Indian firm gets FDA approval for new Lupin pain relief

The US subsidiary of Indian pharmaceutical company Lupin has been given final approval from the US health regulator for its Hydrocodone Bitartrate and Acetaminophen tablets.

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Hitting the market

Lupin Somerset, also known as Novel Laboratories Inc, can now market the tablets in 5mg/325mg, 7.5mg/325mg and 10mg/325mg strengths. Designed to be used for moderate to moderately severe pain relief, they are a generic version of Allergan Sales LLC’s Norco tablets in the same strengths.

The transnational company, which is the fifth largest pharmaceutical firm in the US by prescriptions, has said its US arm, Gavis Pharmaceuticals LLC, will launch the product shortly. In its filing to the Bombay Stock Exchange, Mumbai-based Lupin said the Hydrocodone Bitartrate and Acetaminophen Tablets USP had sales of $89.6m in the US, according to IMS MAT September 2016.

Premarket notification

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The FDA requires manufacturers to notify it of their intent to market at least 90 days in advance.
Each year, its Centre for Drug Evaluation and Research (CDER) approves a range of new drugs, providing advice to ensure they are safe, high-quality and effective generic alternatives. All FDA-approved generic drugs have the same quality, strength, purity and stability as brand-name tablets and must pass the same quality standards in packaging, manufacturing and testing.

Lupin has the fifth largest amount of abbreviated new drug applications pending FDA approval, which now stands at 339. It has already received approvals for 198 of its products. Now that Lupin has gained final approval, the tablets, which are suitable for patients who need moderate to moderately severe pain relief, will soon be available for purchase in the United States.

Lupin was established in 1967 and employs more than 1,000 people in the manufacturing of pain relief pharmaceuticals, healthcare products and herbal products. It also makes food supplements and personal care products. After it was given the FDA nod for the new analgesic drugs, the firm’s shares went up 1.24 per cent. It recently posted a net profit of 6,530.8m rupees for the quarter ending September 2016.

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