Are you looking for the comprehensive list of the 2015 approved drugs in India, by the Central Drugs Standard Control Organization (CDSCO)? So, here we compiled a list with all the required information such as the drugs’ names, their indications, and approval dates.
What Are Drug Approval?
Drug Approval in India follows strict guidelines per the regulatory process under CDSCO and the Drugs & Cosmetics Act, of 1940. Before a drug is approved, it undergoes clinical trials, self-assessments and efficacy studies. It will help to ensure that the drugs meet the medical standards.
Why Is It Important To Check Drug Approval?
When you apply for drug approval then you must understand the importance of drug approval in India before regulating them. So the importance is as follows:
- Ensures safe and effective treatment.
- Helps healthcare professionals prescribe the latest medications.
- Allows pharmaceutical companies to keep track of new approvals.
- Informs patients about new treatment options.
Complete List of 2015 Approved Drugs in India
The below-mentioned table will conduct all 2015 approved drugs. It includes their usage and date of issue:
| S.No | Name of drug | Indication | Date of issue |
|---|---|---|---|
| 1 | Levocetirizine ODS 2.5mg /5mg (Additional dosage form) | For allergic rhinitis and chronic urticaria. | 14.01.15 |
| 2 | Decitabine Injection 30mg/vial (Additional pack size) | Treatment of Myelodysplastic Syndromes (MDS) and acute myeloid leukemia (AML) in patients aged 65+ years. | 13.02.15 |
| 3 | Meloxicam ODT 7.5mg /15 mg(Additional dosage form) | Non-steroidal anti-inflammatory | 23.02.15 |
| 4 | Ruxolitinib Tablet 5mg/15mg/20mg (Additional indication) | For patients with polycythemia vera resistant to hydroxyurea. | 23.02.15 |
| 5 | Gadopentetic acid dimeglumine salt injection 469mg/1ml (0.5mmol) (Additional indication) | For use in MRI in adult patients to facilitate visualization of lesions with abnormal vascularity in the body (excluding heart). | 23.02.15 |
| 6 | Pazopanib Tablet 200mg/400mg (additional indication) | For the treatment of patients with advanced Soft Tissue Sarcoma (STS) who have received prior chemotherapy. | 23.02.15 |
| 7 | Eribulin mesylate solution for injection 0.88mg in 2ml vial (Add. Indication) | Treatment of advanced or metastatic breast cancer. | 18.02.15 |
| 8 | Abiraterone acetate Tablet 250 mg (Additional Indication) | Used for metastatic castration-resistant prostate cancer. | 27.03.15 |
| 9 | Indomethacin Injection 1mg/vial (additional Dosage form) | Treatment of patent ductus arteriosus (PDA) in premature infants. | 30.04.15 |
| 10 | Ketorolac ODS 10mg (Additional Dosage form) | For the treatment of short-term management of post-operative pain and musculoskeletal pain. | 29.04.15 |
| 11 | Tiamulin hydrogen fumarate solution for injection 162 mg/ml (additional Dosage form) | For treatment and prevention of swine dysentery caused by Branchyspira hydodysenteriae. The product is not appropriate for use for the prevention of disease at the level of herd treatment but should only be used for the prevention of swine dysentery in individual animals with a known history of exposure to diseased animals. | 17.04.15 |
| 12 | Montelukast Orally Disintegrating Strips 4mg/5mg/10mg (additional Dosage form) | For the Relief of perennial allergic rhinitis in adults & pediatric patients 6 months of age and older. | 29.05.15 |
| 13 | Apixaban Tablets 2.5/5mg (additional Indication) | Treatment of deep vein thrombosis (DVT) and pulmonary Embolism (PE), and prevention of Recurrent DVT and PE in adult patients. | 29.05.15 |
| 14 | Ruxolitinib 10mg tablet (additional Strength) | Indicated for the treatment of severe malaria including cerebral malaria and as a second line in chloroquine-resistant malaria cases only. | 29.05.15 |
| 15 | Lorazepam Orodispersible Tablet 1mg/2mg (additional Dosage form) | For the management of anxiety disorders or the short-term relief of symptoms of anxiety or anxiety associated with depressive symptoms. | 29.05.15 |
| 16 | Brimonidine topical gel 0.33% (Add. Dosage form/indication) | For the topical treatment of persistent (nontransient) facial erythema of rosacea in adults 18 years of age or older. | 18.06.15 |
