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Recommendations of the SEC (Pulmonary) made in its 43rd meeting held on 27.02.2020 at CDSCO HQ New Delhi:

Agenda File Name & Drug Firm Name Recommendations No Name, Strength New Drugs Division 1. The firm presented the results of Bioequivalence study and as 12-16/18-DC per the protocols approved earlier. FDC of Bilastine 20 mg M/s. Hetero After detailed deliberation, the committee and 10 mg Labs recommended for grant of permission to manufacture and market the FDC for treatment of Allergic rhinitis in adults. 2. The committee deliberated that there has 12-01/12-DC (Pt-9 been no issue regarding safety/efficacy Doxophylline) PSC profile of the drug in present context and Doxophylline recommended for continued marketing of the drug in the country . SND Division 3. The firm presented the proposal for additional indication of the drug along with the results of the global clinical trial in which India was one of the participating SND/IMP/19/000107 countries. Nintedanib Soft Gelatin M/s Boehringer The additional indication is already Capsules 100mg & Ingelheim approved in many countries including US, 150mg Canada, Japan etc. After detailed deliberation, the committee recommended for the grant of permission to market the drug for the proposed indication. 4. In light of the earlier recommendation of the SEC meeting dated 25/09/2019, the firm presented their justification for approval of the product from prescription to non-prescription status before the committee. The firm presented that they 12-142/2009-DC did not have any information regarding M/s Rubicon Dextromethorphan HBr abuse potential of the proposed product in Research Pvt. Extended Release Indian scenario. The Dextromethorphan Ltd., Suspension 30mg/5ml lozenges 10mg is already approved as non- prescription drug. After detailed deliberation, the committee recommended that there may be no objection for approval of the proposal subject to concurrence of SEC (Neurology and Psychiatry). 5. The firm presented the proposal for SND/IMP/20/000005 approval of the drug in pediatric patients M/s Johnson & Bedaquiline Tablets (12 years to less than 18 years of age and Johnson 100mg weighting at least 30 kg). After detailed deliberations, the committee

43rd SEC (Pulmonary)_27.02.2020

Agenda File Name & Drug Firm Name Recommendations No Name, Strength recommended for approval of the drug in the proposed age group subject to the same condition of conditional access through NTEP (RNTCP) as approved earlier for adult. However, concurrence of Central TB division should be obtained before grant of approval by CDSCO. 6. The firm presented their proposal along with pharmacokinetic study data. The committed noted the drug (as SND/MA/20/000023 salt) is already approved in US. Levosalbutamol Tartrate M/s. Glenmark After detailed deliberation, the committee Inhalation Aerosol Pharmaceuticals recommended for grant of permission to (Levosalbutamol 45 mcg/ manufacture and market the drug actuation) Levosalbutamol Tartrate Inhalation Aerosol (Levosalbutamol 45 mcg/ actuation). FDC Division 7. FDC/MA/19/000048 M/s. Synokem The firm presented the results of Montelukast Sodium Eq. Pharmaceuticals Bioequivalence study and Clinical trial as to Montelukast per the protocols approved earlier. IP+Bilastine After detailed deliberation, the committee (10mg+20mg) Film recommended for grant of permission to coated bilayered Tablet manufacture and market the FDC for treatment of Allergic rhinitis in adults. 8. FDC/MA/19/000072 M/s. Synokem The firm presented the proposal along with Montelukast Sodium IP Pharmaceuticals BE study protocol and requested for Eq. to Montelukast clinical trial waiver. +Bilastine (4mg+10mg) The committee noted that both the suspension individual drugs are approved in suspension form for paediatric use. After detailed deliberation, the committee recommended for grant of permission to conduct the proposed Bioequivalence study. The results of Bioequivalence study should be presented before the committee for further consideration including the requirement of conducting clinical trial. 9. FDC/MA/19/000144 M/s. Akums The firm presented CT and BE protocol Bilastine before the committee. 20mg+Montelukast After detailed deliberation, the committee Sodium IP eq. to recommended for grant of permission to Montelukast 10mg tablet conduct the Phase III CT and BE study. 10. FDC/MA/20/000001 M/s. Lupin Ltd. The firm presented their proposal for approval of the additional strength of the Fumarate12mcg+Budeso FDC. nide 400mcg inhaler After detailed deliberation, the committee recommended that the firm should submit detailed published evidences/documents in support of safety of the proposed FDC

43rd SEC (Pulmonary)_27.02.2020

Agenda File Name & Drug Firm Name Recommendations No Name, Strength which contains higher strength of LABA and ICS for further review by the committee. 11. FDC/MA/19/000003 M/s. Ajanta The firm did not turn up for the Bilastine 20mg/20mg + Pharma Ltd. presentation. Montelukast Sodium IP eq. to Montelukast 10mg/5mg film coated tablet 12. FDC/IMP/19/000049 M/s In light of earlier recommendation of the Furoate + GlaxoSmithKlin committee dated 20.12.2019, the firm Umeclidinium + e presented their proposal along with the trifenatate Pharmaceuticals following details: (100mcg+62.5mcg+25mc Ltd., 1. Subset analysis of safety data w.r.t g) power for Inhalation to Pneumonia and cardiac adverse effect. 2. Update on PMS findings and global PBRER data reports created since launch of the product in other countries. 3. Subset analysis of data generated from Asian Region. From the detailed presentation, the firm concluded that, the efficacy and safety profile of the product observed in the global clinical development program are relevant to patients with COPD in Asia. Based on the totality of the clinical data, the product was presented to be low ethnic sensitivity for treatment of COPD in Asian subjects. The same dose is used in Asia and west. The Drug is already approved in 51 countries including USA, Japan, EU, etc. After detailed deliberation, the committee recommended for grant of permission for Import and Marketing of the drug with local clinical trial waiver subject to the condition that the firm should submit Phase IV Clinical trial protocol within 3 months of the approval of the Drug. 13. The firm presented their proposal along with the rationality and clinical trial FDC/MA/20/000013 protocol for the indication “as add-on Acebrophylline M/s Sun Pharma therapy in patients in uncontrolled 100mg+Lavosalbutamol Laboratories ”. sulphate IP eq. to Ltd. After detailed deliberation, the committee Lavosalbutamol 2mg opined that the rationality including safety uncoated tablets of the FDC for the proposed indication in light of the clinical trial protocol presented

43rd SEC (Pulmonary)_27.02.2020

Agenda File Name & Drug Firm Name Recommendations No Name, Strength is not appropriate as per the standard treatment guidelines. Hence the committee did not recommend for approval of the CT protocol. 14. Firm presented their proposal along with Phase-III CT protocol before the committee. FDC/MA/20/000001 After detailed deliberation, the committee Fluticasone Furoate 27.5 recommended that the firm should submit M/s. Cadila mcg + the rationality including pharmacokinetic Healthcare Ltd. Hydrochloride IP 50 mcg compatibility of the FDC for further Nasal Spray consideration. The committee also opined that an ENT specialist may also be invited in the next meeting for further deliberation.

43rd SEC (Pulmonary)_27.02.2020