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Generics/News

Viagra V13F28

Australia approves first capsule-form Viagra generic

Generics/News | Posted 14/09/2018

Singapore-based iX Biopharma announced on 6 August 2018 that it had received approval from Australia’s Therapeutic Goods Administration (TGA) for its sildenafil drug, which is delivered in an oral capsule for treating erectile dysfunction.

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Generic diabetes and cancer drugs pose challenge to Bristol-Myers Squibb and Eli Lilly

Generics/News | Posted 07/09/2018

Generics manufacturers in Bangladesh and Germany have recently announced the launch of generic versions of Bristol-Myers Squibb’s diabetes treatment Glucophage and Eli Lilly’s lung cancer drug Pemetrexed.

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Ulcerative colitis and diabetes generics launched in US

Generics/News | Posted 31/08/2018

Israeli generics giant Teva Pharmaceutical Industries (Teva) announced on 9 July 2018 that it had launched generic budesonide extended-release tablets (9 mg) in the US. Then on 25 July 2018, Sun Pharmaceutical Industries (Sun Pharma), one of India’s largest pharmaceutical manufacturers, announced that it had launched generic metformin extended-release tablets (500 and 1,000 mg) in the US.

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Generic cancer pain relief launched in Japan

Generics/News | Posted 20/07/2018

Japan-based Daiichi Sankyo announced on 15 June 2018 that it had launched a generic version of cancer pain relief Fentos Tape (fentanyl citrate tape).

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FDA approves first Suboxone generics for opioid dependence

Generics/News | Posted 13/07/2018

The US Food and Drug Administration (FDA) announced on 14 June 2018 that it had approved the first generics of Suboxone (buprenorphine/naloxone) sublingual film (applied under the tongue) for the treatment of opioid dependence. The generics have been developed by Indian generics maker Dr Reddy’s Laboratories (Dr Reddy’s) and US-based drugmaker Mylan.

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US approval for prostate cancer formulation and impotence generics

Generics/News | Posted 22/06/2018

The US Food and Drug Administration (FDA) has approved generics of tadalafil, used to treat male impotence, and a new abiraterone formulation, a treatment for prostate cancer.

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Aurobindo and Lannett expand their generics portfolios

Generics/News | Posted 15/06/2018

Both Indian generics maker Aurobindo Pharma (Aurobindo) and US generics company Lannett have announced efforts to increase their generics portfolios.

Imatinib V13D12

Price of leukaemia drug in Japan halved

Generics/News | Posted 25/05/2018

Japanese drugmaker Ohara Pharmaceutical has reduced the price of its leukaemia generic imatinib to about half the price of the generics sold by its competitors to encourage leukaemia patients to use more affordable medication.

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Hikma launches HIV generic ritonavir in the US

Generics/News | Posted 18/05/2018

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.

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Alvogen receives European approval for generic lenalidomide

Generics/News | Posted 11/05/2018

US generics company Alvogen announced on 24 April 2018 that it had successfully concluded multiple registration procedures for its lenalidomide generic capsules.

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Teva launches ulcerative colitis generic in the US

Generics/News | Posted 27/04/2018

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.

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Australia’s Mayne Pharma launches generic antibiotic in US

Generics/News | Posted 13/04/2018

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.

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GSK fined GBP 37.6 million in pay-for-delay appeal

Generics/News | Posted 30/03/2018

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).

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Lupin launches generic memantine XR capsules in the US

Generics/News | Posted 16/03/2018

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).

Pay for Delay DrugsMoneyGeneric V13F21

Price of Teva’s new rare disease generic shocks patients

Generics/News | Posted 02/03/2018

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.

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Hospitals to start own generics company

Generics/News | Posted 26/01/2018

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.

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Mylan appeals to FDA: no approval for generic Advair Diskus based on multi-batch PK BE studies

Generics/News | Posted 19/01/2018

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. 

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Mylan/Aspen launch generic busulfan injection

Generics/News | Posted 08/12/2017

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).