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Last Updated : Mar 23, 2017 04:31 PM IST | Source: Moneycontrol.com

Lupin gets US FDA nod for generic antibiotic inhalation drug

Tobramycin inhalation had US sales of USD 133.6 million as on December 2016 according to IMS data.

Drug maker Lupin on Thursday said it has received final approval from US FDA for its generic antibiotic inhalation drug.

The drug in question -- Tobramycin inhalation solution USP, 300 mg/5 ml  -- is a generic version of Swiss pharmaceutical company Novartis's Tobi.

Tobramycin is a type of inhaled antibiotic prescribed for people with a genetic disorder, who develop lung infection.

Tobramycin inhalation had US sales of USD 133.6 million as on December 2016 according to IMS data.

Lupin said tobramycin is the first generic approval in the inhalation space.

Lupin has the 5th largest pipeline of ANDA filings pending approval with the US FDA – 134 product filings pending approval. Cumulative filings with the US FDA now stand at 347 with the company having received approvals for 213 products.

Lupin has been working on complex generics with innovated drug delivery mechanisms such as inhalers, patches and films. It faces competition from me-too generic players.

Shares of Lupin rose 1.58 percent to close at Rs 1490 on BSE, the benchmark Sensex gained 0.56 percent to end at 29,332.16 points.
First Published on Mar 23, 2017 04:31 pm
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