Us Food And Drug Administration News
Alembic gets USFDA nod for generic ophthalmic solution
The company has received tentative approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Alcaftadine Ophthalmic Solution,
1 min read20 Apr 2020Aurobindo Pharma to recall 80 lots of blood pressure medicine Valsartan in US
The impurity N-Nitrosodiethylamine (NDEA) was detected in quantities above the acceptable limit in certain tablets containing valsartan, the FDA said.
1 min read2 Jan 2019Sun Pharma again faces FDA heat on Halol plant
US drug regulator makes six observations related to deficient procedures
2 min read7 Sep 2018Daiichi-Ranbaxy row: Delhi HC restrains Singh brothers from using bank a/cs
Delhi HC also directed them to submit the gift deed of a painting worth 7.59 crore, title document of their Singapore apartment and details of any other bank a/cs, if any
3 min read10 Aug 2018Glenmark inks pact with Seqirus to commercialise Ryaltris in Australia, New Zealand
Ryaltris is indicated for treatment of symptoms associated with seasonal allergic rhinitis (SAR) in patients over 12 years of age
1 min read6 Jul 2018Lupin launches generic antibiotic inhalation solution in US
Lupin ’s Tobramycin Inhalation Solution USP, 300 mg/5 ml, is the generic version of Novartis Pharmaceuticals Corporation’s Tobi 300 mg/5 ml
1 min read13 Jun 2018Issues raised by USFDA on Halol resolved: Sun Pharma
Sun Pharma says the USFDA has concluded its inspection and issues raised over the Halol plant in its letter issued in 2015 have been addressed
1 min read12 Jun 2018Sanofi set to roll out quadrivalent vaccine against influenza
The new quadrivalent flu vaccine manufactured by Sanofi provides protection against four strains of influenza virus and it will soon be launched in India
3 min read11 Jun 2018USFDA finishes inspection at Alembic Pharma’s Panelav plant, shares rise on BSE
The shares of Alembic Pharma were trading at ₹517 on the Bombay Stock Exchange (BSE), up 2.59%, from the previous close
1 min read24 Apr 2018Divi’s Labs shares close 16% higher as USFDA set to lift import alert on Vizag unit
The lifting of the import ban by USFDA on Divi’s Labs Visakhapatnam plant will pave the way for the company to fully resume exports to the US market
1 min read2 Nov 2017Popular Topics
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