Generics/News
Mylan gains approval for generic of Valeant’s Zovirax
Generics giant Mylan announced on 3 April 2013 that its subsidiary Mylan Pharmaceuticals had received final approval from FDA for its abbreviated new drug application (ANDA) for acyclovir ointment 5%.
AstraZeneca settles rosuvastatin lawsuit
UK-based AstraZeneca announced on 25 March 2013 that it had entered into a deal concerning US patent infringement litigation against Actavis (formerly known as Watson Pharmaceuticals) and EGIS Pharmaceuticals with respect to Actavis’ generic rosuvastatin zinc product.
New entrant to generic injectables market
Medical technology company Becton Dickinson announced on 28 March 2013 that FDA had approved the first drug in its line of prefilled generic injectables. This can only be good news for FDA who has been fighting to alleviate drug shortages in the US, most of which are due to shortages in generic sterile injectables.
Mylan launches generics and reaches settlement over metformin
Generics giant Mylan has launched generic versions of fenofibrate capsules, cidofovir injection and levalbuterol. The company has also resolved patent litigation with Shionogi and Andrx related to metformin.
Mylan to acquire Strides Arcolab’s injectable generics business
Generics giant Mylan announced on 27 February 2013 that it has signed an agreement to acquire generic injectables maker Agila Specialties (Agila) from Strides Arcolab for US$1.6 billion in cash.
Actavis confirms generic Alzheimer’s patch patent challenge
US generics maker Actavis (formerly Watson) confirmed on 8 March 2013 that it had filed with FDA an amendment to its abbreviated new drug application (ANDA) for rivastigmine transdermal system to include the 13.3 mg/24 hr dosage strength. Actavis’ product is a generic version of Novartis’ Exelon Patch, which is used to treat people with mild to moderate dementia associated with Alzheimer’s or Parkinson’s disease.
Pfizer delays generic celecoxib entry in US
Pharma giant Pfizer announced on 5 March 2013 that the US Patent Office had given the company an extra 18 months of exclusivity for its blockbuster anti-inflammatory painkiller Celebrex (celecoxib).
FDA approves generic opiate-dependency drugs
On 22 February 2013, FDA approved two generic versions of the drug Suboxone (buprenorphine/naloxone), a treatment for recovering heroin addicts.
Ranbaxy restarts generic atorvastatin production
India-based generics giant Ranbaxy Laboratories (Ranbaxy) announced on 25 February 2013 that it has restarted production of its generic cholesterol lowering drug atorvastatin after solving contamination problems.
Pfizer asks US Court to reconsider generic Reglan ruling
Pfizer has asked the US Supreme Court of Alabama to reconsider its decision of 4 January 2013, which would allow generics patients to sue brand-name drugmakers.
