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Perrigo receives tentative FDA approval for generic Prandin

US-based drugmaker Perrigo Company (Perrigo) announced on 19 July 2013 that it had received tentative approval from FDA for its abbreviated new drug application (ANDA) for repaglinide tablets.

Teva loses fight against generic glatiramer acetate

On 26 July 2013 the US Federal Circuit Court of Appeals invalidated several of Teva’s patents on Copaxone (glatiramer acetate), including one that protected the drug until September 2015.

Ranbaxy faces lawsuit in India

An Indian lawyer has filed a lawsuit asking the Indian Supreme Court to investigate Ranbaxy Laboratories (Ranbaxy), its executives and Indian drug control officers, as well as to shut down two of Ranbaxy’s Indian plants.

Actavis submits ANDAs for two more generics

Actavis has filed for US approval for generic versions of a contraceptive and a sedative/anaesthetic.

Teva and Sun Pharma settle battle over generic Protonix

Pfizer announced on 12 June 2013 that the pharma giant had reached a settlement with generics manufacturers Teva Pharmaceuticals Industries (Teva) and Sun Pharmaceutical Industries (Sun Pharma) for damages resulting from their ‘at-risk’ launches of generic pantoprazole in the US.

Dr Reddy’s and Fujifilm call off joint venture for generics in Japan

Two years after signing a deal to work together on generics in Japan, Fujifilm Corporation (Fujifilm) and Dr Reddy’s Laboratories (Dr Reddy’s) have called off their agreement.

US appeals court halts Pulmicort generics

On 25 May 2013, the US Court of Appeals for the Federal Circuit issued a temporary injunction in the US stopping generics of AstraZeneca’s asthma treatment Pulmicort Respules (budesonide inhalation suspension).

Ranbaxy pays US$500 million to resolve US litigation

In what has been hailed as the largest ever settlement of its kind involving a drug safety settlement with a generics manufacturer, Ranbaxy Laboratories (Ranbaxy) pleaded guilty to violations of the Food, Drug and Cosmetics Act (FDCA) and making false statements.

Sanofi fined for discouraging generic clopidogrel prescriptions

On 14 May 2013, French drugmaker sanofi-aventis was fined Euros 40.6 million by the French competition authority (L’Autorité de la concurrence) for marketing practices that discouraged sales of generic versions of its blood thinner Plavix (clopidogrel).

FDA rejects Endo petition to stop Opana ER generics

On 10 May 2013, FDA announced that it had rejected a petition by Endo Pharmaceuticals (Endo) to stop generics of its powerful painkiller, Opana ER (oxymorphone).

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