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Wockhardt recalls over 1.62 lakh cartons of drugs in US

Drug firm Wockhardt is recalling 1,62,142 cartons of various drugs, which are used to treat ailments like high blood pressure…

Updated: July 17, 2015 11:32 IST

Wockhardt recalls 12 drugs in US made at two India units

Wockhardt has decided to voluntarily recall all the remaining batches of 12-15 products that were manufactured in the Chikalthana and…

May 21, 2015 07:55 IST

US FDA public meeting on June 15 on reauthorisation of GDUFA

FDA has invited public suggestions on the GDUFA programme and the features FDA should propose for the next programme

May 21, 2015 07:50 IST

US FDA nod for generics of Abilify

To market generic aripiprazole in multiple strengths and dosage forms to treat mental disorders

May 21, 2015 07:40 IST

Merck receives FDA Fast Track Designation for Evofosfamide

It will help in treating patients living with advanced pancreatic cancer

May 13, 2015 13:11 IST

DRL, Promius Pharma files NDAs with US FDA

Dr Reddy’s Laboratories and its subsidiary, Promius Pharma announced the filing of three 505(b)(2) New Drug Applications (NDAs) with the…

April 21, 2015 16:05 IST

DRL and its subsidiary Promius Pharma files three NDAs with US FDA

The three NDAs – DFD-01, DFD-09, and DFN-11, are in support of Dr Reddy’s Proprietary Products group

Updated: April 8, 2015 15:02 IST

US FDA, DCG(I) explore more ways to work together

Willing to collaborate with Indian regulators, other stakeholders: US FDA

Updated: March 19, 2015 15:28 IST

US FDA approves new antibacterial drug Avycaz

The most common side effects include vomiting, nausea, constipation and anxiety

February 26, 2015 15:51 IST

US FDA raises concerns over Lupin’s plant at Pithampur

FDA inspected the plant in January this year and listed six observations on the manufacturing processes at the plant

February 24, 2015 15:44 IST

Novartis Cosentyx’s first IL-17 inhibitor to receive EU approval

Cosentyx is the only biologic that can be used as first-line systemic therapy in the treatment of psoriasis and as…

January 19, 2015 17:27 IST

Jubilant Life Sciences, Lupin and Aurobindo Pharma receives US FDA approval for Valsartan tabs

Jubilant Life Sciences, Lupin and Aurobindo Pharma have received final approval from the US Food and Drug Administration (US FDA)…

Updated: January 6, 2015 18:40 IST

Jubilant Life Sciences receives US FDA nod for Mycophenolate and MofetilRizatriptan tablets

Mycophenolate Mofetil is an immunosuppressant to help prevent organ rejection in transplants and Rizatriptan is used for the treatment of…

January 6, 2015 12:14 IST

Drug firms face ANDA blues

The delay in approval of generic drug applications, which has been slowly declining annually, witnessed its lowest run-rate in the…

Updated: December 15, 2014 05:52 IST

US FDA approves Gardasil 9 for prevention of certain cancers caused by five additional types of HPV

Gardasil 9 has the potential to prevent approximately 90 per cent of cervical, vulvar, vaginal and anal cancers

December 11, 2014 10:10 IST

Germany bars Ranbaxy’s antibiotic drug from Dewas plant

The regulator found deficiencies related to operation of drug manufacturing rooms and procedures related to sterilisation of equipment at the…

Updated: December 4, 2014 18:10 IST

Dr Reddy’s unit receives US FDA observations on possible lapses

The US Food and Drug Administration (US FDA) has found what it calls nine “inspectional observations” at Unit VI of…

Updated: November 27, 2014 15:56 IST

Dr Reddy’s unit receives USFDA observations on possible lapses

The US Food and Drug Administration (USFDA) has found what it calls nine “inspectional observations” at Unit VI of Dr…

November 27, 2014 00:37 IST

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