Cipla arm recalls multiple lots of antidepressant drug from US market

Pharma major Cipla's arm InvaGen Pharmaceuticals Inc is recalling 11 lots of antidepressant bupropion HCl extended-release tablets from the US market due to failed dissolution specifications, latest enforcement report of the US health regulator has said.

InvaGen Pharmaceuticals Inc is recalling four lots of bupropion HCl extended-release tablets USP (SR) in the strength of 100 mg, United States Food and Drug Administration (USFDA) said in an enforcement report.

The company is also recalling seven lots of the tablets in the strength of 150 mg, it added.

The report, however, did not mention the quantity of the product.

The ongoing nationwide voluntary recall for both the strengths is on account of "failed dissolution specifications; during stability testing," it added.

Delhi HC upholds order restricting sale of Cipla's respiratory disease drug

Latest News - A division bench of the Delhi High Court on Thursday upheld a single judge order restraining Cipla from selling its respiratory disease drug – Indaflo.  Cipla had launched the drug in the Indian market in 2014 under the name Unibrez, while also calling for the revocation of five Novartis patents on Indacaterol, the generic version of the respiratory medicine. 

Cipla later had to change the name Unibrez to Indaflo, after a court order held the earlier name as infringing on the trademark of Novartis’s own variant – Onbrez. After winning the first round in court, Novartis filed a separate suit for permanent injunction claiming the infringement of its patent on Indacaterol by Cipla. 

Novartis’s bid to stop Cipla from selling Indacaterol in its entirety became a reality after a single judge bench in January 2015, restrained Cipla from selling their version of the drug, until otherwise allowed a compulsory license to sell the medicine from a (Read More)