Generics/News

First generic 30 mg Focalin XR capsules approved

Generics/News | Posted 22/11/2013

On 18 November 2013, Mylan Pharmaceuticals announced the launch of generic dexmethylphenidate hydrochloride extended-release (ER) capsules, 30 mg.

Ranbaxy sues Actavis over generic acne drug

Generics/News | Posted 15/11/2013

Indian generics giant Ranbaxy Laboratories (Ranbaxy) is suing US generic drugmaker Actavis to try to stop the latter marketing a generic version of Ranbaxy’s acne drug Absorica (isotretinoin).

Good news for Ranbaxy plant in US

Generics/News | Posted 08/11/2013

Ranbaxy Laboratory’s (Ranbaxy) US-based plant, Ohm Laboratories (Ohm), has successfully passed an FDA inspection, according to an announcement on the generic drugmaker’s website.

FDA approves generic tobramycin inhalation solution

Generics/News | Posted 31/10/2013

Teva Pharmaceutical Industries (Teva) announced on 14 October 2013 that the US Food and Drug Administration (FDA) had granted approval for its abbreviated new drug application (ANDA) for tobramycin inhalation solution.

Making generics of Advair could be difficult

Generics/News | Posted 25/10/2013

GlaxoSmithKline’s (GSK) fears of generics competition for its chronic obstructive pulmonary disorder treatment Advair (fluticasone/salmeterol) may be unfounded according to generics manufacturer Teva Pharmaceutical Industries (Teva).

US court paves way for Nexium competition

Generics/News | Posted 18/10/2013

AstraZeneca announced on 2 October 2013 that the US Court of Appeals for the Federal Circuit had lifted a temporary injunction against the US launch of Hanmi Pharmaceutical’s (Hanmi’s) esomeprazole strontium product.

Forest initiates lawsuits over generic Savella

Generics/News | Posted 18/10/2013

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

Generics/News | Posted 11/10/2013

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

Generics/News | Posted 04/10/2013

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

Generics/News | Posted 27/09/2013

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

Generics/News | Posted 27/09/2013

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

Generics/News | Posted 20/09/2013

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

Generics/News | Posted 13/09/2013

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/News | Posted 13/09/2013

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

Generics/News | Posted 06/09/2013

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

Generics/News | Posted 30/08/2013

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.