US FDA grants Apotex industry-first approval, day after delivers warning letter

By Ben Hargreaves contact

- Last updated on GMT

(Image: Getty/Ojogabonitoo)
(Image: Getty/Ojogabonitoo)

Related tags: Apotex, Fda, Mhra, India

Apotex had seemed to be having a good week after it received US FDA approval for its generic product, only for it to then be on the receiving end of a warning letter the following day.

In the space of two days, the US Food and Drug Administration (FDA) showed Apotex both sides of its remit.

Speeding up generic competition

On August 8, Apotex achieved approval of its potassium chloride oral solution, marking the first time a product had made its way through the Competitive Generic Therapy designation.

The new regulatory process is part of the FDA’s push to lower the prices of generics by encouraging the introduction of competition, where previously there had been few or zero competitors.

Explaining the process, FDA commissioner Scott Gottlieb said in the press release​: “The quick implementation of this new pathway is part of our broader effort to foster generic competition and help address the high cost of drugs. So are our efforts to narrow the time it takes for generic drugs to reach the market by reducing the number of review cycles that generic applications typically undergo.”

The overall aim is to lower prices and avoid another situation, such as the daraprim affair​, where the lack of competition saw the price of a particular generic driven through the roof.

Ensuring GMP guidelines

Only the following day, the FDA announced that the company had been delivered a warning letter, based on an inspection of its Bangalore, India facility. An inspection from November 6 to 17, 2017 revealed violations of good manufacturing practice (GMP) by failing to “thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications”​.

The warning letter​ noted: “Your investigations into out-of-specification laboratory results and manufacturing deviations are insufficient and do not include scientifically-supported conclusions.”

In addition to this finding, the Agency also found that the company failed to establish appropriate in-process specification to ensure the quality of products at the plant.

The FDA concluded that the company’s responses to remedying the observed issues were inadequate.

The findings follow on from previous issues raised by the UK’s regulator​ concerning manufacturing problems at the same facility.

The plant in question does not produce the potassium chloride oral solution for which the company received approval.

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