Us Generic Drug Concerns
Granules India gets USFDA nod for generic drug used to treat heartburn
Granules India Ltd on Thursday said it has received approval from the US health regulator for its generic Esomeprazole Magnesium delayed-release capsules indicated for short-term treatment of heartburn and other symptoms associated with gastroesophageal reflux disease. The approval by the US Food & Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) for Esomeprazole Magnesium delayed-release capsules of strengths 20 mg and 40 mg, Granules India said in a regulatory filing. It is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Nexium Delayed-Release Capsules, 20 mg and 40 mg, of AstraZeneca Pharmaceuticals LP. Esomeprazole Magnesium capsules are indicated for short-term treatment of heartburn and other symptoms associated GERD, risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults and long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison ...
 "Granules India gets USFDA nod for generic drug used to treat heartburn")
Intense price competition in US generics market hits Indian pharma
Players say low prescription, double-digit price erosion are key reasons
 "Intense price competition in US generics market hits Indian pharma")
Price-fixing charges: Sun Pharma in talks with US to end anti-trust probe
Prosecutors have been investigating allegations that generic drugmakers conspired to prop up the prices of certain widely used medications for more than five years
 "Price-fixing charges: Sun Pharma in talks with US to end anti-trust probe")
Plans to slash medical costs in the US run into generic drug concerns
FDA reports show some workers in India destroyed records to keep regulators in the dark about production issues
 "Plans to slash medical costs in the US run into generic drug concerns")
