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Forest initiates lawsuits over generic Savella

Forest Laboratories and Forest Laboratories Holdings (Forest) announced that Forest and Royalty Pharma Collection Trust (Royalty Pharma) are suing several generics manufacturers regarding generics of Savella (milnacipran).

FDA approves generic version of cancer drug

FDA announced on 16 September 2013 that it had approved Teva Pharmaceutical Industries (Teva’s) generic version of Roche’s cancer drug Xeloda (capecitabine).

Generics of fish oil cholesterol treatment get go ahead

A US appeals court ruled on 12 September 2013 that generics companies can develop their own versions of Lovaza, a fish oil-derived drug used to treat high cholesterol, which is currently marketed in the US by GlaxoSmithKline (GSK).

Advair could face competition from generics as early as 2016

GlaxoSmithKline’s (GSK) asthma and chronic obstructive pulmonary disorder treatment Advair (fluticasone/salmeterol) could face competition from generics sooner than expected, after FDA issued draft guidance on generics of the drug.

Ranbaxy receives another import ban from FDA

Ranbaxy Laboratories (Ranbaxy) has come into FDA’s firing line again. This time generics manufacturer is under scrutiny for problems at its Mohali manufacturing site.

Avanir and Wockhardt settle Nuedexta patent dispute

US-based Avanir Pharmaceuticals (Avanir) announced on 6 September 2013 that it had entered into a settlement agreement with Wockhardt USA, the US subsidiary of India-based generics maker Wockhardt, regarding Nuedexta (dextromethorphan hydrobromide/quinidine sulfate).

Actavis confirms Rayos patent challenge and Warner Chilcott acquisition

Actavis has filed for US approval for a generic version of the anti-inflammatory or immunosuppressive agent Rayos (prednisone). The company also confirmed its proposed acquisition of Warner Chilcott.

Ranbaxy to expand Russian portfolio

Generics manufacturer Ranbaxy Laboratories (Ranbaxy) has been in the Russian pharmaceuticals market for 20 years and is now considering expanding its product offering in the country.

Mylan and Par pass FDA scrutiny on Wellbutrin generics

Mylan and Par Pharmaceutical (Par) announced on 20 and 22 August 2013, respectively, that they have passed FDA scrutiny of their generics of antidepressant Wellbutrin XL (bupropion).

Allergan objects to Restasis generics being accepted without human trials

Following the publishing of draft guidance on cyclosporine by FDA, ophthalmic specialist Allergan is requesting that FDA revise its guidance on cyclosporines, arguing that generic versions of its eye drug Restasis (cyclosporine ophthalmic emulsion) should be tested in humans before approval, not just in a laboratory.

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