Generics/News
First generic 30 mg Focalin XR capsules approved
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
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
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
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
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
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
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treatment Advair (fluticasone/salmeterol) could face competition from generics sooner than expected, after FDA issued draft guidance on generics of the drug.
