Annora's Generic Promethazine Hydrochloride Receives Approval in the U.S.
Quagen`s Generic Codeine Phosphate;Promethazine HCL Receives Approval in US
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 21 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
In a ruling published Wednesday, the UK's Advertising Standards Authority (ASA) upheld a complaint against Sanofi UK ruling that a paid promotion of the company's pharmacy-only Phenergan Night Time (promethazine hydrochloride) tablets on a parenting blogger's Instagram in February violated its advertising code.
The health ministry has decided to ban 328 combination medicines following recommendations to do so by its technical advisory body over a month ago, ET has learnt. It is also restricting the manufacture, sale and distribution of six other combination medicines, as recommended by the body.
Mumbai: The proposed government ban on over 340 combination medicines (fixed-dose combinations, or FDCs) will impact over 2% — nearly Rs 2,900 crore — of the organised retail market, with popular cough syrups, painkillers and flu medicines — like Phensedyl, Saridon, Sumocold, and Vicks Action 500 — facing action. A final decision on the ban is expected soon by health ministry, even as an expert panel — the Drug Technical Advisory Board, or DTAB — earlier recommended these “irrational and “harmful” medicines should be taken off the shelves.
The move, which is expected to impact top MNCs such as Abbott as well as domestic players such as Piramal, Macleods, Cipla and Lupin among others, could be challenged in the courts once again.
Strides Pharma’s Generic Promethazine Hydrochloride Receives Tentative Approval In US
The Delhi High Court granted an interim injunction to drugmaker Abbott against a government move to ban Phensedyl, one of the top-selling cough syrups in India. The next hearing is scheduled for March 21. Annual sales of Phensedyl amount to Rs 252 crore, according to market research agency Pharma Trac.
In a significant move ensuring safety and efficacy of medicines, the health ministry has banned around 350 fixed dose combination (FDC) drugs that were widely available in the market till now. These medicines include FDCs based on codine, used in popular cough syrups like Phensedyl and Corex.