Three Indian firms get USFDA nod for cholesterol drug
The Dollar Business Bureau Three Indian companies, Aurobindo Pharma, Glenmark and Sun Pharma, have got the approval from the USFDA (United States Food and Drug Administration) to sell the generic versions of the famous drug Crestor prescribed for cholesterol, in the US market. The nod, given by the US health regulator to these three domestic companies, is for the generic rosuvastatin calcium tablets in 5 mg, 10 mg, 20 mg and 40 mg strengths. “We are one of the first ANDA (Abbreviated New Drug Application) applicants to file a significantly complete application with a paragraph IV certification. Hence, we are eligible for six months shared exclusivity of the generic drug. The drug is launched in the American market,” Aurobindo ...
Aurobindo Pharma receives USFDA approval
The Dollar Business Bureau Aurobindo Pharma, a Hyderabad-based company, has announced that it has finally received approval to manufacture and market Oxymorphone Hydrochloride and Famotidine tablets from the United States Food and Drug Administration (USFDA). The approved Abbreviated New Drug Application (ANDA) is bio and therapeutic equivalent to listed drug under Reference Listed Drug (RLD). Manufactured by Endo Pharmaceuticals, Inc., Oxymorphone Hydrochloride is a pain relief drug for moderate to acute pain, wherever the prescription of Opioid is appropriate. As approved by ANDA, dosages must be 5mg and 10mg. According to IMS Health, the product has a market size of $55.5 million for a period of 12-months, ending February 2016. While, Famotidine tablets (ANDA approved dosages for this drug is ...
Indian pharma company gets nod to sell hepatitis B medicine in US
The Dollar Business Bureau United States drug regulator has granted its nod to India’s Aurobindo Pharma to manufacture and sell in the American market the generic drug meant for those infected with hepatitis B virus. Aurobindo Pharma Limited “has received the final approval from the US Food and Drug Administration (USFDA) to manufacture and market Entecavir Tablets, 0.5mg and 1mg,” the company said in a statement on Thursday. The Hyderabad-based firm had sought nod under the Abbreviated New Drug Application (ANDA) which is applicable for generic drugs that are similar to innovator’s medicine in terms of impact on patients. “The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Baraclude® Tablets, 0.5mg and 1mg, of Bristol-Myers ...
