writer
Axxess Pharma, the Canadian pharmaceutical and nutritional supplements firm, has received approval from the US FDA to sell Omega-3 fish oil, muscle growth, muscle recovery supplements and turbo blend protein powders.
Production & Manufacturing > OTC > News
FDA approves Actavis' VIIBRYD 20mg/day dose for adults with MDD
By PBR Staff Writer
Irish pharmaceutical firm Actavis has received approval from the US Food and Drug Administration (FDA) for a lower therapeutic dose of VIIBRYD (vilazodone HCl) (20mg) designed to treat adults with major depressive disorder (MDD).
Production & Manufacturing > OTC > News
Afaxys launches first OTC emergency contraceptive ECONTRA EZ
By PBR Staff Writer
Afaxys Pharmaceuticals has launched its first over-the-counter (OTC) emergency contraceptive EContra EZ (Levonorgestrel 1.5mg), a single tablet taken orally and works by delaying or preventing ovulation.
Production & Manufacturing > OTC > News
Actavis introduces generic Temovate in US
By PBR Staff Writer
Irish pharmaceutical firm Actavis has launched a generic version of Fougera's Temovate (clobetasol cream 0.05%), a high-potency corticosteroid, in the US.
Production & Manufacturing > OTC > News
J&J's McNeil-PPC pays $25m over manufacturing adulterated infants’, children’s OTC medicines
By PBR Staff Writer
Johnson & Johnson's McNeil-PPC has pleaded guilty to a federal criminal charge that it sold over-the-counter (OTC) infant's and children's liquid medicine containing metal particles.
Production & Manufacturing > OTC > News
Ultra ZX Labs recalls Ultra ZX weight loss supplements
By PBR Staff Writer
The US Food and Drug Administration (FDA) has announced that UltraZx Labs is voluntarily recalling UltraZx weight loss supplements as it contained undeclared Sibutramine and phenolphthalein.
Production & Manufacturing > OTC > News
Actavis' Xydalba gets approval in Europe to treat ABSSSI
By PBR Staff Writer
Irish pharmaceutical firm Actavis has received marketing approval from the European Commission for Xydalba (dalbavancin), a once-weekly IV antibiotic, to treat acute bacterial skin and skin structure infections (ABSSSI) in adults.
Production & Manufacturing > OTC > News
Anabolic enters into distribution agreement with Emerson Ecologics
By PBR Staff Writer
Anabolic Laboratories, a manufacturer of pharmaceutical-made nutritional products for healthcare professionals, has selected Emerson Ecologics, a US-based provider of nutritional supplements, vitamins and natural health products, as its distribution partner.
Production & Manufacturing > OTC > News
Actavis and Medicines360 get FDA approval for pregnancy prevention drug Liletta
By PBR Staff Writer
Irish pharmaceutical firm Actavis and Medicines360 have received approval from the US Food and Drug Administration (FDA) for Liletta (levonorgestrel-releasing intrauterine system) 52mg for use by women to prevent pregnancy for up to three years.
Production & Manufacturing > OTC > News
Actavis seeks FDA approval to market generic ulcerative colitis drug Uceris
By PBR Staff Writer
Irish specialty pharmaceutical firm Actavis has submitted an abbreviated new drug application (ANDA) to the US Food and Drug Administration (FDA) seeking approval to market Budesonide Extended-release Tablets, 9mg.
Production & Manufacturing > OTC > News
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