Sunday, 29 March 2020

Generics News

  • US FDA seeks inputs on its generic drug amendments

    Generics |  Regulatory | By BioSpectrum Bureau  | 0 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 Drug Administration (FDA) has now called for an industry meet to gather ...Read more

  • Lupin gets FDA nod for generic Ortho Tri-cyclen Lo Tablets

    Generics |  Regulatory | By BioSpectrum Bureau  | 0 Comment | 05 Jul, 2012

    Mumbai: Mumbai-based pharma major Lupin's subsidiary, Lupin Pharmaceuticals, has received approval for its Norgestimate and Ethinyl Estradiol Tablets, 0.18 mg/0.025 mg, 0.215 mg/0.025 mg, a...Read more

  • 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 Industries for releasing its diabetes generic Prandin. Making the announce...Read more

  • 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, drug makers Cipla and Alembic have now moved court. The Indian gov...Read more

  • 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 wholesalers and retailers have warned of many repercussions. The mos...Read more

  • First generic versions of Cymbalta receive FDA nod

    Generics |  Regulatory | By BioSpectrum Bureau  | 0 Comment | 13 Dec, 2013

    Singapore: US Food and Drug Administration has approved the first generic versions of Cymbalta (duloxetine delayed-release capsules), a prescription medicine used to treat depression and ot...Read more

  • Takeda close to releasing Norovirus vaccine

    Generics |  News | By BioSpectrum Bureau  | 0 Comment | 08 Jul, 2013

    Singapore: Japan's drug major Takeda Pharmaceutical has said that they are set to finish the early stage human studies on a vaccine against norovirus, by the end of this year. Takeda's vacc...Read more

  • Daiichi Sankyo's subsidiary launches four new generic drugs

    Generics |  News | By BioSpectrum Bureau  | 0 Comment | 18 Jun, 2015

    Daiichi Sankyo Company Limited has announced that on Friday, June 19, its generics subsidiary, Daiichi Sankyo Espha, will launch seven new generic drugs with four new active ingredients. T...Read more

  • US FDA extends timeline for generic drug approval

    Generics |  News | By BioSpectrum Bureau  | 0 Comment | 29 Oct, 2012

    Singapore: In a recent move, the US Food and Drug Administration (FDA) has decided to extend the timeline for granting tentative approval to generic drug applications. The timelines of appl...Read more

  • FDA approves generic versions of Plavix

    Generics |  Regulatory | By BioSpectrum Bureau  | 0 Comment | 18 May, 2012

    Singapore: The US Food and Drug Administration has approved generic versions of the blood thinning drug Plavix (clopidogrel bisulfate), which helps reduce the risk of heart attack and strok...Read more

  • FDA finds hair from human arm in Ranbaxy drugs

    Generics |  News | By BioSpectrum Bureau  | 0 Comment | 19 Sep, 2013

    Singapore: The US FDA released a set of further current good manufacturing practices (cGMP) violations that have been noticed at leading Indian drug maker Ranbaxy's Mohali unit. As per the ...Read more

  • TWi Pharma launches generic version of appetite loss drug

    Generics |  News | By BioSpectrum Bureau  | 0 Comment | 29 Jul, 2015

    Singapore: Taiwan based TWi Pharmaceuticals, has launched generic version of Par Pharmaceutical's Megace ES (megestrol acetate oral suspension) 625mg/5ml after the United States District Co...Read more

  • Trans-Pacific trade talks reach stalemate over IP rights

    Generics |  News | By BioSpectrum Bureau  | 0 Comment | 23 Jul, 2013

    Singapore: What started as an effort to lower trade barriers across 12 Pacific Rim nations, from the US and Canada to Vietnam and Chile, the Trans Pacific Partnership negotiations has broug...Read more

  • Activists challenge Gilead to give up Hep C drug patent

    Generics |  News | By BioSpectrum Bureau  | 0 Comment | 21 May, 2015

    Singapore: Initiative for Medicines, Access & Knowledge (I-MAK), a team of lawyers and scientists campaigning for global accessibility of medicines for hepatitis C and HIV patients, has...Read more

  • Teva, Sun to pay $2.15 bn to Pfizer, Takeda to settle patent suit

    Generics |  News | By BioSpectrum Bureau  | 0 Comment | 13 Jun, 2013

    Singapore: Teva Pharmaceuticals Industries, Israel, and Sun Pharmaceutical Industries, India, are going to pay a combined amount of $2.15 billion to US-based Pfizer in order to settle a pat...Read more

  • Daiichi Sankyo collaborates with Maruishi Pharmaceutical

    Generics |  News | By BioSpectrum Bureau  | 0 Comment | 23 Jun, 2015

    Japan's Daiichi Sankyo Company and Maruishi Pharmaceutical Co. Ltd have signed an agreement to collaborate on the commercialization of the general anaesthesia analgesic, generic Remifentani...Read more

  • Teva to uphold Copaxone patent until May 2015

    Generics |  News | By BioSpectrum Bureau  | 0 Comment | 31 Jul, 2013

    Singapore: Israel-based Teva Pharmaceuticals has recieved favourable response in England and Wales regarding the validity of the asserted claims of UK patent 762,888 relating to Copaxone (g...Read more

  • Pricing revision to cost Indian pharma $160 mn

    Generics |  Analysis | By BioSpectrum Bureau  | 0 Comment | 25 Jun, 2013

    Mumbai: The pharmaceutical industry will be widely impacted after India's National Pharmaceutical Pricing Authority (NPPA) notified leading drug majors about ceiling prices. This will lead ...Read more



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