Generics/News
Hikma launches HIV generic ritonavir in the US
Jordan-based drugmaker Hikma Pharmaceuticals (Hikma) announced on 20 March 2018 that its wholly owned US subsidiary West-Ward Pharmaceuticals Corp had launched generic ritonavir tablets (100 mg) in the US.
Alvogen receives European approval for generic lenalidomide
US generics company Alvogen announced on 24 April 2018 that it had successfully concluded multiple registration procedures for its lenalidomide generic capsules.
Teva launches ulcerative colitis generic in the US
Israeli generics giant Teva Pharmaceutical Industries (Teva) announced on 26 March 2018 that it had launched generic mesalamine delayed-release tablets (1.2 g) in the US.
Australia’s Mayne Pharma launches generic antibiotic in US
Australia-based Mayne Pharma announced on 15 March 2018 that it had launched a generic version of doxycycline monohydrate immediate release (IR) capsules (50, 75 and 100 mg) in the US.
GSK fined GBP 37.6 million in pay-for-delay appeal
GlaxoSmithKline (GSK) has lost its appeal over a pay-for-delay case dating back to the early 2000s and involving its now off-patent antidepressant Seroxat/Paxil (paroxetine).
Lupin launches generic memantine XR capsules in the US
India-based generics manufacturer Lupin Pharmaceuticals (Lupin) announced on 21 February 2018 that it had launched a generic version of Allergan’s Alzheimer’s disease treatment Namenda XR (memantine XR).
Price of Teva’s new rare disease generic shocks patients
On 9 February 2018, Israeli generics giant Teva Pharmaceutical Industries (Teva) announced the launch of its generic version of Syprine (trientine hydrochloride) capsules, 250 mg, in the US. However, what the company termed a ‘lower-cost generic alternative’ has turned out to be almost as expensive as the originator product.
Hospitals to start own generics company
In an effort to combat regular shortages and the increasing prices of drugs, four of the US’s largest hospital systems have made plans to create a non-profit generics company.
Mylan appeals to FDA: no approval for generic Advair Diskus based on multi-batch PK BE studies
On 5 December 2017, Mylan filed a citizen petition asking the US Food and Drug Administration (FDA) not to approve any abbreviated new drug applications (ANDAs) for generic versions of Advair Diskus that rely on data from multiple-batch studies to demonstrate pharmacokinetic (PK) bioequivalence (BE). The agency’s guidance on evaluating generic bioequivalence for this Glaxo Smith Kline asthma drug, specifies a single-batch trial design and Mylan is requesting that this is adhered to.
Mylan/Aspen launch generic busulfan injection
US generics giant Mylan Pharmaceuticals (Mylan) and its partner, generics manufacturer Aspen Pharmacare Holdings (Aspen), announced on 4 December 2017 that it had launched generic Myleran (busulfan) single-dose vial in the US, after receiving final approval from the US Food and Drug Administration (FDA).
