Granules India gets USFDA nod for Loratadine tablets

The company further said that it intends to commercialise this product "shortly".

298
Medicine
Picture: Pixabay
< 1 min. read

New Delhi: Granules India on Tuesday said the US health regulator has given its approval to the abbreviated new drug Application filed by the drug firm for Loratadine tablets used to treat allergies.

“The US Food & Drug Administration (USFDA) has approved the Abbreviated New Drug Application (ANDA) filed by Granules India Ltd, for Loratadine tablets USP, 10 mg (OTC),” Granules India said in a filing to BSE.

The approved ANDA is the bioequivalent to the Reference Listed Drug (RLD), Claritin tablets 10 mg by Bayer HealthCare LLC, the filing said.

The company further said that it intends to commercialise this product “shortly”.

The shares of Granules India were trading at Rs 127.70, up 0.47 per cent on BSE in the morning trade.


Also read some previous news
Strides Pharma gets tentative nod from USFDA for pain relieving drug
Alembic gets USFDA approval for Silodosin capsules
Zydus Cadila gets USFDA nod for Isosorbide Dinitrate tablets, Desonide Cream
Unichem Labs gets USFDA nod to market anxiety disorder tablets
Novartis sickle-cell drug gets USFDA approval


LEAVE A REPLY

Please enter your comment!
Please enter your name here