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Sun's generic of Takeda ulcer drug gets FDA nod

16 September 2013 | Regulatory | By BioSpectrum Bureau

The US Food and Drug Administration provided its approval for Lansoprazole Delayed-Release Capsules USP, 15 and 30 mg, which are therapeutic equivalents of Takeda Pharmaceutical's capsules

The US Food and Drug Administration provided its approval for Lansoprazole Delayed-Release Capsules USP, 15 and 30 mg, which are therapeutic equivalents of Takeda Pharmaceutical's capsules

Singapore: Indian pharmaceutical major, Sun Pharmaceutical Industries announced that the generic version of Prevacid by the company has received that final approval from the US FDA.

The American drug regulator provided its approval for Lansoprazole delayed-release capsules USP, 15 and 30 mg, which are therapeutic equivalents of Takeda Pharmaceutical's capsules, the company said in a press statement.

It added that these capsules, which have reported annual sales of $430 million in the US alone, are used for short-term treatment for healing and symptom relief of active duodenal ulcer.

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