Glenmark Pharmaceutical Ltd said its unit received abbreviated new drug application (ANDA) approval from the US Food and Drug Administration (USFDA) to introduce Theophylline extended-release tablets in the US market.
Theophylline extended-release tablets, used in treatment of chronic asthma and other chronic lung diseases, are the generic version of LP Uniphyl of Purdue Pharmaceutical Products. Glenmark’s extended-release tablets are available in strengths of 400 mg and 600 mg. The company will commence marketing and distribution of this product in the US.
According to IMS Health, Theophylline extended-release tablets had annual sales of $8 million.
On Wednesday, Glenmark shares closed 0.6% up at Rs279 on the Bombay Stock Exchange, while the Sensex ended at 0.3% down at 17,938 points.
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