| 17 | Rivaroxaban tablet 2.5mg (add. strength) | Rivaroxaban 2.5mg tablet, co-administered with Acetylsalicylic acid (ASA) alone or with ASA plus Clopidogrel or Ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers. | 13.07.15 |
| 18 | Lamotrigine ER Tablet 25mg/50mg/100mg/200 mg | Add-on therapy for partial and secondary generalised tonic-clonic seizures. | 06.08.15 |
| 19 | Feracrylum 3% solution | For the management of post-operative wound cuts, Abrasions as a Haemostatic Agent cum anti-septic. | 13-02-15 |
| 20 | Feracrylum 3% gel | For the management of post-operative wound cuts, Abrasions as a Haemostatic Agent cum anti-septic. | 13-02-15 |
| 21 | Arteether injection 150mg/mL | For the prophylaxis of organ rejection in patients receiving a hepatic transplant. In liver transplantation, Everolimus should be used in combination with tacrolimus and corticosteroids. | 03-12-15 |
| 22 | Everolimus dispersible Tablet 0.1mg/0.25mg (additional Indication) | Prevention of premature ovulation in patients undergoing controlled ovarian stimulation, followed by oocyte pick-up and assisted reproductive techniques. | 21-08-15 |
| 23 | Everolimus Tablet 0.25 mg/0.5 mg/0.75 mg/1.0 mg (additional Indication) | For the prophylaxis of organ rejection in patients receiving a hepatic transplant. In liver transplantation, Everolimus should be used in combination with tacrolimus and corticosteriods. | 21-08-15 |
| 24 | Cetrorelix Acetate injection 0.25mg/0.5ml in 0.5 ml prefilled syringe. (Additional pack size) | Prevention of premature ovulation in patients undergoing controlled ovarian stimulation, followed by oocyte pick-up and assisted reproductive techniques. | 26-08-15 |
| 25 | Exenatide 2 mg powder and solvent for prolonged release suspension for injection in a prefilled pen (s.c. Injection) (Additional strength) | For treatment of type 2 diabetes mellitus in combination with Metformin Sulphonylurea Thiazolidinedione Metformin and Sulphonylurea Metformin and Thiazolidinedione In Adults who have not achieved adequate glycemic control on maximally tolerated doses of these oral therapies. | 09-09-15 |
| 26 | Vitamin D3 (Cholecalciferol) Orally disintegrating strips 2000 IU (additional Dosage form) | For the treatment of Vitamin D3 deficiency. | 01-10-15 |
| 27 | Dexamethasone Intravitreal implant 0.7mg (Additional Indication) | For the treatment of visual impairment due to Diabetic Macular Edema (DME) who are pseudophakic or who are considered insufficiently responsive to, or unsuitable for non-corticosteroid therapy. | 12-10-15 |
| 28 | Zolpidem Tartrate Orally disintegrating Tablet 5mg/10mg (Additional dosage form) | For insomnia. | 12-10-15 |
Key Takeaways For 2015 Approved Drugs
- In the year of 2015 multiple new drug formulations, dosage forms, and indications were approved.
- Cancer treatments, anti-inflammatory drugs, anticoagulants, and transplant medicines were among the major approvals.
- These approvals reflect advancements in healthcare and better treatment options for patients.
Conclusion
This list of 2015 approved drugs in India provides essential information on newly approved treatments and additional indications. It helps doctors, researchers, and pharmaceutical companies stay updated on the latest advancements in medicine.
For more updates on CDSCO drug approvals, pharmaceutical regulations, and healthcare advancements, stay connected with Medical Device Registration.
How Can I Verify If A Drug Is CDSCO Approved?
You can check the CDSCO website or refer to the official Gazette Notifications for the latest drug approvals.
What Is The Significance Of Additional Indications In Drug Approvals?
Some drugs initially approved for a specific condition are later found to be effective for other diseases, leading to new approvals.
Are These Drugs Available In India Now?
Most drugs approved in 2015 are still available, but it is essential to consult a doctor before using them.
Where Can I Find The Latest List Of Drug Approvals?
CDSCO regularly updates its drug approval list, and you can access it on the official website or contact a regulatory consultant. 🔹 Need regulatory assistance? Contact us today for CDSCO approval consultations!
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