Generics
Ranbaxy may settle with FDA for generic atorvastatin launch
According to The Times of India, generics giant Ranbaxy Laboratories and FDA are getting closer to reaching an agreement to solve the Indian drugmaker’s regulatory troubles.
Quality by design for generics by 2013
Quality by design (QbD) is already being implemented by FDA for new drug applications, but now, in an attempt to prepare generics manufacturers for QbD in 2013, FDA is preparing to publish immediate and modified release QbD examples.
The pharmaceutical market in Brazil
The Brazilian pharmaceutical market is the third largest in the Americas region, after Canada and USA, it ranks first in the Latin American region. Pharmaceutical demand will continue to rise, fuelled by increasing disposable income, therefore, the market outlook is positive for the 2011–2016 period.
Advocates demand generic version of Abbott’s HIV drug Kaletra
FDA watchdog Public Citizen, along with public health groups in a dozen countries, has launched a global campaign demanding the authorisation of generics competition for Abbott Laboratories’ HIV drug Kaletra (lopinavir/ritonavir) before its exclusivity expires.
Ranbaxy gets FDA approval and launches generic atorvastatin
After all the speculation India-based Ranbaxy Laboratories (Ranbaxy) has resolved all outstanding issues and finally managed to gain approval from FDA for its generic version of the blockbuster cholesterol-reducing drug Lipitor (atorvastatin).
Strides Arcolab gains FDA approval for two cancer generics
India-based generics manufacturer Strides Arcolab announced on 24 November 2011 that its wholly-owned subsidiary, Onco Therapies, had gained FDA approval for generic versions of cancer treatments carboplatin and oxaliplatin.
Mylan poised to enter generic inhalers market
The global market for respiratory asthma and chronic obstructive pulmonary disorder (COPD) inhalers, a specialist field, is valued at more than US$34 billion (Euros 25.1 billion) and is averaging 7% growth per year according to IMS Health. More than 50% of this market is expected to lose patent protection by the end of 2016, including several blockbuster products, many of which are inhaler based.
Actavis launches generic valsartan in Europe
On 18 November 2011, Iceland-based generics company Actavis announced the launch of generic valsartan and valsartan HCT in nine European countries.
Generic atorvastatin partnership
In early November 2011, there has been speculation that Ranbaxy Laboratories and Teva are about to join in manufacturing generic atorvastatin, better known as Lipitor, in the US.
Stada to buy Spirig’s generics business
German generics giant Stada Arzneimittel announced on 9 November 2011 that it had signed a deal to buy Switzerland-based Spirig Pharma’s generics business for approximately Euros 78 million.
