November 08, 2014
Pharma Sector Update
(Sector Analysts: Kanika Singh, Neha Kumar and Ravi Karanam)
USFDA revokes Ranbaxy's 180-day exclusivity on sale of two generic drugs in US, grants approval to Dr. Reddy for one of them The USFDA has reverted its tentative approvals granting Ranbaxy six-months sales exclusivity of the generic versions of Roche's anti-viral drug Valcyte and AstraZeneca's heartburn pill Nexium. Ranbaxy had first-to-file status on both these drugs and it was expected to earn USD 60 million and USD 180 million from the generic versions of Valcyte and Nexium respectively in the exclusive sale period. The USFDA said that its original decision of granting tentative approvals were erroneous because of the compliance status of the facilities mentioned in the ANDAs (Abbreviated New Drug Application) filed by Ranbaxy, as a result of which in FDA's view, Ranbaxy had forfeited its eligibility for 180-day exclusivity for its ANDA for Valcyte. The news could hit the shares of Ranbaxy and Sun Pharma, already under CCI's scanner for the $4 billion M&A deal, the decision for which is expected this month. Earlier in the week,Ranbaxy had received approval from the USFDA to manufacture and market Fenofibrate capsules, used for lowering high cholesterol and triglyceride levels in the blood. The revocation of Ranbaxy's 180-day exclusivity on sale has turned out to be a positive news for Dr. Reddy's Laboratories which has been granted the final approval by USFDA to make cheaper versions of Valcyte. The company is expected to launch the drug shortly in the US market. ROC questions Plethico Pharmaceuticals over complaints from investors on the fixed deposit schemes The Registrar of Companies (ROC),Gwalior is inspecting the books of accounts of the Indore-based Plethico Pharmaceuticals, following hundreds of complaints received by the investor grievance cell of the corporate affairs ministry for almost a year. The investors...
Please join StudyMode to read the full document