Generics News
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Generic Seroquel XR tablets launched by Lupin in USA
Generics | News | 0 Comment | 24 Aug, 2017
Lupin Limited has announced the launch of its Quetiapine Fumarate Extended-Release Tablets, 50 mg, 150 mg, 200 mg, 300 m...Read more
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Generics | News | 0 Comment | 21 Aug, 2017
Singapore – US FDA has granted two orphan drug designations (ODD) for T cell therapy products to Singapore-ba...Read more
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FDA provides new tools for tests to detect Zika virus infection
Generics | News | 0 Comment | 18 Aug, 2017
Singapore- As an additional measure in the fight against Zika virus, today the U.S. Food and Drug Administration announc...Read more
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Bruker announces US FDA clearance of expanded 3rd claim for MALDI Biotyper
Generics | News | 0 Comment | 01 Aug, 2017
Singapore – Bruker, a US based manufacturing company of scientific instruments announced that it has received US F...Read more
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LEO Pharma gets EC nod for its first and only biologic Kyntheum that targets the IL-17 receptor
Generics | News | 0 Comment | 26 Jul, 2017
LEO Pharma announced that the European Commission has granted marketing authorization for Kyntheum (brodalumab), a new b...Read more
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Merck wins tentative U.S. FDA approval for Lusduna
Generics | News | 0 Comment | 26 Jul, 2017
Merck announced in a press release that the U.S. Food and Drug Administration (FDA) has granted tentative appr...Read more
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Study suggests positive airway pressure therapy could reduce COPD patient hospitalizations
Generics | News | 1 Comment | 11 Jul, 2017
Singapore - COPD hospitalizations are at an all-time high. The 30-day readmission rate for patients ranges from 20-39 pe...Read more
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Japanese regulators grant additional approval for the sale of Ipsen's rare cancer drug in Japan
Generics | News | 1 Comment | 04 Jul, 2017
Bringing in much needed relief for millions of gastroenteropancreatic neuroendocrine cancer patients, the Japanese regul...Read more
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Taiwan Pharma Association opens new office in Malaysia
Generics | News | 0 Comment | 09 Jun, 2017
Singpaore: In a bid to strengthen trade between two countries, the Taiwan Pharmaceutical Manufacturer’s Associatio...Read more
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Astellas prostrate cancer drug gets EU nod
Generics | News | By BioSpectrum Bureau | 0 Comment | 25 Jun, 2013
Singapore: The European Commission has approved Xtandi (enzalutamide) capsules for the treatment of men with metastatic ...Read more
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Sanofi, Carlyle to buy Elder Pharma for $450 mn
Generics | News | By BioSpectrum Bureau | 0 Comment | 25 Jul, 2013
Singapore: Sanofi's India unit and Carlyle group are in talks to buy the domestic drug formulation business of Indian dr...Read more
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Gilead's cancer drug under FDA scrutiny
Generics | Regulatory | By BioSpectrum Bureau | 0 Comment | 15 Mar, 2016
Singapore: US Food and Drug Administration has raised alarm for Gilead Science's cancer medicine Zydelig (idelalisib) du...Read more
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US FDA seeks inputs on its generic drug amendments
Generics | Regulatory | By BioSpectrum Bureau | 2 Comment | 04 Sep, 2012
Singapore: On July 9, 2012, the Generic Drug User Fee Amendments of 2012 (GDUFA) was enacted by the US. The Food and Dru...Read more
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Lupin gets FDA nod for generic Ortho Tri-cyclen Lo Tablets
Generics | Regulatory | By BioSpectrum Bureau | 2 Comment | 05 Jul, 2012
Mumbai: Mumbai-based pharma major Lupin's subsidiary, Lupin Pharmaceuticals, has received approval for its Norgestimate ...Read more
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FDA approves Sun Pharma's generic Prandin
Generics | Regulatory | By BioSpectrum Bureau | 0 Comment | 12 Jul, 2013
Singapore: The US Food and Drug Administration (FDA) has given its finally approval to India's Sun Pharmaceutical Indust...Read more
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Cipla, Alembic contest Indian drug pricing in court
Generics | News | By BioSpectrum Bureau | 0 Comment | 17 Jul, 2013
Singapore: Miffed at Indian government's move to slash prices of essential medicines through the new drug pricing policy...Read more
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Indian drug dealers worried about $1.69 bn old stocks
Generics | News | By BioSpectrum Bureau | 0 Comment | 02 Aug, 2013
New Delhi: Ahead of the Drug Price Control Order (DPCO) to revise drug prices that came into effect on July 29, medicine...Read more
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First generic versions of Cymbalta receive FDA nod
Generics | Regulatory | By BioSpectrum Bureau | 2 Comment | 13 Dec, 2013
Singapore: US Food and Drug Administration has approved the first generic versions of Cymbalta (duloxetine delayed-relea...Read more
