New Delhi: Macleods Pharma USA Inc is recalling 31,968 bottles of Pioglitazone Hydrochloride tablets used for treatment of diabetes in the American market. The tablets being recalled are in the strength of 15 mg and have been manufactured by Macleods Pharmaceuticals Ltd in its Baddi facility in Himachal Pradesh, an enforcement report of the USFDA said.
Enforcement Report - Week of October 23, 2019
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Anvisa suspends batch 822,182 of the generic drug Pioglitazone Hydrochloride on Monday (31/10). The company EMS S / A that makes oral antidiabetic used for glycemic control informed the Agency about a possible error in the description of the dosage of the medicine packaging.
The diabetes drug Actos (pioglitazone), once under intense scrutiny for possible risks to the heart, now has study data showing a cardiovascular benefit. In patients who'd recently suffered a stroke, the Takeda drug beat placebo at holding off additional strokes and heart attacks.
Japan promises an exciting regulatory ride in 2016 as the Sakigake fast-approval process plays out, with 6 candidates already in a pilot, while R&D funds get added to the country's budget. However, price cuts loom for best-selling drugs along with an every-other-year reimbursement level review for all drugs due in April.
The R&D collaboration efforts keeping coming from Osaka-based Takeda Pharmaceutical with a push now on Parkinson's disease with NsGene looking at a regenerative therapy involving a biotherapeutic brain implant.
Macleods` Generic Pioglitazone HCL & Metformin HCL approved in US for diabetes