Friday, 21 February 2020

Generics News

  • Why Mylan sued US FDA over Diovan generic?

    Generics |  News | By BioSpectrum Bureau  | 0 Comment | 04 Oct, 2012

    Multinational pharmaceutical company Mylan sued the US Food and Drug Administration (FDA) for approval to sell a generic version of Novartis' blockbuster anti-hypertensive drug Diovan (vals...Read more

  • Ranbaxy now recalls 64,000 bottles of generic heart drug

    Generics |  News | By BioSpectrum Bureau  | 0 Comment | 11 Mar, 2014

    Singapore: Ranbaxy Laboratories, which is already reeling under several regulatory rebukes owing to quality apprehensions, recalled more than 64,000 bottles containing tablets of atorvastat...Read more

  • APAC Epilepsy Therapeutics market to touch $1.5 bn by 2019

    Generics |  Analysis | By BioSpectrum Bureau  | 0 Comment | 28 Feb, 2014

    Singapore: The epilepsy therapeutics market value in the Asia-Pacific (APAC) region, Australia, China, India and Japan, is expected to increase moderately, climbing from USD1.1 billion in 2...Read more

  • Pfizer, Mylan settle litigation over Detrol LA generic

    Generics |  News | By BioSpectrum Bureau  | 0 Comment | 10 Sep, 2012

    Singapore: Pfizer has settled its litigation against Mylan and Mylan Pharmaceuticals relating to Pfizer's patents covering Detrol LA (tolterodine tartrate) extended-release capsules. The p...Read more

  • Mundipharma, Horizon subsidiary sign arthritis deal

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

    Singapore: Mundipharma has signed an exclusive agreement with the Swiss subsidiary of Horizon Pharma for the commercialization and distribution of Lodotra in the Middle East and African reg...Read more

  • Aurobindo diabetes generic gets US FDA nod

    Generics |  Regulatory | By BioSpectrum Bureau  | 0 Comment | 04 Feb, 2014

    Singapore: Aurobindo Pharma has received US FDA approval for Repaglinide tablets, the generic equivalent of Novo Nordisk's Prandin Tablets. The drug is indicated as an adjunct to diet and...Read more

  • Patents worth $60 billion set to expire by 2019

    Generics |  News | By BioSpectrum Bureau  | 0 Comment | 07 Mar, 2012

    The year 2012 has brought a world of opportunities for Indian biotech companies, with big-wig biotech firms in the West facing a spree of patent expiration of their blockbuster products. Gr...Read more

  • Cipla nurtures global vision for affordable drugs

    Generics |  Analysis | By BioSpectrum Bureau  | 0 Comment | 13 Jun, 2012

    The king of generics, Cipla, has been aggressive in expanding product portfolio and reaching out to international market. Without missing any opportunity to serve the healthcare industry in...Read more

  • Gilead allows sublicense of HIV drug to generic firms

    Generics |  News | By BioSpectrum Bureau  | 0 Comment | 25 Jul, 2014

    Singapore: HIV drug developer, Gilead Sciences has partnered with Medicines Patent Pool (MPP) to expand access to Gilead's investigational drug tenofovir alafenamide (TAF) for HIV and hepat...Read more

  • Bayer plea for stay on compulsory license dismissed

    Generics |  News | By BioSpectrum Bureau  | 0 Comment | 17 Sep, 2012

    Bangalore: The Intellectual Property Appellate Board in Chennai, India, has rejected pharma major Bayer's petition seeking a stay on compulsory license to Hyderabad-based Natco Pharma for s...Read more

  • Perrigo rejects Mylan's acquisition bid

    Generics |  News | By BioSpectrum Bureau  | 0 Comment | 28 Apr, 2015

    Singapore: Irish firm, Perrigo, has declined the acquisition offer from Mylan revalued at USD60 per share in cash and 2.2 Mylan ordinary shares for each ordinary Perrigo share. The Board p...Read more

  • Ranbaxy, Lundbeck face EU fury for blocking generics

    Generics |  News | By BioSpectrum Bureau  | 0 Comment | 04 Jun, 2013

    Singapore: The European Commission (EC) is going to fine seven generic drug firms, including India-based Ranbaxy and Denmark-based Lundbeck, for limiting the supply of cheaper medicines to ...Read more

  • FDA flags GMP issues at Impax's Taiwan facility

    Generics |  News | By BioSpectrum Bureau  | 0 Comment | 31 Jul, 2014

    Singapore: Regulatory hurdles continue to haunt Impax Laboratories and its experimental drug, Rytary, that treats idiopathic Parkinson's disease. After facing a tough time with the FDA at t...Read more

  • Lupin gets FDA nod to make generic insomnia drug

    Generics |  News | By BioSpectrum Bureau  | 0 Comment | 20 Sep, 2013

    Singapore: The US FDA provided its final approval to Indian drug maker Lupin to manufacture and market a generic version of Sanofi Aventis' Ambien CR extended release tablets. Zolpidem Tar...Read more

  • Aurobindo Pharma files ANDA for HIV generic drug

    Generics |  News | By BioSpectrum Bureau  | 0 Comment | 27 May, 2015

    Singapore: India's Aurobindo Pharma has submitted an Abbreviated New Drug Application (ANDA) for dolutegravir 50mg, for tentative approval to the Food and Drug Administration (FDA), for the...Read more

  • Canadian generic maker enters Korea with JV

    Generics |  News | By BioSpectrum Bureau  | 0 Comment | 03 Jan, 2013

    Singapore: Montreal-based generic drug developer and marketer Pharmascience is venturing into Korea by forming a joint venture (JV) with Seoul-based Korea Kolmar Holdings. Pharmascience pla...Read more

  • Orexigen, Takeda file lawsuit against Actavis for patent infringement

    Generics |  Regulatory | By BioSpectrum Bureau  | 0 Comment | 08 Jun, 2015

    Singapore: Orexigen Therapeutics and Takeda Pharmaceuticals have filed a lawsuit in US against Actavis for filing an abbreviated new drug application (ANDA) to market and sell generic versi...Read more

  • FDA warns Tianjin Zhongan for cGMP lapses

    Generics |  Regulatory | By BioSpectrum Bureau  | 0 Comment | 26 Jun, 2014

    Singapore: The US Food and Drug Administration (FDA) has slapped a warning letter to China based Tianjin Zhongan Pharmaceutical company for manufacturing adulterated active pharmaceutical ...Read more