Food And Drug Administration
Glenmark Generics Inc., USA a subsidiary of Glenmark Generics has been granted final abbreviated new drug approval (ANDA) from the United States Food and Drug Administration (US FDA) for Telmisartan Tablets. Glenmark will commence distribution of the product immediately.
12.04 PM Jul 8th 2014
Jun 05, 2014, 04.15 PM IST | Source: PTI Wockhardt recalls 8712 hypertension drug bottles in US mkt According to US Food and Drug Administration (USFDA), Wockhardt USA Inc, a subsidiary of Mumbai-based firm is voluntarily recalling 8,712 bottles of the drug in the American market.
10.30 AM Jul 7th 2014
Ranbaxy Laboratories Ltd has received approval from the US Food and Drug Administration (FDA) to launch a cheaper copy of Novartis AG`s blood pressure pill Diovan. Ranbaxy will be the first rival drug maker to launch a copy of Diovan in the United States and will be entitled to six months
10.20 AM Jun 30th 2014
Strides Arcolab has received regulatory approval to market a skin disease drug in the US. The US Food and Drug Administration (FDA) has allowed the company to sell Methoxsalen capsules of 10 mg strength, Bangalore-based Strides Arcolab said in a statement. The US market for generic Methoxsalen
12.33 PM Jun 9th 2014
he U.S. Food and Drug Administration has expressed concerns over production processes at the U.S. unit of Wockhardt and there is a real possibility that its USA unit is banned by USFDA. If that happens the share will sink below 400. For the time being IMO,it will go down to 450-500 range.
10.16 AM May 29th 2014
Reuters) - The U.S. Food and Drug Administration has expressed concerns over production processes at the U.S. unit of Wockhardt Ltd (WCKH.NS), a top executive said, possibly adding to a spate of regulatory troubles facing the Indian generic drugmaker. The United States is Wockhardt`s biggest
1.01 PM May 28th 2014
Source:NDTV Profit - Mumbai: The US Food and Drug Administration (FDA) has made some observations about the production process of the US unit of Indian generic drugmaker Wockhardt Ltd, the company said on Tuesday. The FDA last year banned Wockhardt's two Indian ...
7.12 PM May 27th 2014
before the patent on the medication expires. Teva’s lawsuit, accusing the Food and Drug Administration of improperly dismissing its calls for more testing of generic forms of Copaxone before they go on the U.S. market, was thrown out yesterday by a federal judge in Washington. Copaxone, the company
4.09 PM May 18th 2014
to increased scrutiny from regulators concerned that the quality of drugs made in that country aren’t up to US standards. The concerns prompted Margaret Hamburg, the commissioner of the US Food and Drug Administration (FDA), to go to India in February to meet with pharmaceutical makers there about production
12.14 PM May 15th 2014