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Actavis submits generic dalfampridine ANDA

Acorda Therapeutics (Acorda), announced on 26 June 2014 that it had received a Paragraph IV Certification Notice Letter advising the company that Actavis Laboratories (Actavis) had submitted an abbreviated new drug application (ANDA) to the US Food and Drug Administration (FDA) for the approval of a generic version of the company’s multiple sclerosis drug, Ampyra (dalfampridine).

Generic valsartan approved in US

India’s largest generics maker Ranbaxy Laboratories announced on 27 June 2014 that its subsidiary, US-based Ohm Laboratories (Ohm), had received approval from the US Food and Drug Administration (FDA) for generic valsartan.

Teva settles patent litigation over ProAir HFA

The world’s biggest generics maker, Teva Pharmaceutical Industries (Teva), announced on 20 June 2014 that it had reached a settlement with Perrigo Pharmaceutical (Perrigo) and Catalent Pharma Solutions (Catalent) with respect to Teva’s respiratory product ProAir HFA (albuterol sulfate).

Actavis settles Nuvigil patent litigation, challenges Onglyza patent

US generics major Actavis has settled patent litigation related to Actavis’ generic version of Nuvigil (armodafinil) and confirmed its generic Onglyza (saxagliptin) patent challenge.

First generic celecoxib approved by FDA

The US Food and Drug Administration (FDA) announced on 30 May 2014 that it had approved the first generic versions of celecoxib capsules.

Sun Pharma’s Gujarat site under FDA import alert

Sun Pharmaceutical Industries’ (Sun Pharma) response to the US import ban on products produced at the company’s Gujarat site is inadequate, according to a warning letter issued by the US Food and Drug Administration (FDA) on 7 May 2014.

Novartis settles Gleevec lawsuit with Sun Pharma

Sun Pharmaceutical Industries (Sun Pharma) announced on 15 May 2014 that it had reached a settlement agreement with originator drug developer Novartis over litigation concerning generic Gleevec (imatinib mesylate).

FDA sued over generic celecoxib approval

Generics makers Actavis and Mylan Pharmaceuticals (Mylan) have sued the US Food and Drug Administration (FDA) over the agency’s decision to award exclusive rights to Teva Pharmaceutical Industries (Teva) to sell a generic version of Pfizer’s blockbuster anti-inflammatory painkiller Celebrex (celecoxib).

Taiwan TWi gains FDA approval for generic nifedipine

Taiwan’s TWi Pharmaceuticals (TWi) announced on 7 April 2014 the approval of its abbreviated new drug application (ANDA) for generic nifedipine by the US Food and Drug Administration (FDA).

Dr Reddy’s launches generic amlodipine/atorvastatin

Indian generics giant Dr Reddy’s announced on 27 March 2014 the launch of its generic amlodipine/atorvastatin tablets in the US.

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