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Generics/News

Acyclovir V13D19

Mylan gains approval for generic of Valeant’s Zovirax

Generics/News | Posted 19/04/2013

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%.

Rosuvastatin V13D19

AstraZeneca settles rosuvastatin lawsuit

Generics/News | Posted 19/04/2013

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.

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New entrant to generic injectables market

Generics/News | Posted 12/04/2013

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.

Generic V13C05

Mylan launches generics and reaches settlement over metformin

Generics/News | Posted 05/04/2013

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/News | Posted 15/03/2013

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.

Exelon patch

Actavis confirms generic Alzheimer’s patch patent challenge

Generics/News | Posted 22/03/2013

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.

Celecoxib V13c08

Pfizer delays generic celecoxib entry in US

Generics/News | Posted 08/03/2013

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).

Harvesting_opium V13c08

FDA approves generic opiate-dependency drugs

Generics/News | Posted 08/03/2013

On 22 February 2013, FDA approved two generic versions of the drug Suboxone (buprenorphine/naloxone), a treatment for recovering heroin addicts.

Atorvastatin-3D-vdW

Ranbaxy restarts generic atorvastatin production

Generics/News | Posted 01/03/2013

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.

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Pfizer asks US Court to reconsider generic Reglan ruling

Generics/News | Posted 22/02/2013

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.